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Intraoperative Floppy Iris Syndrome:
Pearls for Management and Prevention
Senior Instructor: David F Chang MD
Course: 214
Sunday, October 16, 2016
10:15 AM - 11:15 AM
Room: E451A
Published: 8-12-16 12:55 AM
Join the conversation: #aao2016
© 2016 American Academy of Ophthalmology. All rights reserved.
1
Intraoperative Floppy Iris Syndrome
David F. Chang, MD
Intraoperative floppy iris syndrome (IFIS) in association with current or prior tamsulosin (Flomax) use
was first described in 20051
. Besides a tendency for poor preoperative pupil dilation, severe IFIS
exhibits a triad of intraoperative signs – iris billowing and floppiness, iris prolapse to the main and side
port incisions, and progressive intraoperative miosis. Numerous studies have confirmed our initial
suspicion that when such iris behavior is unexpected, the rate of cataract surgical complications is
increased2-7
. Based upon parallel large retrospective and prospective clinical studies that John Campbell
and the author had conducted, we identified a strong association of IFIS with either current or prior use
of tamsulosin1
. This systemic alpha-1 antagonist is the most commonly prescribed medication for the
symptomatic relief of benign prostatic hyperplasia (BPH). The association of IFIS with other systemic
alpha-1 antagonists such as doxazosin, terazosin, and alfuzosin has since been documented as well4
.
Clinical Features
Although our original paper described a triad of signs with what we would now call severe IFIS, there is
a wide range of clinical severity seen in clinical practice. In a prospective study of 167 eyes in patients
taking tamsulosin, we classified IFIS as being mild (good dilation; some iris billowing without prolapse
or constriction), moderate (iris billowing with some constriction of a moderately dilated pupil), or severe
(classic triad and poor preoperative dilation)2
. Using this scale the distribution of IFIS severity was -
10% no IFIS, 17% mild IFIS, 30% moderate IFIS, and 43% severe IFIS. The tendency for iris prolapse
often first appears during hydrodissection. Iris billowing may be seen when irrigation from the phaco tip
is introduced, followed shortly thereafter by iris prolapse to both the incision and side port paracentesis.
Progressive intraoperative pupil constriction may occur with our without accompanying iris prolapse.
The combination of progressive miosis and iris floppiness increases the likelihood of aspirating the iris
with the phaco tip.
When surgeons have not recognized or anticipated IFIS, the rate of reported intraoperative
complications has been increased. Multiple retrospective studies have published higher rates of capsular
rupture and vitreous loss1, 4-7
. Complications of iris prolapse or aspiration include iridodialysis, iris
sphincter damage, hyphema, and significant iris stromal or transillumination defects. Such iris trauma
can cause permanent pupil deformity with glare or photophobia. In 2009, a retrospective Canadian study
of nearly 100,000 male cataract surgeries documented a doubling of the rate of serious postoperative
complications including retinal detachment, retained nuclear fragments, and severe inflammation in
tamsulosin patients7
.
One important caution with IFIS is that partial thickness sphincterotomies and manual pupil stretching
are ineffective and can exacerbate iris billowing and prolapse1, 4
. A medical history of systemic alpha-1
antagonist use should alert the cataract surgeon to anticipate IFIS and to consider alternative small pupil
management strategies. Our multicenter, prospective study of 169 consecutive cataract surgeries in
tamsulosin patients attained excellent outcomes with low surgical complications by employing four
specific operative techniques either alone or in combination2
. Using Healon 5 viscomydriasis, iris
retractors, preoperative topical atropine administration, or pupil expansion rings, the incidence of
posterior capsule rupture and vitreous loss was less than 1% in this clinical trial. However, because these
2
were highly experienced cataract surgeons, this study may not be representative of the general surgical
experience with IFIS. In a 2008 ASCRS membership survey, 95% of the respondents reported that
tamsulosin increased the difficulty of cataract surgery and 77% believed that it also increased the risk of
complications3
. Specifically, during the prior two years, IFIS had increased the rate of posterior capsular
rupture for 52% of respondents and the rate of significant iris trauma for 23% of the respondents.
Pharmacology and Mechanism of IFIS
Alpha-1 antagonists relax smooth muscle in the bladder neck and prostate. This facilitates more
complete bladder emptying and thereby reduces the lower urinary tract symptoms of benign prostatic
hyperplasia (BPH). There are at least three common human alpha-1 receptor subtypes - alpha-1A, alpha-
1B, and alpha-1D. Doxazosin (Cardura), terazosin (Hytrin), and alfuzosin (Uroxatral) are considered
non-selective alpha-1 antagonists. Tamsulosin, however, is very selective for the alpha-1A receptor
subtype, which predominates in the prostate as well as in the iris dilator smooth muscle. Because it
theoretically should not block the vascular smooth muscle alpha-1D receptors, tamsulosin has a lower
risk of causing postural hypotension. Although BPH is by far the most common indication, both men
and women may take alpha-1 antagonists for other conditions. Tamsulosin is often briefly prescribed as
an adjunctive medication to faciliate renal stone passage following shock wave lithotripsy. It may also
be prescribed for urinary retention in women, and IFIS has been well documented in female patients
taking tamsulosin. Finally, alpha-1 antagonists, such as doxazosin, terazosin, and prazosin, have long
been prescribed for systemic hypertension. Ophthalmologists should also become familiar with two
newer drugs prescribed for BPH symptoms. Silodosin (Rapaflo) is a systemic alpha blocker that was
FDA approved for BPH in 2008. Like tamsulosin, it is also selective for the alpha-1A subtype, and is
similar to tamsulosin in its strong propensity to cause IFIS. Jalyn is the brand name for the combination
of dutasteride and tamsulosin, and was FDA approved in 2010. The combination of these two agents
was shown in a large prospective clinical trial to be more effective at reducing the progression of BPH
compared to either drug alone.
All alpha-1 antagonists may inhibit pupil dilation and cause IFIS. A number of retrospective and
prospective studies, however, have shown that the frequency and severity of IFIS is much higher with
tamsulosin, as compared with non-selective alpha-1 antagonists3-10
. For example, the large retrospective
Canadian study discussed earlier reported that tamsulosin significantly increased the rate of
postoperative complications, but that non-selective alpha antagonists did not7
. A second Canadian
retrospective study found that 86% of patients taking tamsulosin developed IFIS compared to only 15%
of patients taking alfuzosin6
. A prospective masked trial from Italy comparing phaco in patients taking
tamsulosin versus non-selective alpha blockers, and a large 2011 metanalysis of the literature reached
this same conclusion that IFIS is more common and severe with tamsulosin9, 10
. Finally, a large
prospective masked and controlled multicenter clinical study found that severe IFIS was more likely in
patients taking tamsulosin, compared to those taking alfuzosin11
. These and other studies were further
supported by the 2008 ASCRS survey finding that 90 percent of respondents with sufficient experience
believed that IFIS was more common with tamsulosin than with nonselective alpha-1 antagonists3
. IFIS
may also occur in patients without any history of alpha antagonist use. In addition to confirming that
IFIS was strongly correlated with alpha-1 antagonists, one prospective study found that IFIS was also
associated with systemic hypertension in the absence of alpha blockers
3
In our original publication, Campbell and I hypothesized that IFIS was a manifestation of decreased iris
dilator muscle tone and loss of intraoperative structural rigidity1
. Two separate slit lamp OCT studies
have reported significant thinning of the mid iris stromal thickness in tamsulosin patients when
compared to control eyes. Another surprising but widespread finding is that IFIS can occur more than
one year after tamsulosin has been discontinued1-4
. Ninety-five percent of ASCRS survey respondents
have experienced IFIS in patients with only a prior history of alpha-1 antagonist use3
. Tamsulosin can
even be recovered from aqueous samples taken 1-4 weeks after discontinuing the drug, suggesting that is
has a very prolonged receptor binding time. One morphologic study of iridectomy samples from eyes
demonstrating IFIS showed vacuolar degeneration of iris smooth muscle cells12
. A subsequent large
histopathologic study of autopsy eyes from patients taking tamsulosin (26 eyes) also showed atrophy of
the iris dilator muscle, which was consistent with a permanent drug effect on iris morphology13
. In 2012,
Goseki and co-authors published their in vitro and histologic rabbit studies showing that in addition to
smooth muscle alpha-1 receptors, tamsulosin also binds strongly to pigment granules in the iris. Pigment
epithelial cells share nuclei with the adjacent smooth muscle cells, and this unique morphology may
explain the histopathologic finding of dilator muscle atrophy in tamsulosin treated rabbits. Clearly,
cataract surgical patients should be questioned about any prior alpha-1 antagonist use for this reason.
In conclusion, the mechanism of IFIS is not fully understood. There are several anecdotal reports of IFIS
occurring within days of initiating tamsulosin treatment, meaning that chronic drug use is not necessary
to cause this syndrome. However, the stronger association with tamsulosin compared to non-selective
alpha-1 antagonists and the occurrence of IFIS without any prior alpha blocker use suggests a more
complex mechanism than that simply mediated by blockade of the alpha-1A receptor. IFIS appears to
result from a combination of pharmacologic inhibition of iris smooth muscle contraction, and longer
term smooth muscle degeneration relating to drug accumulation in adjacent iris pigment epithelial
cells14
. These permanent structural changes would explain the occurrence of IFIS long after tamsulosin
cessation. A stronger binding affinity to iris pigment granules and alpha-1A receptors might explain the
greater propensity for tamsulosin to cause IFIS compared to non-selective alpha antagonists. Finally,
the strong affinity for some systemic medications, such as psychotropic drugs, to bind to iris pigment
granules might explain the occasional occurrence of IFIS in patients who have never taken alpha
antagonists.
Clinical and surgical management of IFIS
Preoperative management
The possibility of IFIS increases the importance of taking the patient’s medication history prior to
cataract surgery. A history of systemic alpha antagonists may not be elicited without direct questioning
about current or prior use of prostate medication3
.
As discussed earlier, stopping tamsulosin preoperatively is of unpredictable and questionable value.
With so many reported cases of IFIS occurring up to several years after the drug had been stopped, it is
clear that ophthalmologists cannot rely solely upon drug cessation to prevent this condition. In the
multicenter prospective trial mentioned earlier, tamsulosin was discontinued prior to surgery in 19% of
patients, but did not result in any significant reduction in IFIS severity in this subgroup of eyes2
. In the
2008 ASCRS IFIS survey, 64% of respondents said that they never stop tamsulosin prior to surgery,
compared to 11% who routinely do3
.
4
Preoperative atropine drops (e.g., 1% t.i.d. for 1-2 days preoperatively) can enhance cycloplegia as a
means of preventing intraoperative miosis15
. However, the multicenter prospective tamsulosin study
demonstrated that atropine, as a single strategy, is often ineffective for more severe cases of IFIS2
. In the
ASCRS IFIS survey, 57% of respondents said that they never use topical atropine prior to surgery,
compared to 19% who routinely do3
.
Surgical management
The inter-individual variability in the severity of IFIS makes it difficult to determine whether one
surgical strategy is superior to another. The severity of IFIS is likely to be greater in patients taking
tamsulosin. Poor preoperative pupil dilation and billowing of the iris immediately following instillation
of intracameral lidocaine are also predictive of greater IFIS severity2, 4, 9
. In contrast, if the pupil dilates
well preoperatively, mild to moderate IFIS is more likely but the surgeon should still be prepared for iris
prolapse and miosis. Patients taking non-selective alpha-1 antagonists or who have already discontinued
these medications for several months are most likely to display mild to moderate IFIS.
Ideally, surgeons should be facile with several different approaches that may used alone or in
combination to manage the iris in IFIS. In general, one should make a constructed shelved clear corneal
incision, perform hydrodissection very gently, and consider reducing the irrigation and aspiration flow
parameters if possible. Partial thickness sphincterotomies and mechanical pupil stretching, are
ineffective for IFIS and may worsen the iris prolapse and miosis1, 4
.
Intracameral alpha agonists
Intracameral injection of alpha agonists such as phenylephrine or epinephrine, as first reported by
Richard Packard and Joel Shugar respectively, is both a safe and inexpensive strategy for IFIS. By
presumably saturating the alpha 1-A receptors, these agonists can further dilate the pupil. It may take a
minute before the pupil slowly dilates further, but even if it does not, the alpha agonist will often
increase iris dilator muscle tone, reducing billowing and the tendency for prolapse or sudden miosis.
Because of the variable severity of IFIS intracameral alpha agonists work well in some eyes but may
have no detectable effect in others16-19, 4
.
In the United States, 1:1000 epinephrine has been commercially available from several manufacturers.
The 30 ml bottle contains the preservative chlorobutanol and should not be used in the eye. Preservative-
free 1:1000 epinephrine is packaged in single use 1 ml vials (1 mg/ml) and comes in two forms - with
and without 0.1% bisulfite as a stabilizing agent. Bisulfite improves the stability of the solution by
delaying oxidation of the active substance, but is toxic to the corneal endothelium due to its high buffer
capacity. In addition, epinephrine taken directly from the vial has a low pH of approximately 3.0.
