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

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

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 Overview

• Status: Completed
• Conditions: Cataract
• Intervention / Treatment: Device: LAL (Light Adjustable Lens) and Light Deliver Device (LDD); Device: Monofocal control IOL

• Study Type: Interventional
• Enrollment (Actual): 600
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Arkansas
    • Fayetteville, Arkansas, United States, 72704
      • Vold Vision
  • California
    • Los Angeles, California, United States, 90095
      • Jules Stein Eye Institute
    • Torrance, California, United States, 90505
      • Wolstan & Goldberg Eye Associates
  • Florida
    • Sebring, Florida, United States, 33870
      • Newsom Eye
  • Illinois
    • Orland Park, Illinois, United States, 60467
      • Arbor Centers for Eye Care
  • Indiana
    • Indianapolis, Indiana, United States, 46256
      • Eye Surgeons of Indiana
  • Iowa
    • Sioux City, Iowa, United States, 51104
      • Jones Eye Clinic
  • Kansas
    • Leawood, Kansas, United States, 66211
      • Discover Vision & Laser Center
  • Minnesota
    • Bloomington, Minnesota, United States, 55431
      • Minnesota Eye Consultants, PA
  • Missouri
    • Saint Louis, Missouri, United States, 63131
      • Ophthalmology Consultants, Ltd.
  • New Hampshire
    • Somersworth, New Hampshire, United States, 03878
      • Eyesight Ophthalmic Services, PA
  • North Carolina
    • Fayetteville, North Carolina, United States, 28304
      • Carolina Vision Center
  • Ohio
    • Brecksville, Ohio, United States, 44141
      • Cleveland Eye Clinic
  • South Dakota
    • Sioux Falls, South Dakota, United States, 57105
      • Vance Thompson Vision
  • Texas
    • Grapevine, Texas, United States, 76051
      • Eye Consultants of Texas
    • San Antonio, Texas, United States, 78229
      • Focal Point Vision
  • Utah
    • Draper, Utah, United States, 84020
      • Hoopes Vision

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Calhoun Vision, Inc.

Study record dates

Study Major Dates

• Study Start: December 1, 2011
• Primary Completion (Actual): June 1, 2016
• Study Completion (Actual): June 1, 2016

Study Registration Dates

• First Submitted: December 15, 2011
• First Submitted That Met QC Criteria: December 20, 2011
• First Posted (Estimate): December 21, 2011

Study Record Updates

• Last Update Posted (Actual): June 29, 2018
• Last Update Submitted That Met QC Criteria: May 30, 2018
• Last Verified: May 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Lens Diseases; Refractive Errors; Cataract; Astigmatism
• Other Study ID Numbers: CSP-002-03

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO