Transcript Light Adjustable Lens - Clear Choice Laser Eye Centers

Light Adjustable Lens (LAL)
Phase III FDA Clinical Study
Shamik Bafna, MD
William Wiley, MD
Cleveland Eye Clinic
Caution –INVESTIGATIONAL DEVICE, LIMITED BY FEDERAL
LAW TO INVESTIGATIONAL USE ONLY.
What is the Light Adjustable Lens (LAL®)?
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It was developed by Dan Schwartz, MD,
(Professor of Ophthalmology, University of
California San Francisco), and Robert
Grubbs, Ph.D. (Professor of Chemistry at
Caltech and a Nobel Laureate in Chemistry,
2005)
The LAL is the first lens designed to be
adjusted after the lens has been implanted
and the eye has healed.
This can be achieved by treating the lens
with UV light.
Calhoun History
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Initial research (1996-2000) performed as a joint
collaboration between California Institute of Technology
and UCSF School of Medicine
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Dan Schwartz, MD (UCSF)
Robert Grubbs, PhD (Cal Tech)
Julie Kornfield, PhD (Cal Tech)
Christian Sandstedt, PhD (Cal Tech)
Jagdish Jethmalani, PhD (Cal Tech)
Calhoun Vision Co-Founder,
Dr. Robert Grubbs, wins 2005 Nobel
Prize in Chemistry
The Light Adjustable
®
Lens (LAL )?
The LAL has the potential to change the global
landscape of cataract surgery as the only lens
in the world whose power can be adjusted after
implantation in a patient’s eye
 Designed for a customized and predictable
correction of residual refractive error after lens
implantation for optimal distance vision
– Spherical and cylindrical errors up to 2D
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Limitations of Currently Available IOLs
Unpredictable wound healing, errors in biometry, and
posterior capsular shrinkage can offset IOL power
calculation and lead to postoperative refractive errors.
 The result is the need for glasses, contact lenses, or
additional surgery to treat the refractive error in a
substantial number of patients.
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Refractive Accuracy Studies Illustrate
Need for an Adjustable IOL
 5 – 30% of patients
require secondary
enhancement
procedure to improve
visual outcomes.
 European Results:
Light Adjustable Lens
(Hengerer et al,
Ophthalmology
2011): 97% ± 0.25 D
98% ± 0.50 D
100% ± 1.00 D
Source: 2013 Market Scope IOL Report
Light Adjustable Lens
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3-piece IOL design
Blue PMMA modified-C haptics
Photosensitive silicone
6.0mm biconvex optic; Overall length 13.0mm
Diopter Power: +10.0 to +15.0 D and +25.0 to +30.0 D in 1.0
D increments; +16.0 to +24.0 D in 0.5 D increments
Posterior layer of 100 um or less with higher concentration of
UV absorber
Optic edge: Square on posterior surface; Round on anterior
surface
Light Delivery Device
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Standard slit-lamp
footprint
Flexibility for lens
modification
The heart is the digital
mirror device (DMD),
which allows generation
of customized spatial
irradiance profiles
~14 µm
Light Delivery Device
LAL Procedure
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Conventional cataract surgery
Subject has 1st adjustment of the LAL 17-21 days after
surgery.
– Light Delivery Device irradiates
the LAL with spatially profiled beam
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At 3-5 days following the 1st
adjustment, either a 2nd
adjustment or 1st lock-in is
performed based on the
subject’s refraction.
At 3-5 days following 1st lockin, the patient returns for a
second and final lock-in.
Mechanism of Action
Adding Power to the LAL
Adjustment Profiles
Negative Adjustment Profile
Normalized Irradiance
1.2
1
0.8
0.6
0.4
0.2
0
-4
-3
-2
-1
0
1
2
3
4
2
3
4
3
4
Distance (mm)
Positive Adjustment Profile
Normalized Irradiance
1.2
1
0.8
0.6
0.4
0.2
0
-4
-3
-2
-1
0
1
Distance (mm)
Astigmatic Adjustment Profile
Normlalized Irradiance
1.2
1
0.8
0.6
0.4
0.2
0
-4
-3
-2
-1
0
Distance (mm)
1
2
LAL Phase III Clinical Study
A Prospective Randomized Controlled Clinical
Study To Evaluate the Safety and Effectiveness
of the LAL in subjects with Pre-Existing
Corneal Astigmatism.
 The LAL Phase III clinical study involves the
treatment of 600 eyes monocularly.
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– 400 LAL eyes
– 200 control eyes
Phase III Study/Subject
Information & Criteria
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Study designed to show sphero-cylindrical correction with
the LAL
Subjects receive up to $600 for full participation in the study
Requires subject follow-ups for one year
Only one eye per subject can be enrolled
Subjects are randomized to either an LAL or standard
monofocal IOL in ratio of 2 out of 3 subjects receiving the
LAL
Subject cannot have had previous LASIK surgery
Subject must have corneal cyl of 0.75 – 2.00 D
UV Blocking Eyewear
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Study patients are required to wear UVprotective glasses at all times (indoors and
outdoors), except for showering and
sleeping, until the light treatments are
completed
Study Criteria
Have a visually significant cataract.
 Be between the ages of 40 to 80.
 Have some pre-existing corneal
astigmatism.
 Have not had previous corneal refractive
surgery such as RK, PRK, or LASIK.
 Have no ocular problems as determined by
the surgeon.
 Not be using UV-light sensitive drugs:
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– HCTZ, tetracycline, doxycycline, psoralens, amiodarone, phenothiazines,
chloroquine, hypericin, ketoprofen, piroxicam, lomefloxacin, and
methoxsalen
European Clinical Results
 Ruhr
University Eye Hospital,
Bochum, Germany
 Professor Burkhard Dick, MD
 Professor Fritz Hengerer, MD
 Ina Conrad-Hengerer, MD
Post-adjustment UCVA Compared to Pre-adjustment UCVA
(European results of 121 Eyes, 18-months post lock-in)
± 0.25 D: 97%
± 0.50 D: 98%
± 1.00 D: 100%
Source: Hengerer et al, Ophthalmology 2011;
118:2382-2388.
Accuracy of Spherical Equivalent Refraction
(European Results of 121 Eyes, 18-months post lock-in)
± 0.25 D: 97%
± 0.50 D: 98%
± 1.00 D: 100%
Source: Hengerer et al, Ophthalmology 2011;
118:2382-2388.
Stability of Visual Outcome:
Unchanged after 18 months
(European Results of 121 Eyes, 18-months post lock-in)
Source: Hengerer et al, Ophthalmology 2011;
118:2382-2388.
CEC Clinical Results
Pre-Adjustment Astigmatism Compared with 1
Week Post Lock-in
Patient astigmatism pre-adjustment
(17-21 days after implant)
Patient astigmatism one week after lock-in
CEC Clinical Results
Correction of Astigmatism:
Pre-Adjustment vs 1 week Post Lock-In
≤
≤
≤
≤
CEC Clinical Results
Reduction of MRSE
Pre-Adjustment vs 1 Week Post Lock-In
100
%
≤
≤
≤
CEC Clinical Results
BSCVA vs UCVA
Pre-Adjustment vs 1 Week Post Lock-In
CEC Clinical Results
UCVA
Pre-Adjustment vs 1 Week Post Lock-In
The Calhoun Vision Light
Adjustable Lens
Designed
to predictably achieve
excellent distance acuity and
customized to each patient’s unique
eye measurements.
Thank you