Therefore, direct intracameral injection of undiluted 1:1000 epinephrine should be avoided. Instead, a
1:4000 epinephrine solution can be easily constituted by adding 0.2 mL of commercially available
1:1000 epinephrine to 0.6 mL of plain balanced salt solution (BSS) or BSS Plus in a 3-mL disposable
syringe. This dilution raises the pH to a physiologic level and appears to sufficiently dilute the bisulfite
stabilizing agent.
Although bisulfite-free 1:1000 epinephrine (American Regent) is theoretically preferred for intracameral
injection, there has been a nationwide shortage in the United States. The 1:4 dilution of bisulfite-
5
containing epinephrine has been safely used by the author, and was endorsed in a 2013 ASCRS clinical
alert whenever bisulfite-free epinephrine is unavailable. Adding bisulfite-containing epinephrine to a
500 ml BSS irrigation bottle (off label) will not cause corneal endothelial toxicity because of the
significant dilution. However, shortages of even bisulfite-containing 1:1000 epinephrine are now being
reported in the United States. The author has noted an increased incidence of IFIS despite the absence of
systemic alpha antagonists whenever epinephrine is omitted from the BSS irrigation bottle.
Several publications report the safety and efficacy of unpreserved 1.5% intracameral phenylephrine for
both IFIS prevention and routine surgical mydriasis 17-19
. One of these studies found no significant
reduction in endothelial cell counts compared to non-treated eyes.19
Preservative-free phenylephrine
2.5% (Minims) is only commercially available outside the United States. Because these preparations still
contain bisulfite, a 1:4 dilution with BSS, BSS Plus, or preservative-free lidocaine is also recommended.
Lacking a commercial source in the United States, many surgeons (including the author) obtain
bisulfite-free intracameral phenylephrine 1.5% prepared by compounding pharmacies. To avoid
potential toxicity from preservative-containing phenylephrine, ophthalmologists should specify that only
the unpreserved (raw) drug should be used as a compounding source. Prudent precautions for any drug
compounded for intracameral injection include appropriate testing for pH, osmolality, and sterility.
Ophthalmologists should check to see if the compounding pharmacy is accredited by the Pharmacy
Compounding Accreditation Board (PCAB).
When bisulfite-free epinephrine became unavailable, many surgeons questioned whether adding
epinephrine to the BSS irrigating solution was actually necessary. A 2014 study subsequently reported
that omitting epinephrine from the irrigating solution was associated with a 12-13% rate of moderate to
severe IFIS in patients who had previously never taken any systemic alpha antagonists11
. Omidria
(Omeros) received FDA approval in 2014. This commercial combination of phenylephrine and ketorolac
is added to the irrigation solution.
As first suggested by Bob Osher and Doug Koch, Healon 5 (Abbott Medical Optics) is a maximally
cohesive ophthalmic visco-surgical device (OVD) that is particularly well suited for viscomydriasis and
for blocking iris prolapse in IFIS. If mydriasis is still suboptimal after injecting epinephrine, Healon 5
can then be used to further mechanically expand the pupil. Viscomydriasis facilitates the capsulorhexis
and combines with the epinephrine-induced iris rigidity to block iris prolapse. However, to avoid
immediately aspirating Healon 5 one must employ low flow and vacuum parameters (e.g. < 175-200
mmHg; < 26 ml/min). This strategy is therefore less suitable if high vacuum settings are desired for
denser nuclei. At higher aspiration flow rates, others have suggested that more dispersive OVDs, such as
DisCoVisc (Alcon) or Viscoat (Alcon), may persist for longer periods within the eye. Finally,
combining Healon 5 with Viscoat has been advocated as a combination strategy whereby the Viscoat
will better resist aspiration and delay the evacuation of Healon 520
.
Mechanical pupil expansion with iris retractors or devices such as the Malyugin ring assures a reliably
wide pupil diameter that cannot abruptly constrict during surgery21
. Mechanical devices also permit
surgeons to use their preferred OVD, phaco technique, and fluidic parameters. It is easier and safer to
insert these devices prior to creation of the capsulorrhexis. If the pupil dilates poorly preoperatively (e.g.
3 – 5 mm diameter), or billows during injection of intracameral lidocaine, one should consider
proceeding directly to mechanical devices because of the likelihood of severe IFIS. If the pupil dilates
6
well preoperatively, but begins to constrict or prolapse after hydrodissection or during phaco combining
intracameral epinephrine and Healon 5 can be an excellent rescue technique that may avoid the need to
insert mechanical devices. If iris retractors are used, one should retract the pupil margin with a second
instrument to avoid hooking the capsulorrhexis margin with the retractors.
Pupil Expansion Rings
Pupil expansion rings are disposable devices that mechanically expand and maintain the intraoperative
pupil diameter. Disposable PMMA rings, such as the Morcher 5S Pupil Ring and the Milvella Perfect
Pupil, have grooved contours are threaded alongside the pupillary margin with dedicated metal injectors.
Eagle Vision’s Graether disposable silicone pupil expansion ring is inserted with a single use plastic
injector. All of these rings are relatively difficult to position if the pupil is less than 4 mm wide or if the
anterior chamber is shallow. They will fail to engage the iris if the pupil diameter is larger than 7 mm.
Most surgeons find the Malyugin ring (Microsurgical technologies, Redmond WA) to be the easiest and
fastest pupil expansion device to insert and remove21
. This is a 5-0 polypropylene single use device that
is introduced with a disposable injector. The way in which the iris drapes over the sides of the device
creates a round 6 mm or 7 mm pupil diameter, depending on which of the two available sizes is used.
The disposable injector tip fits through a 2.5 mm incision and is used to both place and extract the ring.
Compared to bulkier and rigid plastic expansion rings, the thin profile of the Malyugin ring reduces the
risk of accidental corneal or incisional trauma and does not impede instrument access to the cataract.
The avoidance of multiple paracentesis sites, is advantageous in the presence of a bleb, a pterygium, and
multiple RK scars, and avoids the problem of iris hooks being pushed against the lid speculum with a
tight palpebral fissure. Finally, the smooth coils are very gentle on the pupil margin, and generally
minimize iris sphincter damage. A similar iris expander device has been introduced by Oasis Medical.
Iris Retractors
The author prefers reusable 4–0 polypropylene retractors (available from Katena Products, Inc.,
Denville, NJ, and FCI Ophthalmics, Inc., Marshfield Hills, MA) to disposable 6–0 nylon retractors
(available from Alcon Laboratories, Inc., Fort Worth, TX). Measuring 0.15mm in diameter, the 4–0
retractors are the same size and stiffness as the polypropylene haptic of an IOL. This greater rigidity,
when compared to 6–0 nylon retractors, makes 4–0 retractors more durable and easier to manipulate.
Furthermore, the 4-0 polypropylene hooks can be repeatedly autoclaved in the manufacturer supplied
storage case, which makes them more cost effective than disposable hooks or pupil expansion rings.
Before initiating the capsulorrhexis, 1-mm limbal paracenteses are created in each quadrant, including a
separate stab incision just posterior to the temporal clear corneal incision. In this way, the phaco tip
passes through a separate incision directly alongside and above the track for the subincisional retractor.
As originally advocated by Oetting and Omphroy, placing the hooks in this diamond configuration has
several advantages. The subincisional hook retracts the iris downward and out of the path of the phaco
tip. This not only provides excellent access to subincisional cortex, but also avoids tenting the iris up in
front of the phaco tip, such as occurs when the retractors are placed in a square configuration. This
configuration also maximizes temporal exposure directly in front of the phaco tip as well as nasal
exposure for placement of the chopper tip. Following IOL implantation, the iris retractors are removed,
7
rinsed in balanced salt solution, and gently dabbed with an instrument wipe to remove any viscoelastic
residue. They are then stored in the autoclavable storage container.
Iris retractors both enlarge and maintain an adequate pupillary size throughout the course of surgery.
They provide sufficient tension to the iris stroma so that no prolapse can occur with IFIS. If the pupil is
fibrotic, such as with chronic pilocarpine use or longstanding posterior synechiae, overstretching the iris
can cause bleeding, tear the sphincter, and result in permanent mydriasis. It is therefore advisable to start
with a smaller target diameter than needed with the expectation that the pupil opening will widen further
during phaco. The likely reason for this is that the hydrostatic irrigation force propels the iris posteriorly
against the four-point restraints of the anchored retractors. This effectively acts to mechanically stretch
the pupil margin resulting in microscopic sphincter muscle tears. The exception is the IFIS pupil, which
tends to be elastic and stretches maximally without tearing. Maximal widening with iris retractors can be
employed with IFIS eyes.
Eliciting a history of current or prior alpha-1 antagonist use should alert surgeons to anticipate IFIS and
to employ these strategies either alone or in combination. Because of the variability in IFIS severity,
many surgeons use a staged management approach4, 18
. Pharmacologic measures alone may be sufficient
for mild to moderate IFIS cases. Even if they fail to enlarge the pupil, intracameral alpha agonists can
reduce or prevent iris billowing and prolapse by increasing iris dilator muscle tone. If the pupil diameter
is still inadequate, viscomydriasis with Healon 5 can further expand it for the capsulorrhexis step.
Finally, mechanical expansion devices assure the best surgical exposure for severe IFIS, and should be
considered when other risk factors, such as weak zonules or a brunescent nucleus are present.
References:
1. Chang DF, Campbell JR. Intraoperative floppy iris syndrome associated with tamsulosin (Flomax). J Cataract
Refract Surg 2005; 31: 664-673.
2. Chang DF, Osher RH, Wang L, Koch DD. Prospective multicenter evaluation of cataract surgery in patients taking tamsulosin
(Flomax). Ophthalmology 2007;114:957-964.
3. Chang DF, Braga-Mele R, Mamalis N, et al., for the ASCRS Cataract Clinical Committee. Clinical experience with
intraoperative floppy-iris syndrome. Results of the 2008 ASCRS member survey. J Cataract Refract Surg. 2008;34:1201-
1209.
4. Chang DF, Braga Mele R, Mamalis N, et al. for the ASCRS Cataract Clinical Committee. ASCRS White Paper:
Intraoperative Floppy Iris Syndrome – A Clinical Review. J Cataract Refract Surg 2008;34:2153-2162.
5. Chadha V, Borooah S, Tey A, et al. Floppy iris behaviour during cataract surgery: associations and variations. Br
J Ophthalmol. 2007; 91:40-42.
6. Blouin M, Blouin J, Perreault S, et al. Intraoperative floppy iris syndrome associated with Alpha-1
adrenoreceptors. Comparison of tamsulosin and alfuzosin. J Cataract Refract Surg 2007; 33:1227-1234.
7. Bell CM, Hatch WV, Fischer HD, Cernat G, Paterson JM, Gruneir A, Gill SS, Bronskill SE, Anderson GM, Rochon
PA. Association between tamsulosin and serious ophthalmic adverse events in older men following cataract surgery.
JAMA 2009; 301:1991-1996.
8. Palea S, Chang DF, Rekik M, et al. Comparative effect of alfuzosin and tamsulosin on the contractile response of
isolated rabbit prostatic and iris dilator smooth muscles. Possible model for intraoperative floppy iris syndrome. J
Cataract Refract Surg 2008; 34: 489-496.
9. Chatziralli IP, Sergentanis TN. Risk factors for intraoperative floppy iris syndrome: a meta-analysis. Ophthalmology
2011;118:730-735.
10. Casuccio A, Cillino G, Pavone C, et. al. Pharmacologic pupil dilation as a predictive test for the risk of
intraoperative floppy-iris syndrome. J Cataract Refract Surg 2011;37: 1447-1454.
8
11. Chang DF, Campbell JR, Colin J, Schweitzer C. Prospective masked comparison of intraoperative floppy iris syndrome
severity with tamsulosin versus alfuzosin. Ophthalmology 2014;121:829-834
12. Goseki T, Shimizu K, Ishikawa H, Nishimoto H, Uga S, Nemoto N, Patil PN. Possible mechanism of intraoperative
floppy iris syndrome: a clinicopathological study. Br J Ophthalmol. 2008; 92: 1156-1158
13. Santaella RM, Destafeno JJ, Stinnett SS, et al. The effect of alpha1-adrenergic receptor antagonist tamsulosin
(Flomax) on iris dilator smooth muscle anatomy. Ophthalmology. 2010;117:1743-1749.
14. Goseki T, Ishikawa H, Ogasawara S, et al. Effects of tamsulosin and silodisin on isolated albina and pigmented
rabbit iris dilators – Possible mechanism of IFIS. J Cataract Refract Surg 2012;38: 1643-1649.
15. Masket S, Belani S. Combined preoperative topical atropine sulfate 1% and intracameral nonpreserved
epinephrine hydrochloride 1:4000 [corrected] for management of intraoperative floppy-iris syndrome. J Cataract
Refract Surg. 2007; 33:580-582.
16. Shugar, JK. Intracameral Epinephrine for Prophylaxis of IFIS [letter]. J Cataract Refract Surg 2006; 32: 1074-
1075.
17. Gurbaxani A, Packard R. Intracameral phenylephrine to prevent floppy iris syndrome during cataract surgery in
patients on tamsulosin. Eye. 2007; 21:331-332.
18. Manvikar S, Allen D. Cataract surgery management in patients taking tamsulosin. J Cataract Refract Surg 2006; 32:
1611-1614
19. Lorente R, de Rojas V, Vázquez de Parga P, et al. Intracameral Phenylephrine 1.5% for Prophylaxis against
Intraoperative Floppy Iris Syndrome: Prospective, Randomized Fellow Eye Study. Ophthalmology. 2012 Jun 16.
[Epub ahead of print]
20. Arshinoff SA. Modified SST-USST for tamsulosin-associated intraocular floppy iris syndrome. J Cataract Refract
Surg 2006; 32: 559-561.
21.Chang DF. Use of Malyugin pupil expansion device for intraoperative floppy iris syndrome: Results in 30
consecutive cases. J Cataract Refract Surg 2008;34:835-841.
9
Intraoperative Floppy Iris Syndrome Associated with Systemic Alpha-1 Antagonists
2014 ASCRS and AAO Educational Update Statement for Prescribing MDs
In 2005 the U.S. Food and Drug Administration issued a new label warning about the association of α1-
antagonists and intraoperative floppy iris syndrome (IFIS). Characterized by sudden intraoperative iris
prolapse and pupil constriction, IFIS increases both the difficulty and the risk of cataract surgery1
. Some
complications of IFIS have been sight threatening, including retinal detachment, lost lens fragments,
