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   Using multiple trabecular micro-bypass stents
  in cataract patients to treat open-angle glaucoma
                             Graham W. Belovay, MD, Abdulla Naqi, MD, Brian J. Chan, MD,
                                    Mahmoud Rateb, MD, Iqbal Ike K. Ahmed, MD



                   PURPOSE: To evaluate the efficacy of multiple trabecular micro-bypass stents combined with
                   cataract surgery in patients with open-angle glaucoma (OAG) and cataract.
                   SETTING: Private practice, Mississauga, Ontario, Canada.
                   DESIGN: Comparative case series.
                   METHODS: Eyes with OAG had implantation of 2 or 3 micro-bypass stents with concurrent cataract
                   surgery and follow-up through 1 year. Efficacy measures were intraocular pressure (IOP) and
                   topical ocular hypotensive medication use. Safety assessment included complications and
                   corrected distance visual acuity (CDVA).
                   RESULTS: The study comprised 53 eyes (47 patients); 28 had implantation of 2 stents and 25 had
                   implantation of 3 stents. The overall mean 1-year postoperative IOP was 14.3 mm Hg, which was
                   significantly lower than preoperative IOP overall and in each group (P<.001). The target IOP was
                   achieved in a significantly higher proportion of eyes at 1 year versus preoperatively (77% versus
                   43%; P<.001). Overall, 83% of eyes had a decrease in topical ocular hypotensive medication at
                   1 year from preoperatively, with a 74% decrease in the mean number of medications (from
                   2.7 to 0.7) at 1 year (P<.001). The 3-stent group was on significantly fewer medications than the
                   2-stent group at 1 year (0.4 versus 1.0; PZ.04).
                   CONCLUSIONS: Using multiple micro-bypass stents with concurrent cataract surgery led to a mean
                   postoperative IOP of less than 15 mm Hg and allowed patients to achieve target pressure control
                   with significantly fewer medications through 1 year.
                   Financial Disclosure: Dr. Ahmed is a consultant to Glaukos Corp. No other author has a financial or
                   proprietary interest in any material or method mentioned.
                   J Cataract Refract Surg 2012; 38:1911–1917 Q 2012 ASCRS and ESCRS



Open-angle glaucoma (OAG) can be managed in sev-                       complications, including infection, corneal decompen-
eral ways depending on the target intraocular pressure                 sation, choroidal hemorrhage, hypotony, diplopia, and
(IOP), medication use, severity of glaucoma, quality of                vision loss.1–7 Thus, despite their effective control of
life, surgeon experience, and the surgical techniques                  IOP, they should not be considered benign operations.
available. In general, newly diagnosed glaucoma is                        In the case of mild to moderate glaucoma and
managed with medical therapy, possibly in combina-                     clinically significant cataract, less invasive surgical
tion with laser trabeculoplasty. It is typically not until             alternatives, such as microinvasive surgeries, can be
the later stages of the disease when the patient is on                 performed in conjunction with cataract surgery. The
maximum medical therapy that ab externo filtering                      use of less invasive treatments to reduce IOP and
procedures are considered.                                             glaucoma medications is a desirable approach to
   In the case of glaucoma and visually clinically signif-             treating glaucoma, especially if this approach does
icant cataract, combined cataract and glaucoma proce-                  not limit other options in the future.
dures have been shown to not only lower IOP but to                        The iStent implant (Glaukos Corp.) is a trabecular
also reduce the number of glaucoma medications.1–3                     bypass device. It is the first of a class of new ab interno
Unfortunately, traditional ab externo glaucoma                         devices that enables minimally invasive glaucoma
surgical procedures (eg, trabeculectomy, tubes, deep                   surgery. Several studies have shown the effectiveness
sclerectomy) are associated with significant risks and                 and safety of implanting this stent in eyes with mild to

Q 2012 ASCRS and ESCRS                                                                                    0886-3350/$ - see front matter     1911
Published by Elsevier Inc.                                                                    http://dx.doi.org/10.1016/j.jcrs.2012.07.017
1912                                         MULTIPLE TRABECULAR MICRO-BYPASS STENTS




