Kamra

Presbyopia Concept
 Presbyopic patients often believe that the gradual loss of near
vision represents a visual impairment that will degrade the
quality of their lives.
 In actuality, the inevitable loss of accommodative power in
human visual systems begins as early as infancy, with virtually
everyone fully realizing its adverse effects by 50 years of age.

Presbyopia Concept
 Presbyopia can be a shocking and frustrating occurrence in the
busy, productive, and fulfilling lives of today's patients
 Presbyopia has historically been a challenge for
ophthalmologists as well, due to the limited number of optimal
solutions for treatment that were previously available.

Presbyopia Market
 The global market for presbyopia currently includes 1.7 billion
people—typically between the ages of 40 and 60 years—and it is
expected to increase to 2.1 billion by 2020
 The projected magnitude of this phenomenon underlies the
attention devoted to pursuing innovative surgical approaches to
manage this treatable condition.
 Recent data show that people between the ages of 47 and 65 years
represent nearly 50% of all consumer spending, and the spending
power of those over age 50 years is estimated to be in the trillions by
2015

Presbyopia Market & U.S. Statistics
 80 million baby boomers began turning 60 in 2006
 In 2012 43 million > age of 65
 By 2020 will increase to 55 million > 65
 By 2025 ~ 60% of US population > 55
 Over 50% > age 65 have visually significant cataracts
 Currently estimated that cataracts affect > 22 million in US
Currently 3 million+ cataract surgeries per year in US
That number is expected to increase to > 30 million by 2020

Presbyopia Market & U.S. Statistics
 Incidence of cataract surgery dramatically increasing
• Improved access to surgery
• More surgeons
• Adoption of widening indications for surgery
 Between 1998–2004 28% of patients had 2nd eye sx by 90 d
 Between 2005-2011 increased to 60%

Surgical Presbyopia Options
 Monovision
 LASIK and PRK
 CK (Conductive Keratoplasty) Has FDA approval
 Monofocal ICLs
 Monofocal IOLs
 Multifocal Implants (PC-IOLs) On the horizon
 Multiple new designs of PC-IOLs
 Multifocal excimer ablations – presbyLASIK
 Corneal inlays
○ Kamra ( AcuFocus , Inc., Irvine, CA)
○ Raindrop (formerly Vue+, PresbyLens; ReVision Optics, Inc. Lake Forest, CA),)
○ Flexivue Microlens (Presbia Coöperatief UA, Amsterdam, Netherlands)

Inlay Concept
 The concept behind intracorneal implants is not new;it has been reported on since
the late i1940s,and Professor José Barraquer s generally credited with the original
idea
 These inlays were originally used to treat Fuchs dystrophy, high myopia, and
aphakia, but the materials were neither optically ideal nor permeable.
 Common problems with earlier iterations of the technology included
 Decentration,
 Kertolysis, and
 Opacification.
 But modern designs are highly permeable, and they have small diameters and thin
profiles.
 Surgical technique has been modified, because centration is now recognized as
critical to the devices’ proper performance

Corneal Inlays
 Corneal inlays are small artificial implants that are inserted into the
cornea via either a femtosecond laser-created pocket or corneal flap to
alter the optics of the eye and improve near vision.
 Several inlays are in development or in use globally but are unavailable
in the United States, including
 Raindrop (formerly Vue+ ,PresbyLens; ReVision Optics, Inc. Lake Forest, CA),
 Flexivue Microlens (Presbia Coöperatief UA, Amsterdam, Netherlands)
 Kamra (AcuFocus, Inc., Irvine, CA).