endophthalmitis, and severe iris defects associated with permanent pupil deformity, glare, and
photophobia1-3
. Tamsulosin is the most commonly prescribed α1-antagonist for benign prostate
hyperplasia (BPH) in North America. Until the approval of silodosin, tamsulosin was the only systemic
α1-antagonist that is selective for the α1-A receptor subtype that predominates in the prostate. Because
vascular smooth muscle receptors are α1-B, the theoretical advantage of such receptor subtype
selectivity is reduced risk of postural hypotension. Although initial blood pressure monitoring may be
recommended when prescribing older non-selective α1-antagonists, such as terazosin and doxazosin,
another non-selective α1-antagonist, alfuzosin, rarely causes postural hypotension and is associated with
fewer cardiovascular adverse events 4-6
.
It is well recognized that simply discontinuing oral α1-antagonists does not prevent IFIS1
. Studies of
rabbit and human cadaver eyes have shown that tamsulosin is associated with atrophy of the iris dilator
smooth muscle, and that this may be due to concentration of the drug in iris pigment granules7,8
. In
2008, the American Society of Cataract and Refractive Surgery (ASCRS) and the American Academy
of Ophthalmology (AAO) jointly issued an educational update advisory on IFIS asking prescribing
physicians to consider involving the cataract surgeon prior to initially prescribing non-emergent, chronic
α1-antagonists in patients with known cataracts. Prescribing physicians were also asked to encourage
patients to report any prior or current history of α1-antagonist use to their ophthalmic surgeon prior to
undergoing any eye surgery.
Since the 2008 advisory statement, additional evidence has emerged showing that severe IFIS is more
likely to occur with tamsulosin compared to non-selective α1-antagonists. A 2011 meta-analysis of 17
published studies found that tamsulosin had a 40-fold higher pooled odds ratio for IFIS compared to
alfuzosin and terazosin9
. A subsequent prospective, masked single surgeon study found severe IFIS
more commonly with tamsulosin compared to non-selective α1-antagonists as a group10
. Finally, a
newly published multicenter prospective study found that severe IFIS was statistically more likely with
tamsulosin than alfuzosin11
. This was the first prospective, masked and controlled study to specifically
compare two α1-antagonists with a low reported incidence of cardiovascular adverse events. In a 2008
survey, nearly two thirds of ophthalmologists said that if they themselves had a mildly symptomatic
cataract they would either avoid tamsulosin or have their cataract removed first 12
.
A newly published survey of primary care physicians from the University of California, San Francisco
showed that only 35% were aware that α1-antagonists can cause cataract surgical complications; only
half (17%) factored this into treatment considerations13
. Less than 10% inquire about a history of
cataract prior to initiating α1-antagonist treatment and only 31% regularly advise patients to inform their
ophthalmologist about taking these drugs. Most respondents (96%) desired more information on this
topic.
10
We are issuing this updated educational statement for prescribing physicians based on these two newly
published reports. Patients with symptomatic cataracts may wish to consider cataract surgery prior to
initiating non-emergent α1-antagonist therapy. Because tamsulosin is associated with the highest risk of
IFIS, patients with cataracts may wish to consider a non-selective α1-antagonist as initial treatment.
References:
1. Chang DF, Braga-Mele R, Mamalis N, et al. ASCRS white paper: clinical review of intraoperative floppy-iris
syndrome. J Cataract Refract Surg 2008;34:2153-2162.
2. Bell CM, Hatch WW, Fischer HD, et al. Association between tamsulosin and serious ophthalmic adverse events
in older men following cataract surgery. JAMA 2009;301(19):1991-1996.
3. Chang DF. Floppy Iris Syndrome: Why BPH can complicate cataract surgery. Am Fam Physician 2009; 79:
1051, 1055-1056.
4. McVary KT, Roehrborn CG, Avins AL, et al. Update on AUA guideline on the management of benign prostatic
hyperplasia. J Urol 2011; 185:1793-1803.
5. Buzelin JM, Delauche-Cavallier MD, Roth S, et al. Clinical uroselectivity: evidence from patients treated with
slow-release alfuzosin for symptomatic benign prostatic obstruction. Br Journal Urol 1997;79:898-906.
6. Roehrborn CG. Alfuzosin: overview of pharmacokinetics, safety, and efficacy of a clinically uroselective alpha-
blocker. Urology 2001;58:55-63.
7. Santaella RM, Destafeno JJ, Stinnett SS, et al. The effect of alpha1-adrenergic receptor antagonist tamsulosin
(Flomax) on iris dilator smooth muscle anatomy. Ophthalmology 2010;117:1743-1749.
8. Goseki T, Ishikawa H, Ogasawara S, et al. Effects of tamsulosin and silodisin on isolated albina and pigmented
rabbit iris dilators – Possible mechanism of IFIS. J Cataract Refract Surg 2012;38: 1643-1649.
9. Chatziralli IP, Sergentanis TN. Risk Factors for intraoperative floppy iris syndrome: A meta-analysis.
Ophthalmology 2011; 118:730-735.
10. Casuccio A, Cillino G, Pavone C, et al. Pharmacologic pupil dilation as a predictive test for the risk of
intraoperative floppy-iris syndrome. J Cataract Refract Surg 2011;37: 1447-1454.
11. Chang DF, Campbell JR, Colin J, Schweitzer C. Prospective masked comparison of intraoperative floppy iris syndrome
severity with tamsulosin versus alfuzosin. Ophthalmology 2014;121:829-834
12. Chang DF, Braga-Mele R, Mamalis N, et al., for the ASCRS Cataract Clinical Committee. Clinical experience with
intraoperative floppy-iris syndrome. Results of the 2008 ASCRS member survey. J Cataract Refract Surg. 2008;34:1201-
1209.
13. Doss EL, Potter MB, Chang DF. Primary Care Physicians Still Lack Awareness of IFIS. J Cataract Refract Surg
2014;40: 685-686
11
New studies on IFIS prompt ASCRS/AAO Educational Update for Prescribing Physicians
(EyeWorld, April 2014) David F. Chang MD
Two new studies on intraoperative floppy iris syndrome (IFIS) that I was involved with will be
published this month, and they have prompted a renewed joint effort by ASCRS and AAO to educate
prescribing physicians about the potential adverse effects of systemic α1-antagonists on cataract surgery.
The first study (Chang DF, Campbell JR, Colin J, Schweitzer C. Prospective masked comparison of
intraoperative floppy iris syndrome severity with tamsulosin versus alfuzosin. Ophthalmology 2014;121
(April):829-834) adds to the mounting evidence that tamsulosin creates a higher risk of severe IFIS,
compared to non-selective α1-antagonists.
Of the α1 receptor sub-types, the α1A receptor predominates in both the iris dilator and prostatic smooth
muscle. Among α1-antagonists prescribed for benign prostatic hyperplasia (BPH), only tamsulosin and
silodosin are sub-type selective and demonstrate the highest affinity for the α1A-receptor. Such receptor
uroselectivity reduces the risk of postural hypotension due to blockade of the α1B receptors in vascular
smooth muscle. All of the α1-antagonists can impair pupil dilation and cause IFIS. However, a number
of prospective and retrospective studies have suggested that the frequency and severity of IFIS is greater
in patients taking tamsulosin compared to the non-selective α1-antagonists, such as terazosin, doxazosin,
and alfuzosin1, 2
. A 2011 meta-analysis of 17 published studies reported that tamsulosin had a 40-fold
higher pooled odds ratio for IFIS compared to alfuzosin and terazosin2
. In vitro experiments
demonstrated that tamsulosin is a much stronger antagonist of rabbit iris dilator muscle contraction than
alfuzosin3
. Finally, a 2008 survey of ASCRS members indicated that 90% of respondents (with enough
personal experience) felt that IFIS was more common with tamsulosin than with non-selective α1-
antagonists4
.
Because many of the prior studies were retrospective and were not masked, my co-investigators and I
decided to conduct a multicenter prospective, masked, controlled comparison of tamsulosin and
alfuzosin - the two α1-antagonists with the fewest reported cardiovascular adverse events. Undoubtedly
one of the reasons that tamulosin became the most prescribed treatment for BPH was its theoretical
uroselectivity and reduced incidence of postural hypotension. Although it is a non-selective α1-
antagonist, alfuzosin is often referred to as “clinically uroselective”. The reduction in postural
hypotension with alfuzosin is not due to receptor specificity, but rather to pill reformulation to slow
release of the molecule in the GI tract.
The study was conducted in France, where alfuzosin is more commonly prescribed than in most other
countries. Sanofi Aventis, the manufacturer of alfuzosin (Uroxatral) is a French pharmaceutical
company. Eight study surgeons from four sites enrolled 113 consecutive patients taking either
tamsulosin or alfuzosin. Each time a study patient was enrolled, a control patient with no prior history of
α1-antagonist use was enrolled by the same cataract surgeon on the same day. All 226 cases were
videotaped and two masked ophthalmologists (John Campbell and myself) then graded every video for
the presence and severity of IFIS. Severe IFIS—defined as iris billowing and prolapse with ≥ 2 mm of
pupil constriction— was more common with either α1-antagonist compared to control eyes. However,
severe IFIS was noted in 34.3 percent (24/70) of the tamsulosin eyes and 16.3 percent (7/43) of the
alfuzosin eyes (P< 0.05). Therefore, if an α1-antagonist with a lower risk of cardiovascular side effects
is indicated, patients with cataracts may want to try alfuzosin first.
12
Unfortunately for cataract surgeons, tamsulosin continues to be the most frequently prescribed
medication for BPH, and its use will surely rise now that it is generic in the United States. As an
alternative to α1-antagonists, 5-α reductase inhibitors (dutasteride and finasteride) are also effective and
approved as medical monotherapy of BPH. However, a large multinational randomized trial
demonstrated that the combination of dutasteride and tamsulosin was superior to either drug alone in the
prevention of BPH progression. Ophthalmologists must therefore recognize that Jalyn is the brand name
for this specific drug combination. Finally silodosin (Rapaflo) is the most recent α1-antagonist to be
approved for BPH and most resembles tamsulosin in its α1A receptor sub-type specificity.
The second study (Doss EL, Potter MB, Chang DF. Primary Care Physicians Still Lack Awareness of
IFIS. J Cataract Refract Surg 2014;40 (April): 685-686) was a survey of primary care physicians from
the University of California, San Francisco (UCSF) designed to assess their α1-antagonist prescribing
patterns and their awareness of IFIS. A brief questionnaire was emailed to 350 health care providers in
the UCSF Collaborative Research Network and 133 responded. Forty percent initiate BPH medical
treatment at least twice a month. Overall, only 35% were aware that α1-antagonists can cause cataract
surgical complications; only half (17%) factored this into treatment considerations. Less than 10%
inquire about a history of cataract prior to initiating α1-antagonist treatment and only 31% regularly
advise patients to inform their ophthalmologist about taking these drugs. Most respondents (96%)
desired more information on this topic.
Based on the new information from these two studies, the ASCRS Cataract Clinical Committee decided
that a renewed effort to educate prescribing physicians treating BPH should be initiated. We have
collaborated with the AAO in writing a joint educational document that was formally issued in early
April. This new document updates the 2008 joint ASCRS/AAO IFIS educational statement which asked
1) prescribing physicians to consider involving the ophthalmologist prior to initiating α1-antagonists in
patients with known cataracts and 2) reminding patients taking systemic α1-antagonists to report this
medication history prior to having any eye surgery. The newly issued educational statement states,
“Patients with symptomatic cataracts may wish to consider cataract surgery prior to initiating non-
emergent α1-antagonist therapy. Because tamsulosin is associated with the highest risk of IFIS,
patients with cataracts may wish to consider a non-selective α1-antagonist as initial treatment”. We
have communicated with the American Academy of Family Physicians, the American College of
Physicians, and the American Urological Association who will each help to disseminate this information
to their respective memberships. In addition, this document is a concise, referenced summary that
ophthalmologists can share with prescribing doctors in their communities on an individual basis. It can
be downloaded from the ASCRS web site www.ascrs.org
1. Chang DF, Braga-Mele R, Mamalis N, et al. ASCRS white paper: clinical review of intraoperative floppy-iris
syndrome. J Cataract Refract Surg 2008;34:2153-2162.
2. Chatziralli IP, Sergentanis TN. Risk Factors for intraoperative floppy iris syndrome: A meta-analysis. Ophthalmology
2011; 118:730-735.
3. Palea S, Chang DF, Rekik M, et al. Comparative effect of alfuzosin and tamsulosin on the contractile response of
isolated rabbit prostatic and iris dilator smooth muscles. Possible model for intraoperative floppy iris syndrome. J
Cataract Refract Surg 2008; 34: 489-496.
4. Chang DF, Braga-mele R, Mamalis N, et al. Clinical experience with intraoperative floppy-iris syndrome. Results of
the 2008 ASCRS member survey. J Cataract Refract Surg 2008; 34:1201-1209.
Steve A Arshinoff MD FRCSC OVD Stepladder Approach to IFIS AAO 2014
1
Managing Flomax IFIS (with OVDs*)
A Step Ladder Approach
*Arshinoff Steve A. Modified SST-USST for
tamsulosin-associated intraocular floppy-iris
syndrome. JCRS 2006; 32: 559-561. April.
Course 418
Oct. 20, 2014
Incision
1. Viscoat
filled space
(injected 1st)
2. Viscoadaptive
filled space
(injected 2nd)
3. BSS
filled space
(injected 3rd)
I F I S S S B r i d g e
Steve A. Arshinoff MD FRCSC
Eye Associates, Humber River Hospital
University of Toronto, Toronto, ON, Canada
McMaster University, Hamilton, ON, Canada
Financial Disclosures:
Alcon Laboratories Inc. - C
Abbott Medical Optics - C
Bausch & Lomb – C
Anteis – C
iMed Pharma - C
Arctic Dx. - C
Two physical components of Phaco:
Phaco power modulations
Rheology
= Control of flow in, & maintenance of,
the AC.
OVDs are pseudoplastic fluids used to create an AC surgical
environment optimized for surgery.
Creative use of OVDs reduces complication rates.
“Phaco is Rheology”
TSST
Arshinoff SA, Norman R. JCRS 2013; 39: 1196-1203.
Tri-Soft Shell Technique (TSST)
logical system of unification of soft
shell techniques to make them easier
to understand & perform.
Successfully	
  Managing	
  IFIS	
  with	
  OVDs	
  