moderate glaucoma to achieve this goal. Fea8 and                           Preoperatively, demographic information (age, sex, and
Samuelson et al.9 compared phacoemulsification                          race), ocular history (including type of glaucoma), glaucoma
                                                                        medications, and results from a recent visual field were
with and without stent implantation and found that
                                                                        recorded. The preoperative ocular examination included
the combined surgery was more effective at control-                     Snellen corrected distance visual acuity (CDVA), IOP
ling IOP than cataract surgery alone; the safety profiles               (Goldmann applanation tonometry [GAT]), cup-to-disc ratio,
of both groups were similar. Spiegel et al.10,11,A stud-                anterior chamber angle (Shaeffer grade), and lens opacity grade
ied stent implantation with concurrent cataract                         (Lens Opacity Classification III15). Target IOP and the stage of
                                                                        glaucoma were determined using the Canadian Ophthalmo-
surgery in glaucoma patients and found effective
                                                                        logical Society evidence-based clinical practice guidelines for
IOP control through 24 months (16.9 mm Hg versus                        the management of glaucoma in the adult eye.16 Patients
21.9 mm Hg preoperatively). Also, medication use                        with a remote history of angle-closure glaucoma requiring laser
was reduced (0.4 versus 1.4 preoperatively). None of                    peripheral iridotomy and open angles at the time of surgery
these studies reports major surgical complications.                     were classified as mixed mechanism. Ocular hypotensive
                                                                        medications were not discontinued before surgery.
   Earlier work12 suggests that more advanced OAG
                                                                           Using the technique described by Spiegel et al.,10 the same
patients may require postoperative target pressures                     surgeon (I.I.K.A.) implanted 2 or 3 iStents in the eye after
of 15 mm Hg or less to prevent further glaucomatous                     phacoemulsification. The stents were inserted in the nasal re-
progression. Studies of the trabecular bypass stent by                  gion of the trabecular meshwork separated by 1 to 2 clock
Zhou and Smedley13 and Bahler14 addressed this                          hours. Eyes requiring greater IOP control (ie, to achieve the
                                                                        target IOP) as determined by the operating surgeon received
lower threshold. They established a theoretical in vitro
                                                                        3 stents instead of 2 stents. Intraoperatively, the type of intra-
perfusion model that predicted that multiple                            ocular lens, the number of stents implanted, and the compli-
trabecular stents may increase facility of outflow and                  cations were recorded.
reduce IOP versus a single implant. Bahler et al.14                        Postoperatively, patients were seen at 1 day, 1 week, and
found that subsequent placement of a second stent                       1, 3, 6, and 12 months. Snellen visual acuity, IOP (with GAT),
                                                                        glaucoma medications, stent placement using gonioscopy,
reduced the mean IOP by an additional 3.6 mm Hg
                                                                        and complications were assessed at these visits by the exam-
in 7 of 9 enucleated cadaver eyes.                                      ining physician. The examiners were not masked to the num-
   The current study evaluated the effects of multiple                  ber of stents. The number of ocular hypotensive medications
trabecular micro-bypass stents in combination with                      was reduced gradually based on the postoperative IOP tar-
cataract surgery on IOP and glaucoma medication                         get in each case.
                                                                           Statistical analyses were performed using SPSS software
use in patients with OAG and concurrent cataract.
                                                                        (version 15, International Business Machines Corp.) in an
                                                                        intent-to-treat analysis. A paired t test was used to determine
                                                                        the significance of the change in IOP and glaucoma medica-
PATIENTS AND METHODS                                                    tions from baseline to 12 months. A 2-sample t test was used
                                                                        to compare the IOP and glaucoma medications between each
This was an open-label nonrandomized prospective single-                time point and each stent group. A Mann-Whitney test was
center series of eyes with OAG that had implantation of                 performed to compare outcomes between the 2-stent group
2 or 3 trabecular micro-bypass stents with concurrent cata-             and the 3-stent group. Demographic data were compared be-
ract surgery. Key inclusion criteria were visually significant          tween groups using a 2-sample t test or Fisher exact test. Sig-
cataract, IOP that was not well controlled on medication or             nificance was set at 5%.
was well controlled but with a substantial (R3) medication
burden, and follow-up through 12 months postoperatively.
Ethics approval was obtained from IRB Services, Ltd., Au-
rora, Ontario, Canada, and all patients provided informed               RESULTS
consent.                                                                The study enrolled 53 eyes of 47 patients. Table 1A
                                                                        shows the patients’ demographics and Table 1B, the
Submitted: November 29, 2011.                                           preoperative characteristics. All eyes had cataract
Final revision submitted: July 3, 2012.                                 requiring surgery. Glaucoma diagnoses at time of sur-
Accepted: July 6, 2012.                                                 gery included primary OAG, pseudoexfoliative, and
                                                                        mixed mechanism. Previous glaucoma surgeries
From the University of Toronto (Belovay, Naqi, Rateb, Ahmed),
                                                                        included laser peripheral iridotomy, argon laser trabe-
Toronto, Ontario and McMaster University (Chan), Hamilton, Ontario,
Canada; University of Utah (Ahmed), Salt Lake City, Utah, USA.
                                                                        culoplasty (ALT), and selective laser trabeculoplasty
                                                                        (SLT). Eight eyes had 2 procedures (laser peripheral