Flexivue Micro-lens (Presbia)
KAMRA(Formerly ACI 7000) (Acufocus)
Raindrop (Formerly VUE+ ,Presbylens) (ReVision)
Corneal Inlays

Flexivue Micro-Lens
(Presbia)
KAMRA
(formerly ACI 7000)
(Acufocus)
Vue+
(formerly Presbylens)
(ReVision)
Procedure Modified monovision Modified monovision Modified monovision
Mechanism of action Changes the refractive index Increases the depth of focus Changes the anterior corneal curvature
Surgery Pocket Flap or Pocket Flap
Stromal Depth 280-300 microns 200 microns 120 microns
Biocompatible YES YES YES
Inlay Thickness 15-20 microns 10 microns 20-40 microns
Diameter 3.2 mm 3.8 mm 2 mm
Nutrient flow
YES
(Central hole)
YES (Micropores)
Yes
(Hydrogel permeable material)
FDA Approved
NO
(Clinical trials)
NO
(Phase III)
NO
(Clinical trials)
CE Mark YES YES YES
INLAYS CHARACHTERISTICS

The Raindrop inlay (Corneal Reshaping Inlays)
 A 2-mm hydrogel corneal implant indicated for the correction of presbyopia.
 Its functionality is based on the principle of multifocality.
 is 30 µm thick under a 130 -to 150 μm LASIK flap is designed to change the curvature
of the central cornea of one eye to add near and intermediate focusing power.
 The implant is removable.
 Is in US clinical trials, has CE Mark approval, and is available for sale in Europe.
 Six-month data on 34 patients who received the implant were
 The mean uncorrected near visual acuity in the implanted eyes was J1 (ie, a 4-line
improvement).
 Intermediate visual acuity improved by a mean of 2 lines, and
 distance visual acuity decreased by a mean of 1.5 lines.
 Binocularly, no patient saw worse than 20/25.

15
Inlay Thickness
30 µm Flap Bed
Bowman’s
Layer
Stromal Cushion
100 µm
Inlay has same refractive index as cornea but
increases curvature in the center of the pupil
The Raindrop inlay (Corneal Reshaping Inlays) How It Works

The Raindrop inlay (Corneal Reshaping Inlays)

MicroLens Flexivue
 Hydrogel corneal microlens implanted after creating a
femtosecond flap
 Restores near and intermediate vision in patients with
myopic, hyperopic, and emmetropic presbyopia
 Transparent, biocompatible and mimics a healthy
cornea
 Removal with reversible vision
17
2 mmdiameter, ~30 μmthickness VUE+ Inlay

MicroLens Flexivue
 The Flexivue MicroLens is a refractive corneal inlay based on the multifocal (bifocal)
principle.
 This removable inlay is 3 mm wide, is approximately 15 µm thick, 0.15 mm opening in
the center to facilitate fluid and nutrient flow.and is made of a hydrophilic polymer.
 add power from +1.25 to +3.5 D, in 0.25D steps
 implantation in a corneal pocket at a depth of 280 -300
 Recent studies of the Flexivue Microlens lens performed by Ioannis Pallikaris,
 Postoperative uncorrected near visual acuity was 20/25 or better in 77% of the patients.
 Ninety-two percent of the patients did not use reading glasses, and 8% used reading glasses
for less than half of their near activities after surgery.
 Of the patients with 15 months' follow-up, 77% saw 20/16 at near, and their operative eye
showed a slight decrease in distance vision.

MicroLens Flexivue( how it works)
 Bifocal design produces two images at the Foveal level
 one image results from the combined refractive effects of area of
the cornea that surrounds the lens and the central zone of the
lens
 one image from the peripheral zone of the lens
 Neuroadaptation aids in using both images by choice
 Disadvantag
 pupil smaller than 3.0 mm = the peripheral plus power of the
lens obstructed by iris

Microlens Flexivue iTrace wavefront analysis
UDVA: 20/25, J1
Slit lampphoto and eye imagetaken fromthe
iTrace.
Inlaycenteredon visual axis-coincideswith pupil
center
Refractivemapof totalocularaberrationsin
theareaof theinlay. Theinlay’speripheral
partcreatesa myopiceffectwhilstthecentral
partremainsemmetropic

Microlens Setting of the laser parameters iFS 150
 iPockets software
– Depth: 280-300
– Diameter: 4 mm
– Bed energy: 0.60-0,70
– Spot-LineSep: 2-2 (or 3-3)
– Side cut energy: 1.6-1.7
– Side cut angle: 160