—  Step	
  1:	
   	
  Study	
  the	
  eye	
  &	
  warn	
  pa=ent.	
  	
  
	
   	
  Perform	
  preop	
  dila=on	
  test.	
  
	
  
—  Step	
  2: 	
  Prepare	
  the	
  AC.	
  
	
  
—  Step	
  3: 	
  Create	
  	
  IFIS	
  SoF	
  Shell	
  Bridge	
  	
  	
  (SSB)	
  
	
  	
  	
  	
  
—  Step	
  4: 	
  Perform	
  low	
  flow,	
  low	
  turbulence	
  surgery.	
  
	
  
—  Step	
  5: 	
  Malyugin	
  Ring	
  	
  	
  (or	
  iris	
  retractors)	
  rarely	
  needed	
  
Steve A Arshinoff MD FRCSC OVD Stepladder Approach to IFIS AAO 2014
2
Successfully	
  Managing	
  IFIS	
  with	
  OVDs	
  
—  Step	
  1:	
   	
  Study	
  the	
  eye	
  &	
  warn	
  pa=ent.	
  	
  
	
   	
  Perform	
  preop	
  dila=on	
  test.	
  
	
  
—  Step	
  2: 	
  Prepare	
  the	
  AC.	
  
	
  
—  Step	
  3: 	
  Create	
  	
  IFIS	
  SoF	
  Shell	
  Bridge	
  	
  	
  (SSB)	
  
	
  	
  	
  	
  
—  Step	
  4: 	
  Perform	
  low	
  flow,	
  low	
  turbulence	
  surgery.	
  
	
  
—  Step	
  5: 	
  Malyugin	
  Ring	
  	
  	
  (or	
  iris	
  retractors)	
  rarely	
  needed	
  
Warn	
  	
  Flomax	
  	
  pts:	
  
	
  
Flomax	
  pa=ents	
  are	
  asked	
  to	
  
have	
  their	
  doctor	
  change	
  them	
  
to	
  a	
  different	
  BPH	
  α	
  blocker	
  	
  
before	
  surgery.	
  
	
  
(	
  This	
  may	
  not	
  make	
  much	
  difference.	
  )	
  
Step	
  1:	
  	
  Carefully	
  examine	
  iris	
  &	
  pupil	
  
—  See	
  all	
  small	
  pupil	
  cases	
  ≤	
  2	
  weeks	
  preop!	
  
	
  
-­‐	
  Is	
  it	
  IFIS	
  or	
  “pseudo	
  IFIS”?	
  
	
  	
  	
  	
  Iris	
  atrophic?	
  	
  post	
  synechiae?	
  
	
  	
  Fibro=c	
  pupillary	
  ring?	
  
	
  
—  Preop	
  pupil	
  dila=on	
  test:	
  
1.  tropicamide	
  1%	
  gDs	
  x	
  2,	
  
phenylephrine	
  	
  2.5%	
  x	
  1	
  
2.  wait	
  20	
  min:	
  	
  observe	
  …	
  
Flomax	
  effect	
  is	
  variable!!	
  
	
  
Blue	
  eyes	
  much	
  worse	
  than	
  brown.	
  
> 6.5 mm = no problem
- 2x adrenaline in bottle
- intracam. Xylo-phe.
~ 6.0 mm = minor problems
- tight incisions !!
- IFIS Soft Shell Bridge
< 5.5 mm = serious IFIS
- expect trouble.
- ? + Malyugin Ring
no dilation = not likely Flomax
– stretch pupils
Successfully	
  Managing	
  IFIS	
  with	
  OVDs	
  
—  Step	
  1:	
   	
  Study	
  the	
  eye	
  &	
  warn	
  pa=ent.	
  	
  
	
   	
  Perform	
  preop	
  dila=on	
  test.	
  
	
  
—  Step	
  2: 	
  Prepare	
  the	
  AC.	
  
	
  
—  Step	
  3: 	
  Create	
  	
  IFIS	
  SoF	
  Shell	
  Bridge	
  	
  	
  (SSB)	
  
	
  	
  	
  	
  
—  Step	
  4: 	
  Perform	
  low	
  flow,	
  low	
  turbulence	
  surgery.	
  
	
  
—  Step	
  5: 	
  Malyugin	
  Ring	
  	
  	
  (or	
  iris	
  retractors)	
  rarely	
  needed	
  
Steve A Arshinoff MD FRCSC OVD Stepladder Approach to IFIS AAO 2014
3
Step	
  2:	
  	
  Preparing	
  the	
  AC	
  for	
  IFIS	
  
1.  Use	
  IC	
  xylo-­‐phe	
  &	
  2	
  x	
  adrenaline	
  in	
  the	
  boZle.	
  
-­‐	
  1cc.	
  intracardiac	
  1:1,000	
  adrenaline	
  /	
  500	
  cc	
  BSS	
  
	
  
	
  
2.  Long,	
  =ght	
  incisions	
  
	
  -­‐	
  prevent	
  iris	
  prolapse.	
  
*Arshinoff Steve. Cataract Surgery in Compromised Endothelium. In Chakrabarti
A. Cataract Surgery in Diseased Eyes. Jaypee Brothers Ltd., New Delhi. 2013.
*
Intracameral	
  	
  Sympathomime=c	
  	
  Agents	
  
	
  	
  	
  	
  	
  	
  	
  	
  	
  	
  	
  	
  	
  	
  	
   	
   	
  	
  Agent: 	
   	
   	
   	
  Source 	
   	
  “stabilizer”	
  
1.  Irrigant	
  boZle	
  Epinephrine	
  1mg/ml	
  	
   	
   	
  Hospira 	
  	
  	
  	
  	
  	
  	
  	
  	
  	
  	
   	
  metabisulfite
	
  -­‐	
  1:500	
  dilu=on	
  in	
  irrigant	
  BSS	
  
2.  *Non-­‐preserved	
  Epi	
  injec=on,	
  USP	
  1:1,000	
  American	
  Regent	
   	
  	
  	
  	
  	
  	
  none	
  
1	
  ml	
  ampules:	
  **dilute	
  1:3	
  with	
  BSS	
  –	
  J	
  Shugar	
  
3. 	
   +Phenylephrine	
  10%	
  minims	
  diluted	
  in	
  5	
  cc	
  BSS	
  	
  	
  	
  	
  	
  	
  	
  	
  	
  Chauvin	
  (B&L) 	
  metabisulfite	
  	
  
	
  -­‐	
  1st	
  proposed	
  by	
  David	
  Allen,	
  Richard	
  Packard 	
   	
   	
  	
  Na2EDTA	
  
	
  
	
  
* Slack JW, Edelhauser HF, Helenek MJ. A bisulfite-free intraocular epinephrine solution
** Shugar J. Epinephrine for IFIS prophylaxis. JCRS 2006: 32; 1074-1075
+ Manvikar S, Allen D. cat surg in pts taking tamsulosin. JCRS 2006. 32: 1611-14. Packard R. CRST 2007. May.
Xylocaine –Phenylephrine
to facilitate cataract surgeryINTRACAMERAL MYDRIATICS IN PHACOEMULSIFICATION
The mean corneal endothelial cell loss at 1 month
was 2.3% Ϯ 6.1% in the intracameral group and
4.1% Ϯ 6.0% in the topical group (P ϭ .25) (Table
1). The postoperative cell counts were not significantly
different from the preoperative values (P ϭ .19 and
P ϭ .17, respectively). In contrast, cells were more
irregular and elongated postoperatively in both the in-
tracameral group and the topical group as assessed by
HSF (P ϭ .0092 and P ϭ .0010, respectively) and by
DE (P ϭ .0037 and PϽ.001, respectively); there were
no significant differences between the groups (Table 1).
A significant decrease in pulse rate occurred in the
topical group (P ϭ .0055) but not in the intracameral
group (P ϭ .15). The difference in pulse decelerationFigure 1. (Lundberg) Pupil size (mean Ϯ SD) after injection of intra-
cameral mydriatics (s ϭ seconds). was significant between the groups (Table 1). The
slightly increased postoperative MAP did not differ sig-
nificantly from the preoperative values in either the
sure ϫ 1/3 ϩ diastolic blood pressure ϫ 2/3. Finally, all intracameral group or the topical group (P ϭ .072 and
patients graded their subjective sensation of pain and glare
P ϭ .10, respectively).
during the procedure using a visual analog scale from 0 to 10.
Complications in the intracameral group were 1A binary logistic regression model was used to evaluate
case of slight damage to the capsulorhexis and in thewhether preoperative differences existed between the groups
in BCVA, IOP, pseudoexfoliation, iris color, cataract classifi- topical group, 1 case each of iris prolapse and posterior
cation, corneal endothelial cell count, pupil size, corneal capsule rupture without vitreous loss. Mechanical pupil
thickness, pulse, MAP, age, or sex. There were no significant
dilation was performed in 3 eyes in the intracameral
differences in the preoperative parameters between the 2 groups
group and 1 eye in the topical group.(P ϭ .72). The Mann-Whitney U test was used to evaluate
pain, glare, and cell and flare data, and the Student
2-tailed t test was used for all other statistical comparisons. A
DiscussionP value less than 0.05 was considered statistically significant.
Mean values are given with their standard deviations. This study shows that mydriatics can be safely in-
jected into the anterior chamber before phacoemulsifi-
cation cataract surgery in sufficient doses to allow theResults
Xylo + 0.1% Phe
1st proposed:
Lundberg B, Behndig A.
Intracameral mydriatics in
phacoemulsification cataract
surgery.
JCRS 2003; 29: 2366-71.
used 0.1%phenylephrine
Intracameral Phenylephrine
—  Dose response: Behndig A, Lundberg B.
Mydriatic response to different concentrations
of intracameral phenylephrine in humans.
JCRS 2010; 36:1682-86.
≥ 1.5% phenylephrine yields superior dilation.
—  IFIS: Gurbaxani A, Packard R.
Intracameral phenylephrine to prevent floppy iris
syndrome during cataract surgery in patients on
tamsulosin. Eye 2007; 21: 331-2
Diluted phenylephrine B&L minims 2.5%: Add 0.25 ml + 1 ml BSS è 0.5%
—  Bill Myers (Chicago) – IC phenylephrine obtained from Leiter’s in US.
—  Ramon Lorente (Spain) – 1.5% phenylephrine IC for IFIS. Ophthalmology 2012; 119: 2053-8.
Figure 1. Mean pupil sizes over time after intracameral injection of
0.15 mL phenylephrine at different concentrations
≥ 1.5%
< 1.5%
Phe
Steve A Arshinoff MD FRCSC OVD Stepladder Approach to IFIS AAO 2014
4
IC xylo-phe
1.  Add minim (0.3 cc) 10% phenylephrine to 5 cc BSS in 6 cc
syringe
(è 0.57%, diluted 17.7x).
2.  Add 3-4 drops of above phenylephrine solution to xylocaine (Astra
1% non-preserved insotonic xylo polyamp) on scrub tray (è0.05%,
diluted ≥200x).
3.  Inject 0.1 cc IC xylo-phe thru side port. (1.)
— Almost all pupils dilate to 8-9 mm in 10 seconds.
4.  Inject 0.1 cc IC xylo-phe under OVD. (2.)
— 1 more mm of pupil dilation.
IC xylo-phe: Why it works so well.
—  Xylocaine: Completely paralyzes sphincter.
—  Phenylephrine: Aggressively stimulates dilator.
* Benefits: 1. Maximally enhances iris tone.
2. Great for all cataract cases.
3. Adequate for 90+ % IFIS cases.
4. Safe
IC xylo-phe
If you would like this
xylo-phe formulation
& use sheet, please
email me at:
ifix2is@Gmail.com
Steve A Arshinoff MD FRCSC OVD Stepladder Approach to IFIS AAO 2014
5
Successfully	
  Managing	
  IFIS	
  with	
  OVDs	
  
—  Step	
  1:	
   	
  Study	
  the	
  eye	
  &	
  warn	
  pa=ent.	
  	
  
	
   	
  Perform	
  preop	
  dila=on	
  test.	
  
	
  
—  Step	
  2: 	
  Prepare	
  the	
  AC.	
  
	
  
—  Step	
  3: 	
  Create	
  	
  IFIS	
  SoF	
  Shell	
  Bridge	
  	
  	
  (SSB)	
  
	
  	
  	
  	
  
—  Step	
  4: 	
  Perform	
  low	
  flow,	
  low	
  turbulence	
  surgery.	
  
	
  
—  Step	
  5: 	
  Malyugin	
  Ring	
  	
  	
  (or	
  iris	
  retractors)	
  rarely	
  needed	
  
Step 3: Create IFIS Soft Shell Bridge
1.  Tamponade	
  peripheral	
  Iris	
  with	
  Viscoat.	
  
2.  Blockade	
  &	
  Bridge	
  central	
  AC	
  with	
  Healon5.	
  
3.  LiF	
  H5	
  away	
  from	
  
ant.	
  capsule	
  with	
  BSS,	
  
or	
  xylo-­‐phe.	
  
4.  Keep	
  capsulorhexis	
  
smaller	
  than	
  pupil.	
  
Incision
1. Dispersive
filled space
(injected 1st)
2. Viscoadaptive
filled space
(injected 2nd)
3. BSS or xylo-phe
filled space
(injected 3rd)
I F I S S S B r i d g e
TSST & SSB
Tri-Soft Shell Technique Soft Shell Bridge
Arshinoff SA, Modabber M. Cataract Surgery in
Intraoperative Floppy Iris Syndrome (IFIS) Eyes. In
Chakrabarti A. Cataract Surgery in Diseased Eyes. Jaypee
Brothers Ltd., New Delhi. 2013.
Arshinoff Steve. Cataract Surgery in Compromised
Endothelium. In Chakrabarti A. Cataract Surgery in
Diseased Eyes. Jaypee Brothers Ltd., New Delhi. 2013.
è
Successfully	
  Managing	
  IFIS	
  with	
  OVDs	
  
—  Step	
  1:	
   	
  Study	
  the	
  eye	
  &	
  warn	
  pa=ent.	
  	
  
	
   	
  Perform	
  preop	
  dila=on	
  test.	
  
	
  
—  Step	
  2: 	
  Prepare	
  the	
  AC.	
  
	
  
—  Step	
  3: 	
  Create	
  	
  IFIS	
  SoF	
  Shell	
  Bridge	
  	
  	
  (SSB)	
  
	
  	
  	
  	
  
—  Step	
  4: 	
  Perform	
  low	
  flow,	
  low	
  turbulence	
  surgery.	
  
