Presentation on theme: "Light Adjustable Lens (LAL) Phase III FDA Clinical Study Caution –INVESTIGATIONAL DEVICE, LIMITED BY FEDERAL LAW TO INVESTIGATIONAL USE ONLY. Shamik Bafna,"— Presentation transcript:
Light Adjustable Lens (LAL) Phase III FDA Clinical Study Caution –INVESTIGATIONAL DEVICE, LIMITED BY FEDERAL LAW TO INVESTIGATIONAL USE ONLY. Shamik Bafna, MD William Wiley, MD Cleveland Eye Clinic
What is the Light Adjustable Lens (LAL ® )? 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 Initial research (1996-2000) performed as a joint collaboration between California Institute of Technology and UCSF School of Medicine –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
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. Limitations of Currently Available IOLs
Refractive Accuracy Studies Illustrate Need for an Adjustable IOL Source: 2013 Market Scope IOL Report 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
Light Adjustable Lens 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 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
LAL Procedure Conventional cataract surgery Subject has 1 st adjustment of the LAL 17-21 days after surgery. –Light Delivery Device irradiates the LAL with spatially profiled beam At 3-5 days following the 1 st adjustment, either a 2 nd adjustment or 1 st lock-in is performed based on the subject’s refraction. At 3-5 days following 1 st lock- in, the patient returns for a second and final lock-in.
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. –400 LAL eyes –200 control eyes
Phase III Study/Subject Information & Criteria 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 Study patients are required to wear UV- protective 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: –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) Source: Hengerer et al, Ophthalmology 2011; 118:2382-2388.
Accuracy of Spherical Equivalent Refraction (European Results of 121 Eyes, 18-months post lock-in) 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.
Patient astigmatism one week after lock-inPatient astigmatism pre-adjustment (17-21 days after implant) Pre-Adjustment Astigmatism Compared with 1 Week Post Lock-in CEC Clinical Results
≤ ≤ ≤≤ Correction of Astigmatism: Pre-Adjustment vs 1 week Post Lock-In CEC Clinical Results
≤ ≤ ≤ 100 % Reduction of MRSE Pre-Adjustment vs 1 Week Post Lock-In 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 CEC Clinical Results
The Calhoun Vision Light Adjustable Lens Designed to predictably achieve excellent distance acuity and customized to each patient’s unique eye measurements.