Kamra inlay
 The Kamra inlay has CE Mark approval and is in US IDE clinical trials for the
treatment of presbyopia.
 Unlike the other implants described herein, the Kamra inlay utilizes small-aperture
optics to increase the depth of focus by allowing only focused light rays to enter the
eye.
 As a result, the inlay continues to provide near vision as the crystalline lens loses its
accommodative function.
 The inlay is commercially available in Europe, Asia, Latin America, and the Middle
East.
 It is placed in a stromal pocket or under a lamellar flap. The pocket procedure was
used for the 507 emmetropic patients in the manufacturer's current US study,
conducted under an IDE. If necessary, patients who receive the Kamra inlay can
have it removed, and their vision will reportedly revert to base-line
 In the clinical trial, on average, patients achieved J2 to J3 for near and maintained
good distance vision at 20/20 out to 18 months .

KAMRA Corneal Inlay
 3.8mm Diameter 5 Microns Thick - 1/10th the Thickness of a Sheet of Paper
 (7.5 mm radius), and flexible enough to bend to different curvatures without Buckling
 Mass is 71-142 micrograms - about the Weight of a Salt Crystal
 The opaque annulus is incorporated with black carbon particles and has 8,400
perforations of various sizes distributed in random arrangement.
 This is designed to counter diffraction issues under mesopic settings and yet allow
nutrient flow and approximately 10% additional light transmission beyond those
passing through the center aperture
 KAMRA inlay is estimated to provide presbyopic corrective equivalence of up to
+2.00D.8

Kamra Inlay Design
8,400
micro-perforations(5-11µ)
Pseudo-random
pattern
Maximize nutrient
flow
Minimize visual
symptoms

Kamra Inlay approval
 The KAMRA™ inlay received CE mark for use in the European
Union in 2005 and is now approved in 49 countries worldwide.
The KAMRA inlay is an investigational device, limited under
federal (U.S.) law to investigational use and is not available for
sale in the United States.

Kamra Inlay Optical Principals
 Light Rays Pass through the Small Aperture Over a Small Angle,
Increasing the Depth of Focus by permitting central image rays to project
onto retina while obscuring the transmission of peripheral light rays.
 Because peripheral rays create larger blur circles at the retinal plane,
improved depth of focus and image resolution will occur when only central
incident rays are transmitted
 Distance Vision is Minimally Affected
3.8mm diameter
1.6mm mm

Kamra inlay (Treating A Broad Spectrum Of Patients)
 The inlay can be inserted on its own, in combination with
other refractive procedures, or as an enhancement to prior
cataract or refractive surgery.

Kamra inlay (Treating A Broad Spectrum Of Patients)

Kamra Inlay ( range of correction)

Exclusion Criteria
 Prior corneal procedures (Except LASIK and PRK)
 Any ocular or systemic disease that is a contraindication for
 corneal refractive procedures including:
 Keratoconus
 Uncontrolled and/or severe dry eye
 Cataracts
 Macular degeneration
 Corneal dystrophy or degeneration
 Amblyopia or Strabismus
 Patients with unrealistic expectations
 Patients with psychological conditions

 The KAMRA inlay is inserted unilaterally into the patient’s
non-dominant eye in a corneal pocket and is centered over
the visual axis.
 Since the inlay works based on small aperture optics rather
than change in refractive power,improved near vision
results remain immune to the progression of presbyopia,
offering patients a lifetime of benefis.