Presented in part at the American Glaucoma Society Meeting, San         iridotomy and ALT, n Z 1; laser peripheral iridotomy
Diego, California, USA, March 2010, and at the ASCRS Symposium          and SLT, n Z 4; ALT and SLT, n Z 3). Those with laser
on Cataract, IOL and Refractive Surgery, Boston, Massachusetts,         peripheral iridotomies, with the exception of the mixed-
USA April 2010.                                                         mechanism patients, had the procedures performed by
Corresponding author: Iqbal Ike K. Ahmed, MD, Credit Valley             their referring physicians for reasons unknown. No eye
EyeCare, 3200 Erin Mills Parkway, Unit 1, Mississauga, Ontario,         had a history of trabeculectomy or shunt implantation.
L5L 1W8, Canada. E-mail: ike.ahmed@utoronto.ca.                         Approximately half the eyes had a preoperative CDVA

                                              J CATARACT REFRACT SURG - VOL 38, NOVEMBER 2012
MULTIPLE TRABECULAR MICRO-BYPASS STENTS                                               1913




 Table 1A. Demographics.

 Parameter                           Overall (N Z 47)*                    2-Stent Group (n Z 26)        3-Stent Group (n Z 23)       P Value

 Mean age (y) G SD                       77.2 G 7.4                             78.8 G 7.0                    75.0 G 7.3               .07†
 Sex, n (%)                                                                                                                            .54z
   Male                                    14 (30)                                7 (27)                        9 (39)
   Female                                  33 (70)                               19 (73)                       14 (61)
 Race, n (%)                                                                                                                           .43x
   White                                   29 (62)                               18 (69)                       11 (48)
   Black                                    7 (15)                                4 (15)                        4 (17)
   South Asian                              7 (15)                                2 (8)                         5 (22)
   Far East Asian                           4 (8)                                 2 (8)                         3 (13)

 *Two patients received 2 stents in 1 eye and 3 stents in the other eye
 †
   Two-sample t test
 z
   Fisher exact test
 x
   Fisher exact test with Monte Carlo simulation



of 20/50 to 20/100, with the remainder having a CDVA                                 Intraocular Pressure and Medications by Stent Group
of 20/40 or better or 20/200 or worse. Eight eyes had                                   The 1-year IOP was significantly lower than the
mild glaucoma, 23 had moderate glaucoma, and 22                                      preoperative IOP in the 2-stent group (mean
had advanced glaucoma.                                                               13.8 mm Hg postoperatively) and the 3-stent group
   Of the 53 eyes, 28 had implantation of 2 stents and                               (mean 14.8 mm Hg postoperatively) (both P!.001)
25 had implantation of 3 stents. Forty-one patients                                  (Figure 2). There was no significant difference in IOP
(87%) had 2 or 3 stents implanted in 1 eye only. Two                                 reduction between the 2 groups (PZ.78). Twenty-
patients received 3 stents bilaterally, 2 received 2 stents                          one eyes (75%) in the 2-stent group achieved a 1-year
bilaterally, and 2 received 2 stents in 1 eye and 3 stents                           postoperative IOP of 15 mm Hg or less. The IOP reduc-
in the other eye.                                                                    tion was greater in the 3-stent group, with a mean
   The mean preoperative medicated IOP was similar                                   reduction of 3.9 mm Hg versus 3.5 mm Hg in the
between the 2-stent group and the 3-stent group. Over-                               2-stent group (PZ.76). Target IOP was achieved by
all preoperatively, fewer than half the eyes were at the                             20 eyes (71%) in the 2-stent group and 21 eyes (84%)
target IOP levels.                                                                   in the 3-stent group. The mean number of topical ocu-
   The mean number of preoperative medications was                                   lar hypotensive medications significantly decreased to
similar between the 2-stent group and the 3-stent                                    1.0 medication and 0.4 medication, respectively, at
group. More eyes in the 3-stent group than in the                                    1 year (P!.001) (Figure 3), representing a 64% reduc-
2-stent group were taking 4 or more medications.                                     tion in medications in the 2-stent group and 85%
                                                                                     reduction in the 3-stent group. The 3-stent group was
Overall Intraocular Pressure and Medications                                         on significantly fewer medications at 1 year than the
   Overall, the decrease in the mean IOP from preop-                                 2-stent group (PZ.04). At 1 year, medication use had
eratively (18.0 G 4.0 mm Hg) to 1 year postopera-                                    been stopped in 13 eyes (46%) in the 2-stent group
tively (14.3 G 2.9 mm Hg) was statistically                                          and 18 eyes (72%) in the 3-stent group.
significant (P!.001) (Figure 1). Thirty-seven eyes
(70%) achieved an IOP of 15 mm Hg or less at 1                                       Complications
year, and 41 eyes (77%) achieved the target IOP.                                        The most common complication was blockage of
The mean overall number of topical ocular hypoten-                                   the opening of the stent lumen, which occurred in
sive medications decreased significantly from 2.7 G                                  8 eyes in the early postoperative period. Stent block-
1.0 preoperatively to 0.7 G 1.1 medications at 1                                     age was successfully treated with a neodymium:YAG
year (P!.001) (Figure 1). The mean reduction at 1                                    laser or argon laser in 6 eyes and then repeated in 1 of
year was 2.0 G 1.4 medications, representing a 74%                                   these eyes. Laser treatment was not performed in
reduction. Forty-four patients (83%) reduced the                                     2 eyes because of good IOP control with a second pat-
number of medications at 1 year, and 31 (59%) dis-                                   ent stent in 1 eye and because the blockage was partial
continued use of all medications in the study eye.                                   in 1 eye.
The remaining eyes ended up on 1 medication (13                                         One eye presented with small hyphema 1 day post-
[24%]) or 2 or 3 medications (3 [6%] and 5 [9%], re-                                 operatively that resolved by 4 weeks postoperatively.
spectively); 1 eye was using 4 medications at 1 year.                                One of the stents in 1 eye was not seated well in the