	
  
—  Step	
  5: 	
  Malyugin	
  Ring	
  	
  	
  (or	
  iris	
  retractors)	
  rarely	
  needed	
  
Steve A Arshinoff MD FRCSC OVD Stepladder Approach to IFIS AAO 2014
6
Step	
  4…	
  	
  Performing	
  Phaco	
  with	
  IFIS	
  SS	
  Bridge	
  
1.  Use	
  low	
  flow	
  →	
  low	
  turbulence	
  (Ozil).	
  
1.  Asp	
  flow	
  rate	
  ~	
  15-­‐25	
  cc/min.	
  
2.  Vacuum	
  <	
  250	
  mm	
  Hg.	
  
3.  BoZle	
  height	
  ~	
  75	
  cm	
  above	
  pt’s	
  head	
  
2.  Keep	
  phaco	
  and	
  I/A	
  =ps	
  deep	
  to	
  ‘rhexis.	
  
3.  Reinject	
  H5	
  (rarely	
  Viscoat)	
  as	
  needed:	
  (e.g.	
  aFer	
  hydrodissec=on)	
  
Incision
1. Dispersive
filled space
(injected 1 s t)
2. Viscoadaptive
filled space
(injected 2 nd ) 3. BSS or xylo-phe
filled space
(injected 3 rd )
Successfully	
  Managing	
  IFIS	
  with	
  OVDs	
  
—  Step	
  1:	
   	
  Study	
  the	
  eye	
  &	
  warn	
  pa=ent.	
  	
  
	
   	
  Perform	
  preop	
  dila=on	
  test.	
  
	
  
—  Step	
  2: 	
  Prepare	
  the	
  AC.	
  
	
  
—  Step	
  3: 	
  Create	
  	
  IFIS	
  SoF	
  Shell	
  Bridge	
  	
  	
  (SSB)	
  
	
  	
  	
  	
  
—  Step	
  4: 	
  Perform	
  low	
  flow,	
  low	
  turbulence	
  surgery.	
  
	
  
—  Step	
  5: 	
  Malyugin	
  Ring	
  	
  	
  (or	
  iris	
  retractors)	
  rarely	
  needed	
  
Summary: IFIS SS Bridge
1.  Considerable	
  varia=on	
  in	
  sensi=vity	
  to	
  Flomax.	
  
—  Preop	
  dila=on	
  test,	
  IC	
  phenylephrine	
  
2.  IFIS	
  SS	
  Bridge	
  enables	
  safe,	
  easy	
  
management	
  of	
  most	
  IFIS	
  cases.	
  
3.  Reestablish	
  the	
  IFIS	
  SSB	
  
structure	
  when	
  necessary	
  (H5).	
  
4.  Boris	
  Malyugin’s	
  ring	
  (MST)	
  
(Fyodorov	
  Ins=tute	
  Moscow).	
  
*Arshinoff Steve A. Modified SST-USST for tamsulosin-associated intraocular floppy-iris
syndrome. JCRS 2006; 32: 559-561. April.
Incision
1 Dispersive
filled space
(injected 1 st )
2. Viscoadaptive
filled space
(injected 2 nd )
3. BSS or xylo- phe
filled space
(injected 3 rd )
STEVE A. ARSHINOFF MD FRCSC
ifix2is@Gmail.com