Acutarget (a device for centration check)

Acutarget ( need for it )
 Remarkable axes of the eye are due to one of its peculiarities:
 lack of a common axis for main refractive structures (ie, cornea and lens).
 In addition, the fovea is slightly temporal to the emergence of the optic nerve.
 Some axes have a
 functional value (eg, visual axis or line of sight), whereas others have a
primarily
 anatomical value (eg,pupil axis).
 The angle kappa is between the pupil and visual axes, whereas the
angle lambda is between the pupil axis and
line of sight.
 Both angles are nearly identical if the point of fiation is not close to the
eye

Acutarget ( need for it )
 Where to center corneal refractive procedures to maximize visual outcomes remains
controversial
 The pupil center is often a reference for refractive procedures. However, corneal light
reflx may be better because it may lie nearer to the corneal intercept of the visual axis
than the pupil center.
 Furthermore, compensation for angle kappa is important for optimal correction of
refractive error by either laser ablation or intraocular lenses, especially for hyperopes and
any eyes with large angle kappa.
 The AcuTarget (SensoMotoric Instruments, Teltow, Germany) is new and helps identify
both the corneal vertex and pupil center.
 It can be used to guide surgeons on proper surgical placement of intracorneal small
aperture inlays, which are new treatment options for presbyopia.
 It can also be used for cataract surgery to determine precise placement of a toric
intraocular lens

Comprehensive Diagnostic & Surgical Planning
 With the AcuTarget HD™ you have the powerhouse of
fit separate diagnostictools combined intoone state-of-the-art
instrument. It’s designed to optimize clinical outcomes by:
• Providing objective and reliable measurements to ensure you
are targeting the right patients
• Identifying unique optical landmarks to assist with inlay
centration planning
• Supporting the management of patient care post-operatively

 The AcuTarget HD helps identify factors that may impact
visual outcomes by:
• Evaluating the quality of vision, including objective scatter
index(OSI), which is usually unaccounted for by wavefront
aberrometers
• Assessing tear fim quality over time
• Measuring pseudo accommodation to visually demonstrate
depth-of-focus

Acutarget(assesing OSI)(simulation for patient)

Acutarget(assesing Tear Film)(perop and postop)

Acutarget(assesing centration)(preop & postop)

 As with other refractive procedures, achieving the best possible
visual outcomes with the small-aperture KAMRA™ inlay requires
precise pre-operative testing, centration and post-operative
monitoring. The AcuTarget HD™ delivers reliable and repeatable
diagnostic information unique to each patient by:
 • Capturingthe patient’s estimated line of sight based on
1st Purkinje reflx, pupil boundary and pupil centroid
 • Pinpointing the exact inlay position relative to the 1st Purkinje
reflx, pupil center, pupil boundary and limbus
 • Reportingactual inlay placement in microns
 • Offering real-time information to help manage the patient’s care

Acutarget(assesing centration )(Perop)
 To determine the centration target, the surgeon first runs the preoperative diagnostics
and planning feature of the diagnostic unit.
 The system
 captures an image of the eye,
 identifies important landmarks with colored rings and crosses, and
 displays the distance and direction between the first Purkinje image and the pupil
centroid.
 The system also
 calculates the distance (in terms of cord length) of the inlay to the center of the
pupil.
○ If the distance is <300 μm, then the inlay should be centered on the first Purkinje
image, and
○ if it is longer than 300 μm, then the inlay is centered between the first Purkinje
image and the pupil centroid.

Kamra Inlay Surgical Procedure
Pocket Flap

Kamra Inlay Surgical Procedure

Kamra Inlay (femtosecond laser setting

Acutarget(assesing centration )(intraop)
 Intraoperatively, the surgeon marks the eye to guide placement
of the inlay.
 Different techniques can be used for this step. For example,
 surgeons who have access to a certain excimer laser (WaveLight
EX500, Alcon Laboratories) can activate the aiming beam and refer to
its position by shifting it to the first Purkinje image or to any
intermediate point on the chord between it and the center of the
pupil.
 With other excimer laser systems, the projection of the illumination
lights can be used as a guide once the inlay has been placed because
the lights are concentric to the first Purkinje image.

Acutarget(assesing centration )(postop)
 “The image quantifies the location of the inlay relative to the
first Purkinje image and pupil center and allows the surgeon
to compare the postoperative results to the preoperative target,.
 “The outcomes are best when the inlay is positioned about
within 300 μm of the target.”
 neither slit lamps nor topographers can be used to assess inlay
centration postoperatively.
 “A slit lamp cannot be used because its optics are not coaxial,
and topographers also cannot provide accurate quantitative
information aboutinlay location,”.