                                                     J CATARACT REFRACT SURG - VOL 38, NOVEMBER 2012
1914                                             MULTIPLE TRABECULAR MICRO-BYPASS STENTS




 Table 1B. Preoperative characteristics.

 Parameter                                           Overall (N Z 53)        2-Stent Group (n Z 28)         3-Stent Group (n Z 25)        P Value

 Glaucoma, n (%)
   Primary open angle                                      37 (70)                    21 (75)                       16 (64)                  .55*
   Pseudoexfoliative                                       14 (26)                     7 (25)                        7 (28)                 1.00*
   Mixed mechanism                                          2 (4)                        0                           2 (8)
 Other ocular conditions, n (%)
   ARMD                                                     2   (4)                    4 (14)                          0
   High myopia                                              2   (4)                    1 (4)                          1 (5)
   Suprasellar lesion (treated with radiation)              2   (4)                    1 (4)                          1 (5)
   Branch vein occlusion                                    1   (2)                    1 (4)                           0
   Diabetic retinopathy                                     1   (2)                      0                            1 (4)
   ARMD scar                                                1   (2)                      0                            1 (4)
   Optic nerve head drusen                                  1   (0)                    1 (4)                           0
 Previous glaucoma procedures, n (%)
   LPI                                                     11 (21)                     4 (14)                        7 (28)                  .31*
   ALT                                                      9 (17)                     6 (21)                        3 (12)                  .47*
   SLT                                                     17 (32)                     7 (25)                       10 (40)                  .38*
   O1 previous procedure                                    8 (15)                     3 (11)                        5 (20)                  .45*
 Eye, n (%)                                                                                                                                  .42*
   Right                                                   24 (45)                    11 (39)                       13 (52)
   Left                                                    29 (55)                    17 (61)                       12 (48)
 CDVA, n (%)                                                                                                                                 .76†
   20/40 or better                                         14 (26)                     6 (21)                         8 (32)
   20/50–20/100                                            26 (49)                    15 (54)                        11 (44)
   20/200 or worse                                         13 (25)                     7 (25)                         6 (23)
 Mean C:D ratio G SD                                    0.74 G 0.16                0.76 G 0.16                    0.71 G 0.17                .23†
 Mean Shaffer grade G SD                                 2.9 G 0.7                  2.9 G 0.8                      2.8 G 0.6                 .93†
 Visual field
   Mean Deviation (dB) G SD                             À11.5 G 7.6                À12.6 G 7.1                    À10.2 G 8.1                .24†
   Mean pattern SD (dB) G SD                             6.9 G 3.8                  7.9 G 3.4                      5.9 G 4.1                 .06†
 Intraocular pressure
   Mean (mm Hg) G SD                                     18.0 G 4.0                 17.3 G 4.0                     18.6 G 4.0                .24†
   !15 mm Hg, n (%)                                        11 (21)                     6 (21)                         5 (20)
   15–18 mm Hg, n (%)                                      22 (42)                    13 (46)                         9 (36)
   O18 mm Hg, n (%)                                        20 (38)                     9 (32)                        11 (44)
 Target intraocular pressure
   Mean (mm Hg) G SD                                     16.2 G 2.1                 15.7 G 1.9                     16.7 G 2.3                .08†
   At or lower than target, n (%)                          23 (43)                    14 (50)                         9 (36)
 Medications
   Mean (n) G SD                                         2.7 G 1.0                   2.8 G 0.8                     2.6 G 1.2                 .70†
   1 medication                                             7 (13)                      2 (7)                         5 (20)
   2 medications                                          15 (28)                       8 (29)                        7 (28)
   3 medications                                          19 (36)                     13 (46)                         6 (24)
   O3 medications                                         12 (23)                       5 (18)                        7 (28)

 ALT Z argon laser trabeculoplasty; AMD Z age-related macular degeneration; C:D Z cup-to-disc ratio; CDVA Z corrected distance visual acuity; IOP Z
 intraocular pressure; LPI Z laser peripheral iridotomy; SLT Z selective laser trabeculoplasty
 *Fisher exact test
 †
   Two-sample t test




canal after surgery but was otherwise stable; thus, no                       Corrected Distance Visual Acuity
intervention was performed. A steroid response                                 Table 2 shows the CDVA at 1 year. One patient did
resulting in elevated IOP was identified at 5 weeks                          not have vision recorded at the final visit. Of the
in 1 eye and at 1 month in another eye. Both cases                           remaining 52 eyes, 47 (89%) had improved CDVA or
resolved once the steroids were discontinued. One                            maintained the preoperative CDVA. Of the 5 eyes
patient died from an unrelated systemic illness.                             with CDVA worsening at 1 year, 4 improved at

                                                 J CATARACT REFRACT SURG - VOL 38, NOVEMBER 2012
MULTIPLE TRABECULAR MICRO-BYPASS STENTS                                                      1915




Figure 1. Overall mean IOP (mm Hg) and number of glaucoma med-         Figure 2. Mean IOP (mm Hg) at each visit through 12 months strat-
ications from baseline through 12 months. Bars represent the stan-     ified by number of stents. Bars represent the standard deviation
dard deviation (IOP Z intraocular pressure).                           (IOP Z intraocular pressure).


