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

Calhoun Vision, Inc.600 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

600

Conditions

Cataract

Interventions

LAL (Light Adjustable Lens) and Light Deliver Device (LDD)DEVICE

LAL implanted and adjusted with LDD

Monofocal control IOLDEVICE

Commercially available monofocal intraocular lens (IOL)

Eligibility

Sex: ALLMin age: 40 YearsMax age: 80 Years

Medical Language ↔ Plain English

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

Locations (17)

Vold Vision

Fayetteville, Arkansas, United States

Jules Stein Eye Institute

Los Angeles, California, United States

Outcomes

Primary Outcomes

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.

Time frame: 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.

Time frame: 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.

Time frame: 6 months

Secondary Outcomes

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.

Data from ClinicalTrials.gov

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