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

Cataract Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01496066
• Other study ID #: CSP-002-03
• Status: Completed
• Phase: N/A
• Start date: December 2011
• Est. completion date: June 2016

Study information

• Verified date: May 2018
• Source: Calhoun Vision, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 600
• Est. completion date: June 2016
• Est. primary completion date: June 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Astigmatism
• Cataract

Intervention

Device:
• LAL (Light Adjustable Lens) and Light Deliver Device (LDD)
LAL implanted and adjusted with LDD
• Monofocal control IOL
Commercially available monofocal intraocular lens (IOL)

Locations

Country	Name	City	State
United States	Minnesota Eye Consultants, PA	Bloomington	Minnesota
United States	Cleveland Eye Clinic	Brecksville	Ohio
United States	Hoopes Vision	Draper	Utah
United States	Carolina Vision Center	Fayetteville	North Carolina
United States	Vold Vision	Fayetteville	Arkansas
United States	Eye Consultants of Texas	Grapevine	Texas
United States	Eye Surgeons of Indiana	Indianapolis	Indiana
United States	Discover Vision & Laser Center	Leawood	Kansas
United States	Jules Stein Eye Institute	Los Angeles	California
United States	Arbor Centers for Eye Care	Orland Park	Illinois
United States	Ophthalmology Consultants, Ltd.	Saint Louis	Missouri
United States	Focal Point Vision	San Antonio	Texas
United States	Newsom Eye	Sebring	Florida
United States	Jones Eye Clinic	Sioux City	Iowa
United States	Vance Thompson Vision	Sioux Falls	South Dakota
United States	EyeSight Ophthalmic Services, PA	Somersworth	New Hampshire
United States	Wolstan & Goldberg Eye Associates	Torrance	California

Sponsors (1)

Lead Sponsor	Collaborator
Calhoun Vision, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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