subsequent visits. The remaining 1 patient was lost to                 requiring fewer medications. However, no attempt to
follow-up.                                                             reduce the number of medications preoperatively
                                                                       was made, potentially overestimating this effect.
DISCUSSION                                                             Compared with studies of implantation of a single
Samuelson et al.9 established that a single trabecular                 stent,8–11 use of multiple stents in this study resulted
bypass stent significantly reduced IOP and medication                  in a greater propensity to achieve a postoperative
burden at 1 year in patients having combined cataract–                 IOP of 15 mm Hg or less and a greater absolute reduc-
glaucoma implant procedures compared with patients                     tion in medications. This finding is consistent with the
having cataract surgery only. Studies by Fea8 and                      ex vivo work of Zhou and Smedley13 and Bahler
Spiegel et al.11 provide corroborating evidence of the                 et al.14 The use of multiple stents may exploit a greater
treatment effect of a single stent.                                    range of circumferential flow and allow access to
   In this open-label nonrandomized prospective se-                    a greater array of collector channels to establish phys-
ries, implantation of 2 or 3 trabecular bypass stents                  iologic flow of aqueous humor into the episcleral
in eyes having combined cataract surgery resulted in                   venous system.
significantly lower mean IOP at 1 year than preopera-                     Eyes in the 2-stent group had a significant reduction
tively (P!.001), with 77% of eyes achieving the post-                  in IOP and medications (P!.001 in all cases). Target
operative target pressure. This is despite no                          IOP was achieved in most cases (71%). Despite
preoperative medication washout period. The number                     a high mean preoperative medication burden in these
of glaucoma medications was also significantly                         moderate to advanced OAG patients, the majority
decreased from 2.7 medications preoperatively to 0.7                   (79%) had a reduced preoperative medication burden
medications at 1 year (P!.001), with 83% of eyes                       at 1 year. The IOP and number of medications also sig-
                                                                       nificantly decreased from preoperatively in the 3-stent
                                                                       group (P!.001); the target IOP was achieved by 84%
                                                                       compared with 43% preoperatively. There was a signif-
                                                                       icant reduction in medications, with 88% of eyes


                                                                         Table 2. Corrected distance visual acuity at 1 year.

                                                                                                             Number (%)

                                                                         CDVA                  Overall*   2-Stent Group*   3-Stent Group

                                                                         20/40 or better       37 (64)       18 (64)            19 (76)
                                                                         20/50–20/100          11 (21)        6 (21)             5 (20)
                                                                         20/200 or worse        4 (8)         3 (11)             1 (4)
Figure 3. The mean number of glaucoma medications used in each           CDVA Z corrected distance visual acuity
eye from baseline through month 12 stratified by number of stents.       *Missing 1
Bars represent the standard deviation (*PZ.009; 4PZ.04).


                                             J CATARACT REFRACT SURG - VOL 38, NOVEMBER 2012
1916                                    MULTIPLE TRABECULAR MICRO-BYPASS STENTS




requiring fewer medications and 72% of eyes on no                 invasive surgeries, such as trabeculectomy and tube
medications at 1 year. These data show high rates of              shunt placement, although this would have to be
IOP reduction and medication reduction with 2-stent               evaluated in a future prospective study.
or 3-stent implantation and the potential to achieve                 The data reported by Samuelson et al.9 suggest that
target IOP levels after multiple stent implantation.              a single stent implanted in combination with cataract
The significantly lower postoperative medication bur-             surgery achieves postoperative target pressures that
den in the 3-stent than in the 2-stent group suggests             are clinically meaningful for mild to moderate OAG
that stent titration is feasible. This allows the operating       patients with comorbid cataracts. For more moderate
surgeon to determine the appropriate number of stents             to advanced OAG patients with comorbid cataracts,
required to achieve the desired postoperative target              this study found that 2 or 3 stents implanted in com-
IOP. Furthermore, if necessary, it may allow the option           bined cataract procedures achieved mean IOPs that
of implanting additional micro-bypass devices in sub-             were clinically meaningful for these patients. There-
sequent procedures to optimize the benefit-to-risk                fore, single and multiple implants in combined cata-
ratio while preserving future management options.                 ract procedures may be preferable to the problems of
   No major surgical problems or postoperative com-               compliance (long-term morbidity and nonadherence)
plications were reported during the study. The most               associated with chronic use of multiple medications
common complication of a blocked stent by the iris                to control OAG. This may also improve patient conve-
was in most cases resolved by performing a laser iri-             nience and quality of life.
dotomy that was well tolerated by the patient. In                    The clinical utility and demonstrated efficacy and
some instances, no intervention was required because              safety of single and multiple stent implantation
the pressure was under control. The postoperative                 enables surgeons to select the implant therapy that is
hyphema resolved within the first month without                   most appropriate to achieve desired patient target
sequelae. Because of the nature of the insertion, mini-           pressures. This approach appears to offer a high
mal reflux of blood is an anticipated normal physio-              benefit-to-risk ratio for a given OAG disease stage
logic response immediately after stent implantation.              severity and desired postoperative target IOP.
Despite a poor preoperative CDVA in approximately
one fourth of these eyes with advanced glaucoma,
the CDVA improved or was maintained in most eyes                    WHAT WAS KNOWN
and most patients achieved a postoperative CDVA of                   Implantation of 1 trabecular micro-bypass stent combined
20/40 or better. These postoperative findings are sim-                with cataract surgery is safe and can more effectively
ilar to those reported by others.8–11,17                              reduce IOP and topical ocular hypotensive medication
   Further studies are needed to refine the relation-                 use compared with cataract surgery alone.
ship observed between the number of stents
implanted with concurrent cataract surgery and IOP
control. Determining the criteria for the number of                 WHAT THIS PAPER ADDS
stents to implant will also require further investiga-               The implantation of 2 or 3 trabecular micro-bypass stents
tion. Although the outcomes in the 2-stent group                      combined with cataract surgery was performed safely
and 3-stent group were similar, we attempted to se-                   with a reduction in IOP and topical ocular hypotensive
lect more severe patients for implantation of 3 stents.               medications.
However, our baseline analysis showed no signifi-
                                                                     Implantation of multiple trabecular micro-bypass stents
cant difference between the 2 groups in any measure.
                                                                      has the potential to further reduce IOP and topical ocular
Thus, a masked randomized trial is needed to better
                                                                      hypotensive medications versus implantation of 1 trabec-
evaluate the relative efficacy of 2 versus 3 stents. Fur-
                                                                      ular micro-bypass stent.
thermore, this series did not use a control group hav-
ing cataract surgery without stent implantation,
although previous studies8,9 established the benefit
of stent implantation and cataract surgery versus cat-            REFERENCES
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    115:1089–1098. Available at: http://www.amo-romania.com/             16. Canadian Ophthalmological Society evidence-based clinical
    Document_Files/Ophthalmology%202008%20Jun.115(6)%                        practice guidelines for cataract surgery in the adult eye. Can
    20p1089-98_AqueousShuntsinGlaucoma_vdcgv5.pdf.              Ac-          J Ophthalmol October 2008; 43(suppl 1):S7–S57. Available at:
    cessed July 17, 2012                                                     http://www.eyesite.ca/CJO/43S1/i08-133.pdf. Accessed July
 7. Jampel HD, Musch DC, Gillespie BW, Lichter PR, Wright MM,                17, 2012
    Guire KE; and the Collaborative Initial Glaucoma Treatment                                                       
                                                                         17. Fernandez-Barrientos Y, Garcia-Feijoo J, Mart       ınez-de-la-
    Study Group. Perioperative complications of trabeculectomy                                                                 
                                                                             Casa JM, Pablo LE, Fernandez-Perez C, Garcia Sanchez J.
    in the Collaborative Initial Glaucoma Treatment Study                    Fluorophotometric study of the effect of the Glaukos trabecular
    (CIGTS). Am J Ophthalmol 2005; 140:16–22. Available at:                  microbypass stent on aqueous humor dynamics. Invest Ophthal-
    http://new-glaucoma-treatments.com/wp-content/imagesfiles/               mol Vis Sci 2010; 51:3327–3332. Available at: http://www.iovs.
    Perioperative%20Complications%20of%20Trab%20CIGTS.                       org/content/51/7/3327.full.pdf. Accessed July 17, 2012
    pdf. Accessed July 17, 2012
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    micro-bypass stent implantation in primary open-angle glau-            A. Spiegel D, Garcia-Feijoo J, Martinez de la Casa JM, Garcia-
    coma: randomized double-masked clinical trial. J Cataract                 Sanchez J, GC-002 Study Group. iStent trabecular micro-
    Refract Surg 2010; 36:407–412                                             bypass and concurrent cataract surgery: 24 month results.
 9. Samuelson TW, Katz LJ, Wells JM, Duh Y-J, Giamporcaro JE;                 IOVS 2009; 50:E-Abstract 455. Abstract available at: http://
    for the US iStent Study Group. Randomized evaluation of the tra-          abstracts.iovs.org/cgi/content/abstract/50/5/455. Accessed
    becular micro-bypass stent with phacoemulsification in patients           July 17, 2012
    with glaucoma and cataract. Ophthalmology 2011; 118:459–467
10. Spiegel D, Garc                    ıa-S
                       ıa-Feijoo J, Garc anchez J, Lamielle H.
    Coexistent primary open-angle glaucoma and cataract: prelimi-
                                                                                                 First author:
    nary analysis of treatment by cataract surgery and the iStent
                                                                                                 Graham W. Belovay, MD
    trabecular micro-bypass stent. Adv Ther 2008; 25:453–464
                                            €         €
11. Spiegel D, Wetzel W, Neuhann T, Sturmer J, Hoh H, Garc      ıa-                             University of Toronto, Toronto,
    Feijoo J, Mart                           ıa-S
                   ınez-de-la-Casa JM, Garc anchez J. Coexis-                                   Ontario, Canada
    tent primary open-angle glaucoma and cataract: Interim analysis
    of a trabecular micro-bypass stent and concurrent cataract
    surgery. Eur J Ophthalmol 2009; 19:393–399




