Calhoun Vision Light Adjustable Lens (LAL) in Subjects With Pre-Existing Corneal Astigmatism

Study Overview
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Brief Summary
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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.

Official Title
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A Prospective Randomized Controlled Multi-Center Clinical Study to Evaluate the Safety and Effectiveness of the Light Adjustable Lens (LAL) in Subjects With Pre-Existing Corneal Astigmatism

Conditions
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Cataract

Intervention / Treatment
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* Device: LAL (Light Adjustable Lens) and Light Deliver Device (LDD)
* Device: Monofocal control IOL


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Phase 3 medical device study
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: LAL<br>LAL implanted | Device: LAL (Light Adjustable Lens) and Light Deliver Device (LDD)<br>* LAL implanted and adjusted with LDD<br>|
| Active Comparator: Monofocal control<br>Monofocal control IOL implanted | Device: Monofocal control IOL<br>* Commercially available monofocal intraocular lens (IOL)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percent Reduction in Manifest Cylinder | 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. | 6 months | 
| Percent Absolute Reduction in MRSE | 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. | 6 months | 
| Rotation of LAL Landmark Meridian to Anatomical Landmark at Pre-Adjustment and 6 Months Postop | 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. | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Uncorrected Visual Acuity 20/20 or Better | 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. | 6 months | 
| Mean Reduction in Cylinder by Cylinder Adjustment Stratum (0.75D-1.25D) | 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. | 6 months | 
| Mean Reduction in Cylinder by Cylinder Adjustment Stratum (>1.25D) | 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. | 6 months | 
| Percent Absolute Reduction in Manifest Refraction Spherical Equivalent (MRSE) for Eyes With <0.75 D Cylinder Postoperatively | 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. | 6 months | 
| Mean BSCVA | 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). | 6 months |