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Floppy iris Syndrome

  • 1. Intraoperative Floppy Iris Syndrome: Pearls for Management and Prevention Senior Instructor: David F Chang MD Course: 214 Sunday, October 16, 2016 10:15 AM - 11:15 AM Room: E451A Published: 8-12-16 12:55 AM Join the conversation: #aao2016 © 2016 American Academy of Ophthalmology. All rights reserved.
  • 2. 1 Intraoperative Floppy Iris Syndrome David F. Chang, MD Intraoperative floppy iris syndrome (IFIS) in association with current or prior tamsulosin (Flomax) use was first described in 20051 . Besides a tendency for poor preoperative pupil dilation, severe IFIS exhibits a triad of intraoperative signs – iris billowing and floppiness, iris prolapse to the main and side port incisions, and progressive intraoperative miosis. Numerous studies have confirmed our initial suspicion that when such iris behavior is unexpected, the rate of cataract surgical complications is increased2-7 . Based upon parallel large retrospective and prospective clinical studies that John Campbell and the author had conducted, we identified a strong association of IFIS with either current or prior use of tamsulosin1 . This systemic alpha-1 antagonist is the most commonly prescribed medication for the symptomatic relief of benign prostatic hyperplasia (BPH). The association of IFIS with other systemic alpha-1 antagonists such as doxazosin, terazosin, and alfuzosin has since been documented as well4 . Clinical Features Although our original paper described a triad of signs with what we would now call severe IFIS, there is a wide range of clinical severity seen in clinical practice. In a prospective study of 167 eyes in patients taking tamsulosin, we classified IFIS as being mild (good dilation; some iris billowing without prolapse or constriction), moderate (iris billowing with some constriction of a moderately dilated pupil), or severe (classic triad and poor preoperative dilation)2 . Using this scale the distribution of IFIS severity was - 10% no IFIS, 17% mild IFIS, 30% moderate IFIS, and 43% severe IFIS. The tendency for iris prolapse often first appears during hydrodissection. Iris billowing may be seen when irrigation from the phaco tip is introduced, followed shortly thereafter by iris prolapse to both the incision and side port paracentesis. Progressive intraoperative pupil constriction may occur with our without accompanying iris prolapse. The combination of progressive miosis and iris floppiness increases the likelihood of aspirating the iris with the phaco tip. When surgeons have not recognized or anticipated IFIS, the rate of reported intraoperative complications has been increased. Multiple retrospective studies have published higher rates of capsular rupture and vitreous loss1, 4-7 . Complications of iris prolapse or aspiration include iridodialysis, iris sphincter damage, hyphema, and significant iris stromal or transillumination defects. Such iris trauma can cause permanent pupil deformity with glare or photophobia. In 2009, a retrospective Canadian study of nearly 100,000 male cataract surgeries documented a doubling of the rate of serious postoperative complications including retinal detachment, retained nuclear fragments, and severe inflammation in tamsulosin patients7 . One important caution with IFIS is that partial thickness sphincterotomies and manual pupil stretching are ineffective and can exacerbate iris billowing and prolapse1, 4 . A medical history of systemic alpha-1 antagonist use should alert the cataract surgeon to anticipate IFIS and to consider alternative small pupil management strategies. Our multicenter, prospective study of 169 consecutive cataract surgeries in tamsulosin patients attained excellent outcomes with low surgical complications by employing four specific operative techniques either alone or in combination2 . Using Healon 5 viscomydriasis, iris retractors, preoperative topical atropine administration, or pupil expansion rings, the incidence of posterior capsule rupture and vitreous loss was less than 1% in this clinical trial. However, because these
  • 3. 2 were highly experienced cataract surgeons, this study may not be representative of the general surgical experience with IFIS. In a 2008 ASCRS membership survey, 95% of the respondents reported that tamsulosin increased the difficulty of cataract surgery and 77% believed that it also increased the risk of complications3 . Specifically, during the prior two years, IFIS had increased the rate of posterior capsular rupture for 52% of respondents and the rate of significant iris trauma for 23% of the respondents. Pharmacology and Mechanism of IFIS Alpha-1 antagonists relax smooth muscle in the bladder neck and prostate. This facilitates more complete bladder emptying and thereby reduces the lower urinary tract symptoms of benign prostatic hyperplasia (BPH). There are at least three common human alpha-1 receptor subtypes - alpha-1A, alpha- 1B, and alpha-1D. Doxazosin (Cardura), terazosin (Hytrin), and alfuzosin (Uroxatral) are considered non-selective alpha-1 antagonists. Tamsulosin, however, is very selective for the alpha-1A receptor subtype, which predominates in the prostate as well as in the iris dilator smooth muscle. Because it theoretically should not block the vascular smooth muscle alpha-1D receptors, tamsulosin has a lower risk of causing postural hypotension. Although BPH is by far the most common indication, both men and women may take alpha-1 antagonists for other conditions. Tamsulosin is often briefly prescribed as an adjunctive medication to faciliate renal stone passage following shock wave lithotripsy. It may also be prescribed for urinary retention in women, and IFIS has been well documented in female patients taking tamsulosin. Finally, alpha-1 antagonists, such as doxazosin, terazosin, and prazosin, have long been prescribed for systemic hypertension. Ophthalmologists should also become familiar with two newer drugs prescribed for BPH symptoms. Silodosin (Rapaflo) is a systemic alpha blocker that was FDA approved for BPH in 2008. Like tamsulosin, it is also selective for the alpha-1A subtype, and is similar to tamsulosin in its strong propensity to cause IFIS. Jalyn is the brand name for the combination of dutasteride and tamsulosin, and was FDA approved in 2010. The combination of these two agents was shown in a large prospective clinical trial to be more effective at reducing the progression of BPH compared to either drug alone. All alpha-1 antagonists may inhibit pupil dilation and cause IFIS. A number of retrospective and prospective studies, however, have shown that the frequency and severity of IFIS is much higher with tamsulosin, as compared with non-selective alpha-1 antagonists3-10 . For example, the large retrospective Canadian study discussed earlier reported that tamsulosin significantly increased the rate of postoperative complications, but that non-selective alpha antagonists did not7 . A second Canadian retrospective study found that 86% of patients taking tamsulosin developed IFIS compared to only 15% of patients taking alfuzosin6 . A prospective masked trial from Italy comparing phaco in patients taking tamsulosin versus non-selective alpha blockers, and a large 2011 metanalysis of the literature reached this same conclusion that IFIS is more common and severe with tamsulosin9, 10 . Finally, a large prospective masked and controlled multicenter clinical study found that severe IFIS was more likely in patients taking tamsulosin, compared to those taking alfuzosin11 . These and other studies were further supported by the 2008 ASCRS survey finding that 90 percent of respondents with sufficient experience believed that IFIS was more common with tamsulosin than with nonselective alpha-1 antagonists3 . IFIS may also occur in patients without any history of alpha antagonist use. In addition to confirming that IFIS was strongly correlated with alpha-1 antagonists, one prospective study found that IFIS was also associated with systemic hypertension in the absence of alpha blockers
  • 4. 3 In our original publication, Campbell and I hypothesized that IFIS was a manifestation of decreased iris dilator muscle tone and loss of intraoperative structural rigidity1 . Two separate slit lamp OCT studies have reported significant thinning of the mid iris stromal thickness in tamsulosin patients when compared to control eyes. Another surprising but widespread finding is that IFIS can occur more than one year after tamsulosin has been discontinued1-4 . Ninety-five percent of ASCRS survey respondents have experienced IFIS in patients with only a prior history of alpha-1 antagonist use3 . Tamsulosin can even be recovered from aqueous samples taken 1-4 weeks after discontinuing the drug, suggesting that is has a very prolonged receptor binding time. One morphologic study of iridectomy samples from eyes demonstrating IFIS showed vacuolar degeneration of iris smooth muscle cells12 . A subsequent large histopathologic study of autopsy eyes from patients taking tamsulosin (26 eyes) also showed atrophy of the iris dilator muscle, which was consistent with a permanent drug effect on iris morphology13 . In 2012, Goseki and co-authors published their in vitro and histologic rabbit studies showing that in addition to smooth muscle alpha-1 receptors, tamsulosin also binds strongly to pigment granules in the iris. Pigment epithelial cells share nuclei with the adjacent smooth muscle cells, and this unique morphology may explain the histopathologic finding of dilator muscle atrophy in tamsulosin treated rabbits. Clearly, cataract surgical patients should be questioned about any prior alpha-1 antagonist use for this reason. In conclusion, the mechanism of IFIS is not fully understood. There are several anecdotal reports of IFIS occurring within days of initiating tamsulosin treatment, meaning that chronic drug use is not necessary to cause this syndrome. However, the stronger association with tamsulosin compared to non-selective alpha-1 antagonists and the occurrence of IFIS without any prior alpha blocker use suggests a more complex mechanism than that simply mediated by blockade of the alpha-1A receptor. IFIS appears to result from a combination of pharmacologic inhibition of iris smooth muscle contraction, and longer term smooth muscle degeneration relating to drug accumulation in adjacent iris pigment epithelial cells14 . These permanent structural changes would explain the occurrence of IFIS long after tamsulosin cessation. A stronger binding affinity to iris pigment granules and alpha-1A receptors might explain the greater propensity for tamsulosin to cause IFIS compared to non-selective alpha antagonists. Finally, the strong affinity for some systemic medications, such as psychotropic drugs, to bind to iris pigment granules might explain the occasional occurrence of IFIS in patients who have never taken alpha antagonists. Clinical and surgical management of IFIS Preoperative management The possibility of IFIS increases the importance of taking the patient’s medication history prior to cataract surgery. A history of systemic alpha antagonists may not be elicited without direct questioning about current or prior use of prostate medication3 . As discussed earlier, stopping tamsulosin preoperatively is of unpredictable and questionable value. With so many reported cases of IFIS occurring up to several years after the drug had been stopped, it is clear that ophthalmologists cannot rely solely upon drug cessation to prevent this condition. In the multicenter prospective trial mentioned earlier, tamsulosin was discontinued prior to surgery in 19% of patients, but did not result in any significant reduction in IFIS severity in this subgroup of eyes2 . In the 2008 ASCRS IFIS survey, 64% of respondents said that they never stop tamsulosin prior to surgery, compared to 11% who routinely do3 .
  • 5. 4 Preoperative atropine drops (e.g., 1% t.i.d. for 1-2 days preoperatively) can enhance cycloplegia as a means of preventing intraoperative miosis15 . However, the multicenter prospective tamsulosin study demonstrated that atropine, as a single strategy, is often ineffective for more severe cases of IFIS2 . In the ASCRS IFIS survey, 57% of respondents said that they never use topical atropine prior to surgery, compared to 19% who routinely do3 . Surgical management The inter-individual variability in the severity of IFIS makes it difficult to determine whether one surgical strategy is superior to another. The severity of IFIS is likely to be greater in patients taking tamsulosin. Poor preoperative pupil dilation and billowing of the iris immediately following instillation of intracameral lidocaine are also predictive of greater IFIS severity2, 4, 9 . In contrast, if the pupil dilates well preoperatively, mild to moderate IFIS is more likely but the surgeon should still be prepared for iris prolapse and miosis. Patients taking non-selective alpha-1 antagonists or who have already discontinued these medications for several months are most likely to display mild to moderate IFIS. Ideally, surgeons should be facile with several different approaches that may used alone or in combination to manage the iris in IFIS. In general, one should make a constructed shelved clear corneal incision, perform hydrodissection very gently, and consider reducing the irrigation and aspiration flow parameters if possible. Partial thickness sphincterotomies and mechanical pupil stretching, are ineffective for IFIS and may worsen the iris prolapse and miosis1, 4 . Intracameral alpha agonists Intracameral injection of alpha agonists such as phenylephrine or epinephrine, as first reported by Richard Packard and Joel Shugar respectively, is both a safe and inexpensive strategy for IFIS. By presumably saturating the alpha 1-A receptors, these agonists can further dilate the pupil. It may take a minute before the pupil slowly dilates further, but even if it does not, the alpha agonist will often increase iris dilator muscle tone, reducing billowing and the tendency for prolapse or sudden miosis. Because of the variable severity of IFIS intracameral alpha agonists work well in some eyes but may have no detectable effect in others16-19, 4 . In the United States, 1:1000 epinephrine has been commercially available from several manufacturers. The 30 ml bottle contains the preservative chlorobutanol and should not be used in the eye. Preservative- free 1:1000 epinephrine is packaged in single use 1 ml vials (1 mg/ml) and comes in two forms - with and without 0.1% bisulfite as a stabilizing agent. Bisulfite improves the stability of the solution by delaying oxidation of the active substance, but is toxic to the corneal endothelium due to its high buffer capacity. In addition, epinephrine taken directly from the vial has a low pH of approximately 3.0. Therefore, direct intracameral injection of undiluted 1:1000 epinephrine should be avoided. Instead, a 1:4000 epinephrine solution can be easily constituted by adding 0.2 mL of commercially available 1:1000 epinephrine to 0.6 mL of plain balanced salt solution (BSS) or BSS Plus in a 3-mL disposable syringe. This dilution raises the pH to a physiologic level and appears to sufficiently dilute the bisulfite stabilizing agent. Although bisulfite-free 1:1000 epinephrine (American Regent) is theoretically preferred for intracameral injection, there has been a nationwide shortage in the United States. The 1:4 dilution of bisulfite-
  • 6. 5 containing epinephrine has been safely used by the author, and was endorsed in a 2013 ASCRS clinical alert whenever bisulfite-free epinephrine is unavailable. Adding bisulfite-containing epinephrine to a 500 ml BSS irrigation bottle (off label) will not cause corneal endothelial toxicity because of the significant dilution. However, shortages of even bisulfite-containing 1:1000 epinephrine are now being reported in the United States. The author has noted an increased incidence of IFIS despite the absence of systemic alpha antagonists whenever epinephrine is omitted from the BSS irrigation bottle. Several publications report the safety and efficacy of unpreserved 1.5% intracameral phenylephrine for both IFIS prevention and routine surgical mydriasis 17-19 . One of these studies found no significant reduction in endothelial cell counts compared to non-treated eyes.19 Preservative-free phenylephrine 2.5% (Minims) is only commercially available outside the United States. Because these preparations still contain bisulfite, a 1:4 dilution with BSS, BSS Plus, or preservative-free lidocaine is also recommended. Lacking a commercial source in the United States, many surgeons (including the author) obtain bisulfite-free intracameral phenylephrine 1.5% prepared by compounding pharmacies. To avoid potential toxicity from preservative-containing phenylephrine, ophthalmologists should specify that only the unpreserved (raw) drug should be used as a compounding source. Prudent precautions for any drug compounded for intracameral injection include appropriate testing for pH, osmolality, and sterility. Ophthalmologists should check to see if the compounding pharmacy is accredited by the Pharmacy Compounding Accreditation Board (PCAB). When bisulfite-free epinephrine became unavailable, many surgeons questioned whether adding epinephrine to the BSS irrigating solution was actually necessary. A 2014 study subsequently reported that omitting epinephrine from the irrigating solution was associated with a 12-13% rate of moderate to severe IFIS in patients who had previously never taken any systemic alpha antagonists11 . Omidria (Omeros) received FDA approval in 2014. This commercial combination of phenylephrine and ketorolac is added to the irrigation solution. As first suggested by Bob Osher and Doug Koch, Healon 5 (Abbott Medical Optics) is a maximally cohesive ophthalmic visco-surgical device (OVD) that is particularly well suited for viscomydriasis and for blocking iris prolapse in IFIS. If mydriasis is still suboptimal after injecting epinephrine, Healon 5 can then be used to further mechanically expand the pupil. Viscomydriasis facilitates the capsulorhexis and combines with the epinephrine-induced iris rigidity to block iris prolapse. However, to avoid immediately aspirating Healon 5 one must employ low flow and vacuum parameters (e.g. < 175-200 mmHg; < 26 ml/min). This strategy is therefore less suitable if high vacuum settings are desired for denser nuclei. At higher aspiration flow rates, others have suggested that more dispersive OVDs, such as DisCoVisc (Alcon) or Viscoat (Alcon), may persist for longer periods within the eye. Finally, combining Healon 5 with Viscoat has been advocated as a combination strategy whereby the Viscoat will better resist aspiration and delay the evacuation of Healon 520 . Mechanical pupil expansion with iris retractors or devices such as the Malyugin ring assures a reliably wide pupil diameter that cannot abruptly constrict during surgery21 . Mechanical devices also permit surgeons to use their preferred OVD, phaco technique, and fluidic parameters. It is easier and safer to insert these devices prior to creation of the capsulorrhexis. If the pupil dilates poorly preoperatively (e.g. 3 – 5 mm diameter), or billows during injection of intracameral lidocaine, one should consider proceeding directly to mechanical devices because of the likelihood of severe IFIS. If the pupil dilates