Acutarget(assesing centration )(postop)
 the AcuTarget HD will help you manage the patient’s care.
And, if optimal outcomes are not achieved, it will help you
identify and address the root cause. Specifially, this
instrument can aid you in:
 • Determiningif the patient is compliant with their eye drop
regimen
 • Confiming the desired inlay placement was achieved
 • Finding other potential reasons for less than desired optical
quality

Kamra Inlay result (Seyeddain)
 a mean improvement from J6 pre-op to J1 in binocular
uncorrected near acuity (UNVA) in 32 emmetropic presbyopic
subjects,
 with 96.9% reported UNVA of J3 or better in the implanted eyes.
 No significant change in uncorrected distance acuity (UDVA) was
found at 24 months;
 the implanted eye retained a mean UDVA of 20/20.10

Kamra Inlay result (Omer Yilmaz)
 Mean UNVA was J1 in 22 participants with 96% reading J3 or better;
 UDVA in all eyes was 20/40 or better.
 The small decrease in both UNVA and UDVA in five eyes was suspected
to be caused by age related cataract progression.
 Two patients elected to undergo cataract removal and both reported a
final UNVA of J1 or better with retainment of KAMRA inlays.
 Finally, four explantations were performed in this series due to issues
related to two microkeratome flaps and two post-operative refractive
shifts.
 All four subjects returned to within +/- 1D of their pre-operative refractive
status with no loss of corrected distance or near acuity

 on 407 patients with follow-up through month 6. In the non-
dominant eye,
 17.9% achieved 20/20 uncorrected near vision,
 67.3% were at 20/32, and 83% were 20/40;
 93.4% were 20/32 in distance vision, and
 97.1% achieved 20/40 or better distance vision.
 The Snellen distance vision improves over time but remains
"essentially unchanged.“
Kamra Inlay result (Kevin L. Waltz)

 Published data from a 24-month study of 32 implanted eyes (32 patients) in
Europe showed an improvement in all tested parameters of reading
performance.
 Using the Salzburg Reading Desk,
 A change in patients’ mean reading distance from the preoperative value of 48.1 ±5.5
cm to 38.9 ±6.3 cm
 Mean reading acuity with best distance correction improved from 0.3 ±0.14 logRAD
to 0.24
±0.11 logRAD
 mean reading speed increased from 142 ±13 to 149 ±17 words per minute (P = .029).
 There was a mean bilateral improvement in reading distance of 2.7 ±1.6 lines in the
other 30 patients.

Kamra Inlay result (Dexl et al)

Kamra Inlay (Grabner et al )
 on 32 patients who were presbyopic emmetropes aged between 45 and 55
years of age. All had a spherical equivalent within half a dioptre of
emmetropia, required a reading add between 1.0 D and 2.5 D
 mean gain of 4.6 lines of uncorrected near visual acuity from preoperative values in
the implanted eye, with patients reaching J1
 one of the FDA’s criterion for approval of the device as a treatment for presbyopia
was that 75 per cent must be J5 or better. In fact, 98 per cent of patients in the study
achieved J3 or better and half achieved J1, he pointed out.
 There was a mean gain of 1.6 lines in intermediate visual acuity (20/25) and
 Preoperative UCDVA was 20/20 or better in all eyes. However, at six months’ follow-
up it was 20/20 in two thirds of eyes, 20/25 or better in 88 per cent, and 20/32 or
better in all eyes.
 a mean loss of 1 line of distance visual acuity
 Bilateral uncorrected distance visual acuity remained unchanged at 20/16.