                                               J CATARACT REFRACT SURG - VOL 38, NOVEMBER 2012

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1 s2.0-s0886335012010061-main

  • 1. ARTICLE Using multiple trabecular micro-bypass stents in cataract patients to treat open-angle glaucoma Graham W. Belovay, MD, Abdulla Naqi, MD, Brian J. Chan, MD, Mahmoud Rateb, MD, Iqbal Ike K. Ahmed, MD PURPOSE: To evaluate the efficacy of multiple trabecular micro-bypass stents combined with cataract surgery in patients with open-angle glaucoma (OAG) and cataract. SETTING: Private practice, Mississauga, Ontario, Canada. DESIGN: Comparative case series. METHODS: Eyes with OAG had implantation of 2 or 3 micro-bypass stents with concurrent cataract surgery and follow-up through 1 year. Efficacy measures were intraocular pressure (IOP) and topical ocular hypotensive medication use. Safety assessment included complications and corrected distance visual acuity (CDVA). RESULTS: The study comprised 53 eyes (47 patients); 28 had implantation of 2 stents and 25 had implantation of 3 stents. The overall mean 1-year postoperative IOP was 14.3 mm Hg, which was significantly lower than preoperative IOP overall and in each group (P<.001). The target IOP was achieved in a significantly higher proportion of eyes at 1 year versus preoperatively (77% versus 43%; P<.001). Overall, 83% of eyes had a decrease in topical ocular hypotensive medication at 1 year from preoperatively, with a 74% decrease in the mean number of medications (from 2.7 to 0.7) at 1 year (P<.001). The 3-stent group was on significantly fewer medications than the 2-stent group at 1 year (0.4 versus 1.0; PZ.04). CONCLUSIONS: Using multiple micro-bypass stents with concurrent cataract surgery led to a mean postoperative IOP of less than 15 mm Hg and allowed patients to achieve target pressure control with significantly fewer medications through 1 year. Financial Disclosure: Dr. Ahmed is a consultant to Glaukos Corp. No other author has a financial or proprietary interest in any material or method mentioned. J Cataract Refract Surg 2012; 38:1911–1917 Q 2012 ASCRS and ESCRS Open-angle glaucoma (OAG) can be managed in sev- complications, including infection, corneal decompen- eral ways depending on the target intraocular pressure sation, choroidal hemorrhage, hypotony, diplopia, and (IOP), medication use, severity of glaucoma, quality of vision loss.1–7 Thus, despite their effective control of life, surgeon experience, and the surgical techniques IOP, they should not be considered benign operations. available. In general, newly diagnosed glaucoma is In the case of mild to moderate glaucoma and managed with medical therapy, possibly in combina- clinically significant cataract, less invasive surgical tion with laser trabeculoplasty. It is typically not until alternatives, such as microinvasive surgeries, can be the later stages of the disease when the patient is on performed in conjunction with cataract surgery. The maximum medical therapy that ab externo filtering use of less invasive treatments to reduce IOP and procedures are considered. glaucoma medications is a desirable approach to In the case of glaucoma and visually clinically signif- treating glaucoma, especially if this approach does icant cataract, combined cataract and glaucoma proce- not limit other options in the future. dures have been shown to not only lower IOP but to The iStent implant (Glaukos Corp.) is a trabecular also reduce the number of glaucoma medications.1–3 bypass device. It is the first of a class of new ab interno Unfortunately, traditional ab externo glaucoma devices that enables minimally invasive glaucoma surgical procedures (eg, trabeculectomy, tubes, deep surgery. Several studies have shown the effectiveness sclerectomy) are associated with significant risks and and safety of implanting this stent in eyes with mild to Q 2012 ASCRS and ESCRS 0886-3350/$ - see front matter 1911 Published by Elsevier Inc. http://dx.doi.org/10.1016/j.jcrs.2012.07.017
  • 2. 1912 MULTIPLE TRABECULAR MICRO-BYPASS STENTS moderate glaucoma to achieve this goal. Fea8 and Preoperatively, demographic information (age, sex, and Samuelson et al.9 compared phacoemulsification race), ocular history (including type of glaucoma), glaucoma medications, and results from a recent visual field were with and without stent implantation and found that recorded. The preoperative ocular examination included the combined surgery was more effective at control- Snellen corrected distance visual acuity (CDVA), IOP ling IOP than cataract surgery alone; the safety profiles (Goldmann applanation tonometry [GAT]), cup-to-disc ratio, of both groups were similar. Spiegel et al.10,11,A stud- anterior chamber angle (Shaeffer grade), and lens opacity grade ied stent implantation with concurrent cataract (Lens Opacity Classification III15). Target IOP and the stage of glaucoma were determined using the Canadian Ophthalmo- surgery in glaucoma patients and found effective logical Society evidence-based clinical practice guidelines for IOP control through 24 months (16.9 mm Hg versus the management of glaucoma in the adult eye.16 Patients 21.9 mm Hg preoperatively). Also, medication use with a remote history of angle-closure glaucoma requiring laser was reduced (0.4 versus 1.4 preoperatively). None of peripheral iridotomy and open angles at the time of surgery these studies reports major surgical complications. were classified as mixed mechanism. Ocular hypotensive medications were not discontinued before surgery. Earlier work12 suggests that more advanced OAG Using the technique described by Spiegel et al.,10 the same patients may require postoperative target pressures surgeon (I.I.K.A.) implanted 2 or 3 iStents in the eye after of 15 mm Hg or less to prevent further glaucomatous phacoemulsification. The stents were inserted in the nasal re- progression. Studies of the trabecular bypass stent by gion of the trabecular meshwork separated by 1 to 2 clock Zhou and Smedley13 and Bahler14 addressed this hours. Eyes requiring greater IOP control (ie, to achieve the target IOP) as determined by the operating surgeon received lower threshold. They established a theoretical in vitro 3 stents instead of 2 stents. Intraoperatively, the type of intra- perfusion model that predicted that multiple ocular lens, the number of stents implanted, and the compli- trabecular stents may increase facility of outflow and cations were recorded. reduce IOP versus a single implant. Bahler et al.14 Postoperatively, patients were seen at 1 day, 1 week, and found that subsequent placement of a second stent 1, 3, 6, and 12 months. Snellen visual acuity, IOP (with GAT), glaucoma medications, stent placement using gonioscopy, reduced the mean IOP by an additional 3.6 mm Hg and complications were assessed at these visits by the exam- in 7 of 9 enucleated cadaver eyes. ining physician. The examiners were not masked to the num- The current study evaluated the effects of multiple ber of stents. The number of ocular hypotensive medications trabecular micro-bypass stents in combination with was reduced gradually based on the postoperative IOP tar- cataract surgery on IOP and glaucoma medication get in each case. Statistical analyses were performed using SPSS software use in patients with OAG and concurrent cataract. (version 15, International Business Machines Corp.) in an intent-to-treat analysis. A paired t test was used to determine the significance of the change in IOP and glaucoma medica- PATIENTS AND METHODS tions from baseline to 12 months. A 2-sample t test was used to compare the IOP and glaucoma medications between each This was an open-label nonrandomized prospective single- time point and each stent group. A Mann-Whitney test was center series of eyes with OAG that had implantation of performed to compare outcomes between the 2-stent group 2 or 3 trabecular micro-bypass stents with concurrent cata- and the 3-stent group. Demographic data were compared be- ract surgery. Key inclusion criteria were visually significant tween groups using a 2-sample t test or Fisher exact test. Sig- cataract, IOP