  • 7. 6 well preoperatively, but begins to constrict or prolapse after hydrodissection or during phaco combining intracameral epinephrine and Healon 5 can be an excellent rescue technique that may avoid the need to insert mechanical devices. If iris retractors are used, one should retract the pupil margin with a second instrument to avoid hooking the capsulorrhexis margin with the retractors. Pupil Expansion Rings Pupil expansion rings are disposable devices that mechanically expand and maintain the intraoperative pupil diameter. Disposable PMMA rings, such as the Morcher 5S Pupil Ring and the Milvella Perfect Pupil, have grooved contours are threaded alongside the pupillary margin with dedicated metal injectors. Eagle Vision’s Graether disposable silicone pupil expansion ring is inserted with a single use plastic injector. All of these rings are relatively difficult to position if the pupil is less than 4 mm wide or if the anterior chamber is shallow. They will fail to engage the iris if the pupil diameter is larger than 7 mm. Most surgeons find the Malyugin ring (Microsurgical technologies, Redmond WA) to be the easiest and fastest pupil expansion device to insert and remove21 . This is a 5-0 polypropylene single use device that is introduced with a disposable injector. The way in which the iris drapes over the sides of the device creates a round 6 mm or 7 mm pupil diameter, depending on which of the two available sizes is used. The disposable injector tip fits through a 2.5 mm incision and is used to both place and extract the ring. Compared to bulkier and rigid plastic expansion rings, the thin profile of the Malyugin ring reduces the risk of accidental corneal or incisional trauma and does not impede instrument access to the cataract. The avoidance of multiple paracentesis sites, is advantageous in the presence of a bleb, a pterygium, and multiple RK scars, and avoids the problem of iris hooks being pushed against the lid speculum with a tight palpebral fissure. Finally, the smooth coils are very gentle on the pupil margin, and generally minimize iris sphincter damage. A similar iris expander device has been introduced by Oasis Medical. Iris Retractors The author prefers reusable 4–0 polypropylene retractors (available from Katena Products, Inc., Denville, NJ, and FCI Ophthalmics, Inc., Marshfield Hills, MA) to disposable 6–0 nylon retractors (available from Alcon Laboratories, Inc., Fort Worth, TX). Measuring 0.15mm in diameter, the 4–0 retractors are the same size and stiffness as the polypropylene haptic of an IOL. This greater rigidity, when compared to 6–0 nylon retractors, makes 4–0 retractors more durable and easier to manipulate. Furthermore, the 4-0 polypropylene hooks can be repeatedly autoclaved in the manufacturer supplied storage case, which makes them more cost effective than disposable hooks or pupil expansion rings. Before initiating the capsulorrhexis, 1-mm limbal paracenteses are created in each quadrant, including a separate stab incision just posterior to the temporal clear corneal incision. In this way, the phaco tip passes through a separate incision directly alongside and above the track for the subincisional retractor. As originally advocated by Oetting and Omphroy, placing the hooks in this diamond configuration has several advantages. The subincisional hook retracts the iris downward and out of the path of the phaco tip. This not only provides excellent access to subincisional cortex, but also avoids tenting the iris up in front of the phaco tip, such as occurs when the retractors are placed in a square configuration. This configuration also maximizes temporal exposure directly in front of the phaco tip as well as nasal exposure for placement of the chopper tip. Following IOL implantation, the iris retractors are removed,
  • 8. 7 rinsed in balanced salt solution, and gently dabbed with an instrument wipe to remove any viscoelastic residue. They are then stored in the autoclavable storage container. Iris retractors both enlarge and maintain an adequate pupillary size throughout the course of surgery. They provide sufficient tension to the iris stroma so that no prolapse can occur with IFIS. If the pupil is fibrotic, such as with chronic pilocarpine use or longstanding posterior synechiae, overstretching the iris can cause bleeding, tear the sphincter, and result in permanent mydriasis. It is therefore advisable to start with a smaller target diameter than needed with the expectation that the pupil opening will widen further during phaco. The likely reason for this is that the hydrostatic irrigation force propels the iris posteriorly against the four-point restraints of the anchored retractors. This effectively acts to mechanically stretch the pupil margin resulting in microscopic sphincter muscle tears. The exception is the IFIS pupil, which tends to be elastic and stretches maximally without tearing. Maximal widening with iris retractors can be employed with IFIS eyes. Eliciting a history of current or prior alpha-1 antagonist use should alert surgeons to anticipate IFIS and to employ these strategies either alone or in combination. Because of the variability in IFIS severity, many surgeons use a staged management approach4, 18 . Pharmacologic measures alone may be sufficient for mild to moderate IFIS cases. Even if they fail to enlarge the pupil, intracameral alpha agonists can reduce or prevent iris billowing and prolapse by increasing iris dilator muscle tone. If the pupil diameter is still inadequate, viscomydriasis with Healon 5 can further expand it for the capsulorrhexis step. Finally, mechanical expansion devices assure the best surgical exposure for severe IFIS, and should be considered when other risk factors, such as weak zonules or a brunescent nucleus are present. References: 1. Chang DF, Campbell JR. Intraoperative floppy iris syndrome associated with tamsulosin (Flomax). J Cataract Refract Surg 2005; 31: 664-673. 2. Chang DF, Osher RH, Wang L, Koch DD. Prospective multicenter evaluation of cataract surgery in patients taking tamsulosin (Flomax). Ophthalmology 2007;114:957-964. 3. Chang DF, Braga-Mele R, Mamalis N, et al., for the ASCRS Cataract Clinical Committee. Clinical experience with intraoperative floppy-iris syndrome. Results of the 2008 ASCRS member survey. J Cataract Refract Surg. 2008;34:1201- 1209. 4. Chang DF, Braga Mele R, Mamalis N, et al. for the ASCRS Cataract Clinical Committee. ASCRS White Paper: Intraoperative Floppy Iris Syndrome – A Clinical Review. J Cataract Refract Surg 2008;34:2153-2162. 5. Chadha V, Borooah S, Tey A, et al. Floppy iris behaviour during cataract surgery: associations and variations. Br J Ophthalmol. 2007; 91:40-42. 6. Blouin M, Blouin J, Perreault S, et al. Intraoperative floppy iris syndrome associated with Alpha-1 adrenoreceptors. Comparison of tamsulosin and alfuzosin. J Cataract Refract Surg 2007; 33:1227-1234. 7. Bell CM, Hatch WV, Fischer HD, Cernat G, Paterson JM, Gruneir A, Gill SS, Bronskill SE, Anderson GM, Rochon PA. Association between tamsulosin and serious ophthalmic adverse events in older men following cataract surgery. JAMA 2009; 301:1991-1996. 8. Palea S, Chang DF, Rekik M, et al. Comparative effect of alfuzosin and tamsulosin on the contractile response of isolated rabbit prostatic and iris dilator smooth muscles. Possible model for intraoperative floppy iris syndrome. J Cataract Refract Surg 2008; 34: 489-496. 9. Chatziralli IP, Sergentanis TN. Risk factors for intraoperative floppy iris syndrome: a meta-analysis. Ophthalmology 2011;118:730-735. 10. Casuccio A, Cillino G, Pavone C, et. al. Pharmacologic pupil dilation as a predictive test for the risk of intraoperative floppy-iris syndrome. J Cataract Refract Surg 2011;37: 1447-1454.
  • 9. 8 11. Chang DF, Campbell JR, Colin J, Schweitzer C. Prospective masked comparison of intraoperative floppy iris syndrome severity with tamsulosin versus alfuzosin. Ophthalmology 2014;121:829-834 12. Goseki T, Shimizu K, Ishikawa H, Nishimoto H, Uga S, Nemoto N, Patil PN. Possible mechanism of intraoperative floppy iris syndrome: a clinicopathological study. Br J Ophthalmol. 2008; 92: 1156-1158 13. Santaella RM, Destafeno JJ, Stinnett SS, et al. The effect of alpha1-adrenergic receptor antagonist tamsulosin (Flomax) on iris dilator smooth muscle anatomy. Ophthalmology. 2010;117:1743-1749. 14. Goseki T, Ishikawa H, Ogasawara S, et al. Effects of tamsulosin and silodisin on isolated albina and pigmented rabbit iris dilators – Possible mechanism of IFIS. J Cataract Refract Surg 2012;38: 1643-1649. 15. Masket S, Belani S. Combined preoperative topical atropine sulfate 1% and intracameral nonpreserved epinephrine hydrochloride 1:4000 [corrected] for management of intraoperative floppy-iris syndrome. J Cataract Refract Surg. 2007; 33:580-582. 16. Shugar, JK. Intracameral Epinephrine for Prophylaxis of IFIS [letter]. J Cataract Refract Surg 2006; 32: 1074- 1075. 17. Gurbaxani A, Packard R. Intracameral phenylephrine to prevent floppy iris syndrome during cataract surgery in patients on tamsulosin. Eye. 2007; 21:331-332. 18. Manvikar S, Allen D. Cataract surgery management in patients taking tamsulosin. J Cataract Refract Surg 2006; 32: 1611-1614 19. Lorente R, de Rojas V, Vázquez de Parga P, et al. Intracameral Phenylephrine 1.5% for Prophylaxis against Intraoperative Floppy Iris Syndrome: Prospective, Randomized Fellow Eye Study. Ophthalmology. 2012 Jun 16. [Epub ahead of print] 20. Arshinoff SA. Modified SST-USST for tamsulosin-associated intraocular floppy iris syndrome. J Cataract Refract Surg 2006; 32: 559-561. 21.Chang DF. Use of Malyugin pupil expansion device for intraoperative floppy iris syndrome: Results in 30 consecutive cases. J Cataract Refract Surg 2008;34:835-841.
  • 10. 9 Intraoperative Floppy Iris Syndrome Associated with Systemic Alpha-1 Antagonists 2014 ASCRS and AAO Educational Update Statement for Prescribing MDs In 2005 the U.S. Food and Drug Administration issued a new label warning about the association of α1- antagonists and intraoperative floppy iris syndrome (IFIS). Characterized by sudden intraoperative iris prolapse and pupil constriction, IFIS increases both the difficulty and the risk of cataract surgery1 . Some complications of IFIS have been sight threatening, including retinal detachment, lost lens fragments, endophthalmitis, and severe iris defects associated with permanent pupil deformity, glare, and photophobia1-3 . Tamsulosin is the most commonly prescribed α1-antagonist for benign prostate hyperplasia (BPH) in North America. Until the approval of silodosin, tamsulosin was the only systemic α1-antagonist that is selective for the α1-A receptor subtype that predominates in the prostate. Because vascular smooth muscle receptors are α1-B, the theoretical advantage of such receptor subtype selectivity is reduced risk of postural hypotension. Although initial blood pressure monitoring may be recommended when prescribing older non-selective α1-antagonists, such as terazosin and doxazosin, another non-selective α1-antagonist, alfuzosin, rarely causes postural hypotension and is associated with fewer cardiovascular adverse events 4-6 . It is well recognized that simply discontinuing oral α1-antagonists does not prevent IFIS1 . Studies of rabbit and human cadaver eyes have shown that tamsulosin is associated with atrophy of the iris dilator smooth muscle, and that this may be due to concentration of the drug in iris pigment granules7,8 . In 2008, the American Society of Cataract and Refractive Surgery (ASCRS) and the American Academy of Ophthalmology (AAO) jointly issued an educational update advisory on IFIS asking prescribing physicians to consider involving the cataract surgeon prior to initially prescribing non-emergent, chronic α1-antagonists in patients with known cataracts. Prescribing physicians were also asked to encourage patients to report any prior or current history of α1-antagonist use to their ophthalmic surgeon prior to undergoing any eye surgery. Since the 2008 advisory statement, additional evidence has emerged showing that severe IFIS is more likely to occur with tamsulosin compared to non-selective α1-antagonists. A 2011 meta-analysis of 17 published studies found that tamsulosin had a 40-fold higher pooled odds ratio for IFIS compared to alfuzosin and terazosin9 . A subsequent prospective, masked single surgeon study found severe IFIS more commonly with tamsulosin compared to non-selective α1-antagonists as a group10 . Finally, a newly published multicenter prospective study found that severe IFIS was statistically more likely with tamsulosin than alfuzosin11 . This was the first prospective, masked and controlled study to specifically compare two α1-antagonists with a low reported incidence of cardiovascular adverse events. In a 2008 survey, nearly two thirds of ophthalmologists said that if they themselves had a mildly symptomatic cataract they would either avoid tamsulosin or have their cataract removed first 12 . A newly published survey of primary care physicians from the University of California, San Francisco showed that only 35% were aware that α1-antagonists can cause cataract surgical complications; only half (17%) factored this into treatment considerations13 . Less than 10% inquire about a history of cataract prior to initiating α1-antagonist treatment and only 31% regularly advise patients to inform their ophthalmologist about taking these drugs. Most respondents (96%) desired more information on this topic.
  • 11. 10 We are issuing this updated educational statement for prescribing physicians based on these two newly published reports. Patients with symptomatic cataracts may wish to consider cataract surgery prior to initiating non-emergent α1-antagonist therapy. Because tamsulosin is associated with the highest risk of IFIS, patients with cataracts may wish to consider a non-selective α1-antagonist as initial treatment. References: 1. Chang DF, Braga-Mele R, Mamalis N, et al. ASCRS white paper: clinical review of intraoperative floppy-iris syndrome. J Cataract Refract Surg 2008;34:2153-2162. 2. Bell CM, Hatch WW, Fischer HD, et al. Association between tamsulosin and serious ophthalmic adverse events in older men following cataract surgery. JAMA 2009;301(19):1991-1996. 3. Chang DF. Floppy Iris Syndrome: Why BPH can complicate cataract surgery. Am Fam Physician 2009; 79: 1051, 1055-1056. 4. McVary KT, Roehrborn CG, Avins AL, et al. Update on AUA guideline on the management of benign prostatic hyperplasia. J Urol 2011; 185:1793-1803. 5. Buzelin JM, Delauche-Cavallier MD, Roth S, et al. Clinical uroselectivity: evidence from patients treated with slow-release alfuzosin for symptomatic benign prostatic obstruction. Br Journal Urol 1997;79:898-906. 6. Roehrborn CG. Alfuzosin: overview of pharmacokinetics, safety, and efficacy of a clinically uroselective alpha- blocker. Urology 2001;58:55-63. 7. Santaella RM, Destafeno JJ, Stinnett SS, et al. The effect of alpha1-adrenergic receptor antagonist tamsulosin (Flomax) on iris dilator smooth muscle anatomy. Ophthalmology 2010;117:1743-1749. 8. Goseki T, Ishikawa H, Ogasawara S, et al. Effects of tamsulosin and silodisin on isolated albina and pigmented rabbit iris dilators – Possible mechanism of IFIS. J Cataract Refract Surg 2012;38: 1643-1649. 9. Chatziralli IP, Sergentanis TN. Risk Factors for intraoperative floppy iris syndrome: A meta-analysis. Ophthalmology 2011; 118:730-735. 10. Casuccio A, Cillino G, Pavone C, et al. Pharmacologic pupil dilation as a predictive test for the risk of intraoperative floppy-iris syndrome. J Cataract Refract Surg 2011;37: 1447-1454. 11. Chang DF, Campbell JR, Colin J, Schweitzer C. Prospective masked comparison of intraoperative floppy iris syndrome severity with tamsulosin versus alfuzosin. Ophthalmology 2014;121:829-834 12. Chang DF, Braga-Mele R, Mamalis N, et al., for the ASCRS Cataract Clinical Committee. Clinical experience with intraoperative floppy-iris syndrome. Results of the 2008 ASCRS member survey. J Cataract Refract Surg. 2008;34:1201- 1209. 13. Doss EL, Potter MB, Chang DF. Primary Care Physicians Still Lack Awareness of IFIS. J Cataract Refract Surg 2014;40: 685-686