 In these studies, the inlay is placed under a 200-µm LASIK
flap after excimer laser ablation.
 Emerging procedures include the Kamra’s implantation
into pockets for presbyopic patients after previous LASIK
as well as its implantation in monofocal pseudophakic
patients.
 To date, the results of these combined procedures have
been promising and could greatly expand potential
candidacy for the Kamra
Kamra Inlay(SimLasik)

Kamra Inlay(US IDE Clinical Trial Results)
 In the US IDE study, 24 sites have enrolled 508 patients between 45 and 60 years of age.
 The results for the implanted eye were
 an UCNVAof between J2 and J 3 at 18 months
(n = 243), which remained stable through 24 months
(n = 85).
 IVA remained stable as well, with a mean intermediate measurement of 20/25 from
18 to 24 months.
 DVA remained stable throughout the study, with a mean uncorrected value of
20/20.
 BCDVA was better than 20/20 in the treated eye in all patients.
 Uncorrected binocular distance visual acuity improved at 24 months to 20/16.
 In mesopic conditions, a slight decrease in contrast sensitivitywas noted compared
with preoperative values, although this parameter remained within normal limits

Kamra Inlay(US IDE Clinical Trial Results)

Kamra Inlay ( effect on stereopsis)
 Prospective, 6 month study of 60 patients
using the Optec Functional visual analyzer
Stereo test.
 Inclusion criteria included
 age of 45 – 60 years with
 a spherical equivalent between+ 0.50 DS to -
0.75 DS and
 an uncorrected near visual acuity (VA) of worse
than 20/40, and better than 20/100 and a best
corrected distance VA > 20/20 in both
eyes.
 Inlays were implanted monocularly in the
non-dominant.
Uncorrected (U) near (N) and distance (D)
VA and stereopsis were measured
preoperatively and at 6 months
postoperatively.

Kamra Inlay (flap or pocket)
 Based on clinical trial results, there appears to be a higher
incidence of SPK (dry eye) after a flap procedure than a
pocket based procedure

Kamra inlay (Advantages of Pocket
Procedures)
 Significantly improved refractive stability and
predictability
 Minimal effect on corneal strength
 Simplified procedure
 Easy centration
 Improved healing and visual outcomes

sim-LASIK
 Outside the United States, the simultaneous treatment of ametropia and presbyopia using LASIK and a
Kamra inlay is gaining popularity.
 In this procedure, called sim-LASIK, the inlay is placed under a LASIK flap immediately following an
excimer laser ablation.
 The 1-year results for a series of 1,535 consecutive eyes (1,535 presbyopic patients) in Japan showed that
 the mean uncorrected near visual acuity at 30 cm improved by 4 lines from J9 preoperatively to J2.7
 The patients' mean uncorrected distance visual acuity improved 8 lines from 20/125 preoper-atively to 20/20.
 Ninety percent of the patients were satis-fied with their results.7
 The most recent and exciting application for the Kamra inlay is the correction of presbyopia in patients
who have undergone LASIK. The surgeon creates a pocket under the LASIK flap and inserts the corneal
inlay.
 A recent study found that a femtosecond laser-created corneal pocket can be created beneath a previous
LASIK flap and a small-aperture corneal inlay can be safely inserted to correct presbyopia.8
 Initial results show
 improvement in near vis-al acuity with a minimal reduction in distance visual acu-ity.
 At 3 months postoperatively, the mean uncorrected near visual acuity improved by 4 lines from J6 preopera-tively to J2
.8

 This year, Dr. Bond was most intrigued by research on the use of a
presbyopic corneal inlay in the eyes of patients who had undergone RK,
something he had before considered to be “inadvisable if not impossible.”
The investigators, Dr. Bond continued, “described 3-month results in two
patients who underwent Kamra inlay [AcuFocus, Inc.] implantation surgery
after previous RK. The article reported excellent results in this admittedly
small and early study (really a two-case report), with effective near vision
and no impact on the uncorrected distance visual acuity in both patients.
Care was taken in the first patient to not intersect the RK incisions with the
Ziemer [Ophthalmic Systems AG] femtosecond [laser-made] corneal
pockets, which were also created at 270º inferiorly, not temporally as usual.
The second [patient] had a residual refractive error, and a LASIK procedure
was performed on the same day, but immediately prior to, the inlay
implantation surgery. The inlay was implanted under the LASIK flap, also in
the inferior position.12 This is wild stuff.”

Kamra

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