Calhoun Vision Light Adjustable Lens (LAL) in Subjects With Pre-Existing Corneal Astigmatism
- Conditions
- Cataract
- Interventions
- Device: LAL (Light Adjustable Lens) and Light Deliver Device (LDD)Device: Monofocal control IOL
- Registration Number
- NCT01496066
- Lead Sponsor
- Calhoun Vision, Inc.
- Brief Summary
The purpose is to evaluate the Calhoun Vision Light Adjustable Lens (LAL) and Light Delivery Device (LDD) for reducing astigmatism and improving uncorrected vision after implantation.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 600
- Undergoing cataract surgery and be willing to have LAL or commercially available IOL implanted
- Pre-operative regular corneal astigmatism of >= 0.75 diopters and <= 2.0 diopters
- Best spectacle corrected visual acuity reduced to 20/40 or worse with or without glare
- Projected best spectacle corrected visual acuity of 20/20 or better
- Clear intraocular media other than cataract
- Potentially good vision in fellow eye
- Fully dilated pupil of >= 7.0 mm
- Zonular laxity or dehiscence
- Pseudoexfoliation
- Age related macular degeneration
- Retinal degenerative disorder
- Diabetes with any evidence of retinopathy
- Glaucomatous optic neuropathy, uveitis, significant anterior segment pathology, keratoconus
- Corneal dystrophy, previous corneal or intraocular surgery
- Complications during cataract surgery
- Serious co-morbid conditions
- Systemic medications that my increase UV sensitivity
- Irregular astigmatism
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description LAL LAL (Light Adjustable Lens) and Light Deliver Device (LDD) LAL implanted Monofocal control Monofocal control IOL Monofocal control IOL implanted
- Primary Outcome Measures
Name Time Method Rotation of LAL Landmark Meridian to Anatomical Landmark at Pre-Adjustment and 6 Months Postop 6 months Number (%) of eyes with rotation of LAL meridian of ≤ 5 degrees from Pre-Adjustment to 6 months postop. This endpoint was achieved by taking dilated anterior segment photographs of the LAL at Pre-Adjustment and 6 months postop. The angular difference between a landmark on the LAL and an anatomical landmark on the subjects eye was measured. The same landmarks on the LAL and the subjects eye were used at each time point. The angular difference between the two time points was then determined.
Percent Absolute Reduction in MRSE 6 months Percent absolute reduction in Manifest Refraction Spherical Equivalent (MRSE) from Pre-Adjustment (LAL) or 17-21 days post-op (control) to 6 months postop. It is used to describe an ophthalmic refraction with one number. It is defined as the (sphere)+ 0.5(cylinder). So, if you had a refraction of +1.00-1.00x090 the MRSE would be +0.50, the +1.00 is the sphere and the -1.00 is the cylinder in this example. If you had a refraction of +0.25-1.50x145 the MRSE would be -0.50. The absolute value of the MRSE is taken and its reduction is calculated from Pre-Adjustment (LAL) or 17-21 days post-op (control) to 6 months postop.
Percent Reduction in Manifest Cylinder 6 months Percent reduction in manifest cylinder from Pre-Adjustment (LAL) or 17-21 days post-op (control) to 6 months postop. Manifest cylinder refers to only the astigmatic or cylindrical component of an ophthalmic manifest refraction. For example if someone had a refraction of +0.50-1.00x090, the -1.00 is the manifest cylinder component. The reduction of the manifest cylinder is determined from Pre-Adjustment (LAL) or 17-21 days post-op (control) to 6 months postop.
- Secondary Outcome Measures
Name Time Method Uncorrected Visual Acuity 20/20 or Better 6 months Percent of eyes with UCVA of 20/20 or better in the LAL treatment group at 6 months postoperatively was calculated to determine if it is significantly greater than the percent of eyes with UCVA of 20/20 or better in the monofocal control group at 6 months postoperatively.
Mean Reduction in Cylinder by Cylinder Adjustment Stratum (0.75D-1.25D) 6 months Percent reduction in absolute manifest cylinder in the LAL treatment group was calculated to determine if it is significantly greater than the percent reduction in absolute cylinder in the monofocal control group at 6 months postoperatively compared to pre-adjustment in the LAL group/17-21 days postoperative in the control group. Results were to be evaluated for each cylinder adjustment stratum (0.75-1.25 D and 1.50-2.00 D) separately.
Mean Reduction in Cylinder by Cylinder Adjustment Stratum (>1.25D) 6 months Percent reduction in absolute manifest cylinder in the LAL treatment group was calculated to determine if it is significantly greater than the percent reduction in absolute cylinder in the monofocal control group at 6 months postoperatively compared to Pre-Adjustment in the LAL group/17-21 days postoperative in the control group.
Mean BSCVA 6 months Mean BSCVA for the "best case" cohort (no macular problems) at 6 months postoperatively was compared between the LAL treatment group and the monofocal control group. Endpoint success was to be achieved if the difference in mean BSCVA between the LAL cohort and the monofocal control group is within 1 line (0.1 LogMAR) (non-inferiority margin or delta).
Percent Absolute Reduction in Manifest Refraction Spherical Equivalent (MRSE) for Eyes With <0.75 D Cylinder Postoperatively 6 months For eyes with \<0.75 D of cylinder at pre-adjustment (LAL)/17-21 days (control group), percent mean absolute reduction in MRSE by subject in the LAL treatment group was calculated to determine if it is significantly greater than the percent reduction in mean absolute MRSE in the monofocal control group at 6 months postoperatively compared to pre-adjustment in the LAL group/17-21 days postoperative in the control group.
Trial Locations
- Locations (17)
Jules Stein Eye Institute
🇺🇸Los Angeles, California, United States
Arbor Centers for Eye Care
🇺🇸Orland Park, Illinois, United States
Newsom Eye
🇺🇸Sebring, Florida, United States
Minnesota Eye Consultants, PA
🇺🇸Bloomington, Minnesota, United States
Ophthalmology Consultants, Ltd.
🇺🇸Saint Louis, Missouri, United States
Carolina Vision Center
🇺🇸Fayetteville, North Carolina, United States
Eye Consultants of Texas
🇺🇸Grapevine, Texas, United States
Focal Point Vision
🇺🇸San Antonio, Texas, United States
Hoopes Vision
🇺🇸Draper, Utah, United States
Wolstan & Goldberg Eye Associates
🇺🇸Torrance, California, United States
Eye Surgeons of Indiana
🇺🇸Indianapolis, Indiana, United States
Jones Eye Clinic
🇺🇸Sioux City, Iowa, United States
Discover Vision & Laser Center
🇺🇸Leawood, Kansas, United States
Cleveland Eye Clinic
🇺🇸Brecksville, Ohio, United States
EyeSight Ophthalmic Services, PA
🇺🇸Somersworth, New Hampshire, United States
Vance Thompson Vision
🇺🇸Sioux Falls, South Dakota, United States
Vold Vision
🇺🇸Fayetteville, Arkansas, United States