  • 12. 11 New studies on IFIS prompt ASCRS/AAO Educational Update for Prescribing Physicians (EyeWorld, April 2014) David F. Chang MD Two new studies on intraoperative floppy iris syndrome (IFIS) that I was involved with will be published this month, and they have prompted a renewed joint effort by ASCRS and AAO to educate prescribing physicians about the potential adverse effects of systemic α1-antagonists on cataract surgery. The first study (Chang DF, Campbell JR, Colin J, Schweitzer C. Prospective masked comparison of intraoperative floppy iris syndrome severity with tamsulosin versus alfuzosin. Ophthalmology 2014;121 (April):829-834) adds to the mounting evidence that tamsulosin creates a higher risk of severe IFIS, compared to non-selective α1-antagonists. Of the α1 receptor sub-types, the α1A receptor predominates in both the iris dilator and prostatic smooth muscle. Among α1-antagonists prescribed for benign prostatic hyperplasia (BPH), only tamsulosin and silodosin are sub-type selective and demonstrate the highest affinity for the α1A-receptor. Such receptor uroselectivity reduces the risk of postural hypotension due to blockade of the α1B receptors in vascular smooth muscle. All of the α1-antagonists can impair pupil dilation and cause IFIS. However, a number of prospective and retrospective studies have suggested that the frequency and severity of IFIS is greater in patients taking tamsulosin compared to the non-selective α1-antagonists, such as terazosin, doxazosin, and alfuzosin1, 2 . A 2011 meta-analysis of 17 published studies reported that tamsulosin had a 40-fold higher pooled odds ratio for IFIS compared to alfuzosin and terazosin2 . In vitro experiments demonstrated that tamsulosin is a much stronger antagonist of rabbit iris dilator muscle contraction than alfuzosin3 . Finally, a 2008 survey of ASCRS members indicated that 90% of respondents (with enough personal experience) felt that IFIS was more common with tamsulosin than with non-selective α1- antagonists4 . Because many of the prior studies were retrospective and were not masked, my co-investigators and I decided to conduct a multicenter prospective, masked, controlled comparison of tamsulosin and alfuzosin - the two α1-antagonists with the fewest reported cardiovascular adverse events. Undoubtedly one of the reasons that tamulosin became the most prescribed treatment for BPH was its theoretical uroselectivity and reduced incidence of postural hypotension. Although it is a non-selective α1- antagonist, alfuzosin is often referred to as “clinically uroselective”. The reduction in postural hypotension with alfuzosin is not due to receptor specificity, but rather to pill reformulation to slow release of the molecule in the GI tract. The study was conducted in France, where alfuzosin is more commonly prescribed than in most other countries. Sanofi Aventis, the manufacturer of alfuzosin (Uroxatral) is a French pharmaceutical company. Eight study surgeons from four sites enrolled 113 consecutive patients taking either tamsulosin or alfuzosin. Each time a study patient was enrolled, a control patient with no prior history of α1-antagonist use was enrolled by the same cataract surgeon on the same day. All 226 cases were videotaped and two masked ophthalmologists (John Campbell and myself) then graded every video for the presence and severity of IFIS. Severe IFIS—defined as iris billowing and prolapse with ≥ 2 mm of pupil constriction— was more common with either α1-antagonist compared to control eyes. However, severe IFIS was noted in 34.3 percent (24/70) of the tamsulosin eyes and 16.3 percent (7/43) of the alfuzosin eyes (P< 0.05). Therefore, if an α1-antagonist with a lower risk of cardiovascular side effects is indicated, patients with cataracts may want to try alfuzosin first.
  • 13. 12 Unfortunately for cataract surgeons, tamsulosin continues to be the most frequently prescribed medication for BPH, and its use will surely rise now that it is generic in the United States. As an alternative to α1-antagonists, 5-α reductase inhibitors (dutasteride and finasteride) are also effective and approved as medical monotherapy of BPH. However, a large multinational randomized trial demonstrated that the combination of dutasteride and tamsulosin was superior to either drug alone in the prevention of BPH progression. Ophthalmologists must therefore recognize that Jalyn is the brand name for this specific drug combination. Finally silodosin (Rapaflo) is the most recent α1-antagonist to be approved for BPH and most resembles tamsulosin in its α1A receptor sub-type specificity. The second study (Doss EL, Potter MB, Chang DF. Primary Care Physicians Still Lack Awareness of IFIS. J Cataract Refract Surg 2014;40 (April): 685-686) was a survey of primary care physicians from the University of California, San Francisco (UCSF) designed to assess their α1-antagonist prescribing patterns and their awareness of IFIS. A brief questionnaire was emailed to 350 health care providers in the UCSF Collaborative Research Network and 133 responded. Forty percent initiate BPH medical treatment at least twice a month. Overall, only 35% were aware that α1-antagonists can cause cataract surgical complications; only half (17%) factored this into treatment considerations. Less than 10% inquire about a history of cataract prior to initiating α1-antagonist treatment and only 31% regularly advise patients to inform their ophthalmologist about taking these drugs. Most respondents (96%) desired more information on this topic. Based on the new information from these two studies, the ASCRS Cataract Clinical Committee decided that a renewed effort to educate prescribing physicians treating BPH should be initiated. We have collaborated with the AAO in writing a joint educational document that was formally issued in early April. This new document updates the 2008 joint ASCRS/AAO IFIS educational statement which asked 1) prescribing physicians to consider involving the ophthalmologist prior to initiating α1-antagonists in patients with known cataracts and 2) reminding patients taking systemic α1-antagonists to report this medication history prior to having any eye surgery. The newly issued educational statement states, “Patients with symptomatic cataracts may wish to consider cataract surgery prior to initiating non- emergent α1-antagonist therapy. Because tamsulosin is associated with the highest risk of IFIS, patients with cataracts may wish to consider a non-selective α1-antagonist as initial treatment”. We have communicated with the American Academy of Family Physicians, the American College of Physicians, and the American Urological Association who will each help to disseminate this information to their respective memberships. In addition, this document is a concise, referenced summary that ophthalmologists can share with prescribing doctors in their communities on an individual basis. It can be downloaded from the ASCRS web site www.ascrs.org 1. Chang DF, Braga-Mele R, Mamalis N, et al. ASCRS white paper: clinical review of intraoperative floppy-iris syndrome. J Cataract Refract Surg 2008;34:2153-2162. 2. Chatziralli IP, Sergentanis TN. Risk Factors for intraoperative floppy iris syndrome: A meta-analysis. Ophthalmology 2011; 118:730-735. 3. Palea S, Chang DF, Rekik M, et al. Comparative effect of alfuzosin and tamsulosin on the contractile response of isolated rabbit prostatic and iris dilator smooth muscles. Possible model for intraoperative floppy iris syndrome. J Cataract Refract Surg 2008; 34: 489-496. 4. Chang DF, Braga-mele R, Mamalis N, et al. Clinical experience with intraoperative floppy-iris syndrome. Results of the 2008 ASCRS member survey. J Cataract Refract Surg 2008; 34:1201-1209.
  • 14. Steve A Arshinoff MD FRCSC OVD Stepladder Approach to IFIS AAO 2014 1 Managing Flomax IFIS (with OVDs*) A Step Ladder Approach *Arshinoff Steve A. Modified SST-USST for tamsulosin-associated intraocular floppy-iris syndrome. JCRS 2006; 32: 559-561. April. Course 418 Oct. 20, 2014 Incision 1. Viscoat filled space (injected 1st) 2. Viscoadaptive filled space (injected 2nd) 3. BSS filled space (injected 3rd) I F I S S S B r i d g e Steve A. Arshinoff MD FRCSC Eye Associates, Humber River Hospital University of Toronto, Toronto, ON, Canada McMaster University, Hamilton, ON, Canada Financial Disclosures: Alcon Laboratories Inc. - C Abbott Medical Optics - C Bausch & Lomb – C Anteis – C iMed Pharma - C Arctic Dx. - C Two physical components of Phaco: Phaco power modulations Rheology = Control of flow in, & maintenance of, the AC. OVDs are pseudoplastic fluids used to create an AC surgical environment optimized for surgery. Creative use of OVDs reduces complication rates. “Phaco is Rheology” TSST Arshinoff SA, Norman R. JCRS 2013; 39: 1196-1203. Tri-Soft Shell Technique (TSST) logical system of unification of soft shell techniques to make them easier to understand & perform. Successfully  Managing  IFIS  with  OVDs   —  Step  1:    Study  the  eye  &  warn  pa=ent.        Perform  preop  dila=on  test.     —  Step  2:  Prepare  the  AC.     —  Step  3:  Create    IFIS  SoF  Shell  Bridge      (SSB)           —  Step  4:  Perform  low  flow,  low  turbulence  surgery.     —  Step  5:  Malyugin  Ring      (or  iris  retractors)  rarely  needed  
  • 15. Steve A Arshinoff MD FRCSC OVD Stepladder Approach to IFIS AAO 2014 2 Successfully  Managing  IFIS  with  OVDs   —  Step  1:    Study  the  eye  &  warn  pa=ent.        Perform  preop  dila=on  test.     —  Step  2:  Prepare  the  AC.     —  Step  3:  Create    IFIS  SoF  Shell  Bridge      (SSB)           —  Step  4:  Perform  low  flow,  low  turbulence  surgery.     —  Step  5:  Malyugin  Ring      (or  iris  retractors)  rarely  needed   Warn    Flomax    pts:     Flomax  pa=ents  are  asked  to   have  their  doctor  change  them   to  a  different  BPH  α  blocker     before  surgery.     (  This  may  not  make  much  difference.  )   Step  1:    Carefully  examine  iris  &  pupil   —  See  all  small  pupil  cases  ≤  2  weeks  preop!     -­‐  Is  it  IFIS  or  “pseudo  IFIS”?          Iris  atrophic?    post  synechiae?      Fibro=c  pupillary  ring?     —  Preop  pupil  dila=on  test:   1.  tropicamide  1%  gDs  x  2,   phenylephrine    2.5%  x  1   2.  wait  20  min:    observe  …   Flomax  effect  is  variable!!     Blue  eyes  much  worse  than  brown.   > 6.5 mm = no problem - 2x adrenaline in bottle - intracam. Xylo-phe. ~ 6.0 mm = minor problems - tight incisions !! - IFIS Soft Shell Bridge < 5.5 mm = serious IFIS - expect trouble. - ? + Malyugin Ring no dilation = not likely Flomax – stretch pupils Successfully  Managing  IFIS  with  OVDs   —  Step  1:    Study  the  eye  &  warn  pa=ent.        Perform  preop  dila=on  test.     —  Step  2:  Prepare  the  AC.     —  Step  3:  Create    IFIS  SoF  Shell  Bridge      (SSB)           —  Step  4:  Perform  low  flow,  low  turbulence  surgery.     —  Step  5:  Malyugin  Ring      (or  iris  retractors)  rarely  needed  
  • 16. Steve A Arshinoff MD FRCSC OVD Stepladder Approach to IFIS AAO 2014 3 Step  2:    Preparing  the  AC  for  IFIS   1.  Use  IC  xylo-­‐phe  &  2  x  adrenaline  in  the  boZle.   -­‐  1cc.  intracardiac  1:1,000  adrenaline  /  500  cc  BSS       2.  Long,  =ght  incisions    -­‐  prevent  iris  prolapse.   *Arshinoff Steve. Cataract Surgery in Compromised Endothelium. In Chakrabarti A. Cataract Surgery in Diseased Eyes. Jaypee Brothers Ltd., New Delhi. 2013. * Intracameral    Sympathomime=c    Agents                                      Agent:        Source    “stabilizer”   1.  Irrigant  boZle  Epinephrine  1mg/ml        Hospira                        metabisulfite  -­‐  1:500  dilu=on  in  irrigant  BSS   2.  *Non-­‐preserved  Epi  injec=on,  USP  1:1,000  American  Regent              none   1  ml  ampules:  **dilute  1:3  with  BSS  –  J  Shugar   3.    +Phenylephrine  10%  minims  diluted  in  5  cc  BSS                    Chauvin  (B&L)  metabisulfite      -­‐  1st  proposed  by  David  Allen,  Richard  Packard        Na2EDTA       * Slack JW, Edelhauser HF, Helenek MJ. A bisulfite-free intraocular epinephrine solution ** Shugar J. Epinephrine for IFIS prophylaxis. JCRS 2006: 32; 1074-1075 + Manvikar S, Allen D. cat surg in pts taking tamsulosin. JCRS 2006. 32: 1611-14. Packard R. CRST 2007. May. Xylocaine –Phenylephrine to facilitate cataract surgeryINTRACAMERAL MYDRIATICS IN PHACOEMULSIFICATION The mean corneal endothelial cell loss at 1 month was 2.3% Ϯ 6.1% in the intracameral group and 4.1% Ϯ 6.0% in the topical group (P ϭ .25) (Table 1). The postoperative cell counts were not significantly different from the preoperative values (P ϭ .19 and P ϭ .17, respectively). In contrast, cells were more irregular and elongated postoperatively in both the in- tracameral group and the topical group as assessed by HSF (P ϭ .0092 and P ϭ .0010, respectively) and by DE (P ϭ .0037 and PϽ.001, respectively); there were no significant differences between the groups (Table 1). A significant decrease in pulse rate occurred in the topical group (P ϭ .0055) but not in the intracameral group (P ϭ .15). The difference in pulse decelerationFigure 1. (Lundberg) Pupil size (mean Ϯ SD) after injection of intra- cameral mydriatics (s ϭ seconds). was significant between the groups (Table 1). The slightly increased postoperative MAP did not differ sig- nificantly from the preoperative values in either the sure ϫ 1/3 ϩ diastolic blood pressure ϫ 2/3. Finally, all intracameral group or the topical group (P ϭ .072 and patients graded their subjective sensation of pain and glare P ϭ .10, respectively). during the procedure using a visual analog scale from 0 to 10. Complications in the intracameral group were 1A binary logistic regression model was used to evaluate case of slight damage to the capsulorhexis and in thewhether preoperative differences existed between the groups in BCVA, IOP, pseudoexfoliation, iris color, cataract classifi- topical group, 1 case each of iris prolapse and posterior cation, corneal endothelial cell count, pupil size, corneal capsule rupture without vitreous loss. Mechanical pupil thickness, pulse, MAP, age, or sex. There were no significant dilation was performed in 3 eyes in the intracameral differences in the preoperative parameters between the 2 groups group and 1 eye in the topical group.(P ϭ .72). The Mann-Whitney U test was used to evaluate pain, glare, and cell and flare data, and the Student 2-tailed t test was used for all other statistical comparisons. A DiscussionP value less than 0.05 was considered statistically significant. Mean values are given with their standard deviations. This study shows that mydriatics can be safely in- jected into the anterior chamber before phacoemulsifi- cation cataract surgery in sufficient doses to allow theResults Xylo + 0.1% Phe 1st proposed: Lundberg B, Behndig A. Intracameral mydriatics in phacoemulsification cataract surgery. JCRS 2003; 29: 2366-71. used 0.1%phenylephrine Intracameral Phenylephrine —  Dose response: Behndig A, Lundberg B. Mydriatic response to different concentrations of intracameral phenylephrine in humans. JCRS 2010; 36:1682-86. ≥ 1.5% phenylephrine yields superior dilation. —  IFIS: Gurbaxani A, Packard R. Intracameral phenylephrine to prevent floppy iris syndrome during cataract surgery in patients on tamsulosin. Eye 2007; 21: 331-2 Diluted phenylephrine B&L minims 2.5%: Add 0.25 ml + 1 ml BSS è 0.5% —  Bill Myers (Chicago) – IC phenylephrine obtained from Leiter’s in US. —  Ramon Lorente (Spain) – 1.5% phenylephrine IC for IFIS. Ophthalmology 2012; 119: 2053-8. Figure 1. Mean pupil sizes over time after intracameral injection of 0.15 mL phenylephrine at different concentrations ≥ 1.5% < 1.5% Phe
  • 17. Steve A Arshinoff MD FRCSC OVD Stepladder Approach to IFIS AAO 2014 4 IC xylo-phe 1.  Add minim (0.3 cc) 10% phenylephrine to 5 cc BSS in 6 cc syringe (è 0.57%, diluted 17.7x). 2.  Add 3-4 drops of above phenylephrine solution to xylocaine (Astra 1% non-preserved insotonic xylo polyamp) on scrub tray (è0.05%, diluted ≥200x). 3.  Inject 0.1 cc IC xylo-phe thru side port. (1.) — Almost all pupils dilate to 8-9 mm in 10 seconds. 4.  Inject 0.1 cc IC xylo-phe under OVD. (2.) — 1 more mm of pupil dilation. IC xylo-phe: Why it works so well. —  Xylocaine: Completely paralyzes sphincter. —  Phenylephrine: Aggressively stimulates dilator. * Benefits: 1. Maximally enhances iris tone. 2. Great for all cataract cases. 3. Adequate for 90+ % IFIS cases. 4. Safe IC xylo-phe If you would like this xylo-phe formulation & use sheet, please email me at: ifix2is@Gmail.com
  • 18. Steve A Arshinoff MD FRCSC OVD Stepladder Approach to IFIS AAO 2014 5 Successfully  Managing  IFIS  with  OVDs   —  Step  1:    Study  the  eye  &  warn  pa=ent.        Perform  preop  dila=on  test.     —  Step  2:  Prepare  the  AC.     —  Step  3:  Create    IFIS  SoF  Shell  Bridge      (SSB)           —  Step  4:  Perform  low  flow,  low  turbulence  surgery.     —  Step  5:  Malyugin  Ring      (or  iris  retractors)  rarely  needed   Step 3: Create IFIS Soft Shell Bridge 1.  Tamponade  peripheral  Iris  with  Viscoat.   2.  Blockade  &  Bridge  central  AC  with  Healon5.   3.  LiF  H5  away  from   ant.  capsule  with  BSS,   or  xylo-­‐phe.   4.  Keep  capsulorhexis   smaller  than  pupil.   Incision 1. Dispersive filled space (injected 1st) 2. Viscoadaptive filled space (injected 2nd) 3. BSS or xylo-phe filled space (injected 3rd) I F I S S S B r i d g e TSST & SSB Tri-Soft Shell Technique Soft Shell Bridge Arshinoff SA, Modabber M. Cataract Surgery in Intraoperative Floppy Iris Syndrome (IFIS) Eyes. In Chakrabarti A. Cataract Surgery in Diseased Eyes. Jaypee Brothers Ltd., New Delhi. 2013. Arshinoff Steve. Cataract Surgery in Compromised Endothelium. In Chakrabarti A. Cataract Surgery in Diseased Eyes. Jaypee Brothers Ltd., New Delhi. 2013. è Successfully  Managing  IFIS  with  OVDs   —  Step  1:    Study  the  eye  &  warn  pa=ent.        Perform  preop  dila=on  test.     —  Step  2:  Prepare  the  AC.     —  Step  3:  Create    IFIS  SoF  Shell  Bridge      (SSB)           —  Step  4:  Perform  low  flow,  low  turbulence  surgery.     —  Step  5:  Malyugin  Ring      (or  iris  retractors)  rarely  needed  
  • 19. Steve A Arshinoff MD FRCSC OVD Stepladder Approach to IFIS AAO 2014 6 Step  4…    Performing  Phaco  with  IFIS  SS  Bridge   1.  Use  low  flow  →  low  turbulence  (Ozil).   1.  Asp  flow  rate  ~  15-­‐25  cc/min.   2.  Vacuum  <  250  mm  Hg.   3.  BoZle  height  ~  75  cm  above  pt’s  head   2.  Keep  phaco  and  I/A  =ps  deep  to  ‘rhexis.   3.  Reinject  H5  (rarely  Viscoat)  as  needed:  (e.g.  aFer  hydrodissec=on)   Incision 1. Dispersive filled space (injected 1 s t) 2. Viscoadaptive filled space (injected 2 nd ) 3. BSS or xylo-phe filled space (injected 3 rd ) Successfully  Managing  IFIS  with  OVDs   —  Step  1:    Study  the  eye  &  warn  pa=ent.        Perform  preop  dila=on  test.     —  Step  2:  Prepare  the  AC.     —  Step  3:  Create    IFIS  SoF  Shell  Bridge      (SSB)           —  Step  4:  Perform  low  flow,  low  turbulence  surgery.     —  Step  5:  Malyugin  Ring      (or  iris  retractors)  rarely  needed   Summary: IFIS SS Bridge 1.  Considerable  varia=on  in  sensi=vity  to  Flomax.   —  Preop  dila=on  test,  IC  phenylephrine   2.  IFIS  SS  Bridge  enables  safe,  easy   management  of  most  IFIS  cases.   3.  Reestablish  the  IFIS  SSB   structure  when  necessary  (H5).   4.  Boris  Malyugin’s  ring  (MST)   (Fyodorov  Ins=tute  Moscow).   *Arshinoff Steve A. Modified SST-USST for tamsulosin-associated intraocular floppy-iris syndrome. JCRS 2006; 32: 559-561. April. Incision 1 Dispersive filled space (injected 1 st ) 2. Viscoadaptive filled space (injected 2 nd ) 3. BSS or xylo- phe filled space (injected 3 rd ) STEVE A. ARSHINOFF MD FRCSC ifix2is@Gmail.com