that was not well controlled on medication or nificance was set at 5%. was well controlled but with a substantial (R3) medication burden, and follow-up through 12 months postoperatively. Ethics approval was obtained from IRB Services, Ltd., Au- rora, Ontario, Canada, and all patients provided informed RESULTS consent. The study enrolled 53 eyes of 47 patients. Table 1A shows the patients’ demographics and Table 1B, the Submitted: November 29, 2011. preoperative characteristics. All eyes had cataract Final revision submitted: July 3, 2012. requiring surgery. Glaucoma diagnoses at time of sur- Accepted: July 6, 2012. gery included primary OAG, pseudoexfoliative, and mixed mechanism. Previous glaucoma surgeries From the University of Toronto (Belovay, Naqi, Rateb, Ahmed), included laser peripheral iridotomy, argon laser trabe- Toronto, Ontario and McMaster University (Chan), Hamilton, Ontario, Canada; University of Utah (Ahmed), Salt Lake City, Utah, USA. culoplasty (ALT), and selective laser trabeculoplasty (SLT). Eight eyes had 2 procedures (laser peripheral Presented in part at the American Glaucoma Society Meeting, San iridotomy and ALT, n Z 1; laser peripheral iridotomy Diego, California, USA, March 2010, and at the ASCRS Symposium and SLT, n Z 4; ALT and SLT, n Z 3). Those with laser on Cataract, IOL and Refractive Surgery, Boston, Massachusetts, peripheral iridotomies, with the exception of the mixed- USA April 2010. mechanism patients, had the procedures performed by Corresponding author: Iqbal Ike K. Ahmed, MD, Credit Valley their referring physicians for reasons unknown. No eye EyeCare, 3200 Erin Mills Parkway, Unit 1, Mississauga, Ontario, had a history of trabeculectomy or shunt implantation. L5L 1W8, Canada. E-mail: ike.ahmed@utoronto.ca. Approximately half the eyes had a preoperative CDVA J CATARACT REFRACT SURG - VOL 38, NOVEMBER 2012
  • 3. MULTIPLE TRABECULAR MICRO-BYPASS STENTS 1913 Table 1A. Demographics. Parameter Overall (N Z 47)* 2-Stent Group (n Z 26) 3-Stent Group (n Z 23) P Value Mean age (y) G SD 77.2 G 7.4 78.8 G 7.0 75.0 G 7.3 .07† Sex, n (%) .54z Male 14 (30) 7 (27) 9 (39) Female 33 (70) 19 (73) 14 (61) Race, n (%) .43x White 29 (62) 18 (69) 11 (48) Black 7 (15) 4 (15) 4 (17) South Asian 7 (15) 2 (8) 5 (22) Far East Asian 4 (8) 2 (8) 3 (13) *Two patients received 2 stents in 1 eye and 3 stents in the other eye † Two-sample t test z Fisher exact test x Fisher exact test with Monte Carlo simulation of 20/50 to 20/100, with the remainder having a CDVA Intraocular Pressure and Medications by Stent Group of 20/40 or better or 20/200 or worse. Eight eyes had The 1-year IOP was significantly lower than the mild glaucoma, 23 had moderate glaucoma, and 22 preoperative IOP in the 2-stent group (mean had advanced glaucoma. 13.8 mm Hg postoperatively) and the 3-stent group Of the 53 eyes, 28 had implantation of 2 stents and (mean 14.8 mm Hg postoperatively) (both P!.001) 25 had implantation of 3 stents. Forty-one patients (Figure 2). There was no significant difference in IOP (87%) had 2 or 3 stents implanted in 1 eye only. Two reduction between the 2 groups (PZ.78). Twenty- patients received 3 stents bilaterally, 2 received 2 stents one eyes (75%) in the 2-stent group achieved a 1-year bilaterally, and 2 received 2 stents in 1 eye and 3 stents postoperative IOP of 15 mm Hg or less. The IOP reduc- in the other eye. tion was greater in the 3-stent group, with a mean The mean preoperative medicated IOP was similar reduction of 3.9 mm Hg versus 3.5 mm Hg in the between the 2-stent group and the 3-stent group. Over- 2-stent group (PZ.76). Target IOP was achieved by all preoperatively, fewer than half the eyes were at the 20 eyes (71%) in the 2-stent group and 21 eyes (84%) target IOP levels. in the 3-stent group. The mean number of topical ocu- The mean number of preoperative medications was lar hypotensive medications significantly decreased to similar between the 2-stent group and the 3-stent 1.0 medication and 0.4 medication, respectively, at group. More eyes in the 3-stent group than in the 1 year (P!.001) (Figure 3), representing a 64% reduc- 2-stent group were taking 4 or more medications. tion in medications in the 2-stent group and 85% reduction in the 3-stent group. The 3-stent group was Overall Intraocular Pressure and Medications on significantly fewer medications at 1 year than the Overall, the decrease in the mean IOP from preop- 2-stent group (PZ.04). At 1 year, medication use had eratively (18.0 G 4.0 mm Hg) to 1 year postopera- been stopped in 13 eyes (46%) in the 2-stent group tively (14.3 G 2.9 mm Hg) was statistically and 18 eyes (72%) in the 3-stent group. significant (P!.001) (Figure 1). Thirty-seven eyes (70%) achieved an IOP of 15 mm Hg or less at 1 Complications year, and 41 eyes (77%) achieved the target IOP. The most common complication was blockage of The mean overall number of topical ocular hypoten- the opening of the stent lumen, which occurred in sive medications decreased significantly from 2.7 G 8 eyes in the early postoperative period. Stent block- 1.0 preoperatively to 0.7 G 1.1 medications at 1 age was successfully treated with a neodymium:YAG year (P!.001) (Figure 1). The mean reduction at 1 laser or argon laser in 6 eyes and then repeated in 1 of year was 2.0 G 1.4 medications, representing a 74% these eyes. Laser treatment was not performed in reduction. Forty-four patients (83%) reduced the 2 eyes because of good IOP control with a second pat- number of medications at 1 year, and 31 (59%) dis- ent stent in 1 eye and because the blockage was partial continued use of all medications in the study eye. in 1 eye. The remaining eyes ended up on 1 medication (13 One eye presented with small hyphema 1 day post- [24%]) or 2 or 3 medications (3 [6%] and 5 [9%], re- operatively that resolved by 4 weeks postoperatively. spectively); 1 eye was using 4 medications at 1 year. One of the stents in 1 eye was not seated well in the J CATARACT REFRACT SURG - VOL 38, NOVEMBER 2012
  • 4. 1914 MULTIPLE TRABECULAR MICRO-BYPASS STENTS Table 1B. Preoperative characteristics. Parameter Overall (N Z 53) 2-Stent Group (n Z 28) 3-Stent Group (n Z 25) P Value Glaucoma, n (%) Primary open angle 37 (70) 21 (75) 16 (64) .55* Pseudoexfoliative 14 (26) 7 (25) 7 (28) 1.00* Mixed mechanism 2 (4) 0 2 (8) Other ocular conditions, n (%) ARMD 2 (4) 4 (14) 0 High myopia 2 (4) 1 (4) 1 (5) Suprasellar lesion (treated with radiation) 2 (4) 1 (4) 1 (5) Branch vein occlusion 1 (2) 1 (4) 0 Diabetic retinopathy 1 (2) 0 1 (4) ARMD scar 1 (2) 0 1 (4) Optic nerve head drusen 1 (0) 1 (4) 0 Previous glaucoma procedures, n (%) LPI 11 (21) 4 (14) 7 (28) .31* ALT 9 (17) 6 (21) 3 (12) .47* SLT 17 (32) 7 (25) 10 (40) .38* O1 previous procedure 8 (15) 3 (11) 5 (20) .45* Eye, n (%) .42* Right 24 (45) 11 (39) 13 (52) Left 29 (55) 17 (61) 12 (48) CDVA, n (%) .76† 20/40 or better 14 (26) 6 (21) 8 (32) 20/50–20/100 26 (49) 15 (54) 11 (44) 20/200 or worse 13 (25) 7 (25) 6 (23) Mean C:D ratio G SD 0.74 G 0.16 0.76 G 0.16 0.71 G 0.17 .23† Mean Shaffer grade G SD 2.9 G 0.7 2.9 G 0.8 2.8 G 0.6 .93† Visual field Mean Deviation (dB) G SD À11.5 G 7.6 À12.6 G 7.1 À10.2 G 8.1 .24† Mean pattern SD (dB) G SD 6.9 G 3.8 7.9 G 3.4 5.9 G 4.1 .06† Intraocular pressure Mean (mm Hg) G SD 18.0 G 4.0 17.3 G 4.0 18.6 G 4.0 .24† !15 mm Hg, n (%) 11 (21) 6 (21) 5 (20) 15–18 mm Hg, n (%) 22 (42) 13 (46) 9 (36) O18 mm Hg, n (%) 20 (38) 9 (32) 11 (44) Target intraocular pressure Mean (mm Hg) G SD 16.2 G 2.1 15.7 G 1.9 16.7 G 2.3 .08† At or lower than target, n (%) 23 (43) 14 (50) 9 (36) Medications Mean (n) G SD 2.7 G 1.0 2.8 G 0.8 2.6 G 1.2 .70† 1 medication 7 (13) 2 (7) 5 (20) 2 medications 15 (28) 8 (29) 7 (28) 3 medications 19 (36) 13 (46) 6 (24) O3 medications 12 (23) 5 (18) 7 (28) ALT Z argon laser trabeculoplasty; AMD Z age-related macular degeneration; C:D Z cup-to-disc ratio; CDVA Z corrected distance visual acuity; IOP Z intraocular pressure; LPI Z laser peripheral iridotomy; SLT Z selective laser trabeculoplasty *Fisher exact test † Two-sample t test canal after surgery but was otherwise stable; thus, no Corrected Distance Visual Acuity intervention was performed. A steroid response Table 2 shows the CDVA at 1 year. One patient did resulting in elevated IOP was identified at 5 weeks not have vision recorded at the final visit. Of the in 1 eye and at 1 month in another eye. Both cases remaining 52 eyes, 47 (89%) had improved CDVA or resolved once the steroids were discontinued. One maintained the preoperative CDVA. Of the 5 eyes patient died from an unrelated systemic illness. with CDVA worsening at 1 year, 4 improved at J CATARACT REFRACT SURG - VOL 38, NOVEMBER 2012
  • 5. MULTIPLE TRABECULAR MICRO-BYPASS STENTS 1915 Figure 1. Overall mean IOP (mm Hg) and number of glaucoma med- Figure 2. Mean IOP (mm Hg) at each visit through 12 months strat- ications from baseline through 12 months. Bars represent the stan- ified by number of stents. Bars represent the standard deviation dard deviation (IOP Z intraocular pressure). (IOP Z intraocular pressure). subsequent visits. The remaining 1 patient was lost to requiring fewer medications. However, no attempt to follow-up. reduce the number of medications preoperatively was made, potentially overestimating this effect. DISCUSSION Compared with studies of implantation of a single Samuelson et al.9 established that a single trabecular stent,8–11 use of multiple stents in this study resulted bypass stent significantly reduced IOP and medication in a greater propensity to achieve a postoperative burden at 1 year in patients having combined cataract– IOP of 15 mm Hg or less and a greater absolute reduc- glaucoma implant procedures compared with patients tion in medications. This finding is consistent with the having cataract surgery only. Studies by Fea8 and ex vivo work of Zhou and Smedley13 and Bahler Spiegel et al.11 provide corroborating evidence of the et al.14 The use of multiple stents may exploit a greater treatment effect of a single stent. range of circumferential flow and allow access to In this open-label nonrandomized prospective se- a greater array of collector channels to establish phys- ries, implantation of 2 or 3 trabecular bypass stents iologic flow of aqueous humor into the episcleral in eyes having combined cataract surgery resulted in venous system. significantly lower mean IOP at 1 year than preopera- Eyes in the 2-stent group had a significant reduction tively (P!.001), with 77% of eyes achieving the post- in IOP and medications (P!.001 in all cases). Target operative target pressure. This is despite no IOP was achieved in most cases (71%). Despite preoperative medication washout period. The number a high mean preoperative medication burden in these of glaucoma medications was also significantly moderate to advanced OAG patients, the majority decreased from 2.7 medications preoperatively to 0.7 (79%) had a reduced preoperative medication burden medications at 1 year (P!.001), with 83% of eyes at 1 year. The IOP and number of medications also sig- nificantly decreased from preoperatively in the 3-stent group (P!.001); the target IOP was achieved by 84% compared with 43% preoperatively. There was a signif- icant reduction in medications, with 88% of eyes Table 2. Corrected distance visual acuity at 1 year. Number (%) CDVA Overall* 2-Stent Group* 3-Stent Group 20/40 or better 37 (64) 18 (64) 19 (76) 20/50–20/100 11 (21) 6 (21) 5 (20) 20/200 or worse 4 (8) 3 (11) 1 (4) Figure 3. The mean number of glaucoma medications used in each CDVA Z corrected distance visual acuity eye from baseline through month 12 stratified by number of stents. *Missing 1 Bars represent the standard deviation (*PZ.009; 4PZ.04). J CATARACT REFRACT SURG - VOL 38, NOVEMBER 2012
  • 6. 1916 MULTIPLE TRABECULAR MICRO-BYPASS STENTS requiring fewer medications and 72% of eyes on no invasive surgeries, such as trabeculectomy and tube medications at 1 year. These data show high rates of shunt placement, although this would have to be IOP reduction and medication reduction with 2-stent evaluated in a future prospective study. or 3-stent implantation and the potential to achieve The data reported by Samuelson et al.9 suggest that target IOP levels after multiple stent implantation. a single stent implanted in combination with cataract The significantly lower postoperative medication bur- surgery achieves postoperative target pressures that den in the 3-stent than in the 2-stent group suggests are clinically meaningful for mild to moderate OAG that stent titration is feasible. This allows the operating patients with comorbid cataracts. For more moderate surgeon to determine the appropriate number of stents to advanced OAG patients with comorbid cataracts, required to achieve the desired postoperative target this study found that 2 or 3 stents implanted in com- IOP. Furthermore, if necessary, it may allow the option bined cataract procedures achieved mean IOPs that of implanting additional micro-bypass devices in sub- were clinically meaningful for these patients. There- sequent procedures to optimize the benefit-to-risk fore, single and multiple implants in combined cata- ratio while preserving future management options. ract procedures may be preferable to the problems of No major surgical problems or postoperative com- compliance (long-term morbidity and nonadherence) plications were reported during the study. The most associated with chronic use of multiple medications common complication of a blocked stent by the iris to control OAG. This may also improve patient conve- was in most cases resolved by performing a laser iri- nience and quality of life. dotomy that was well tolerated by the patient. In The clinical utility and demonstrated efficacy and some instances, no intervention was required because safety of single and multiple stent implantation the pressure was under control. The postoperative enables surgeons to select the implant therapy that is hyphema resolved within the first month without most appropriate to achieve desired patient target sequelae. Because of the nature of the insertion, mini- pressures. This approach appears to offer a high mal reflux of blood is an anticipated normal physio- benefit-to-risk ratio for a given OAG disease stage logic response immediately after stent implantation. severity and desired postoperative target IOP. Despite a poor preoperative CDVA in approximately one fourth of these eyes with advanced glaucoma, the CDVA improved or was maintained in most eyes WHAT WAS KNOWN and most patients achieved a postoperative CDVA of Implantation of 1 trabecular micro-bypass stent combined 20/40 or better. These postoperative findings are sim- with cataract surgery is safe and can more effectively ilar to those reported by others.8–11,17 reduce IOP and topical ocular hypotensive medication Further studies are needed to refine the relation- use compared with cataract surgery alone. ship observed between the number of stents implanted with concurrent cataract surgery and IOP control. Determining the criteria for the number of WHAT THIS PAPER ADDS stents to implant will also require further investiga- The implantation of 2 or 3 trabecular micro-bypass stents tion. Although the outcomes in the 2-stent group combined with cataract surgery was performed safely and 3-stent group were similar, we attempted to se- with a reduction in IOP and topical ocular hypotensive lect more severe patients for implantation of 3 stents. medications. However, our baseline analysis showed no signifi- Implantation of multiple trabecular micro-bypass stents cant difference between the 2 groups in any measure. has the potential to further reduce IOP and topical ocular Thus, a masked randomized trial is needed to better hypotensive medications versus implantation of 1 trabec- evaluate the relative efficacy of 2 versus 3 stents. Fur- ular micro-bypass stent. thermore, this series did not use a control group hav- ing cataract surgery without stent implantation, although previous studies8,9 established the benefit of stent implantation and cataract surgery versus cat- REFERENCES aract surgery only. The 6 cases of bilateral implanta- 1. Funnell CL, Clowes M, Anand N. 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