Safety and Effectiveness of the Calhoun Vision Light Adjustable Intraocular Lens (LAL)

A Prospective Multi-center Clinical Study to Evaluate the Safety and Effectiveness of the Light Adjustable Lens (LAL) in Subjects Undergoing Cataract Extraction

The primary objective of this study is to evaluate, for the visual correction of aphakia, the safety and effectiveness of the Calhoun Vision Light Adjustable intraocular lens (LAL) and Light Delivery Device (LDD) in treating postoperative residual refractive error by providing a stable, targeted refractive adjustment of the LAL power and lock-in treatments with the LDD.

Study Overview

• Status: Completed
• Conditions: Cataracts
• Intervention / Treatment: Device: Lens implantation +1.00 D postop target; Device: Lens implantation -1.00 D postop target; Device: Lens implantation 0.00 D postop target

• Study Type: Interventional
• Enrollment (Actual): 74
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Mexico
  • Zona Rio
    • Tijuana, Zona Rio, Mexico, 22320
      • CODET Vision Institute
• United States
  • California
    • Los Altos, California, United States, 94024
      • Altos Eye Physicians
    • Los Angeles, California, United States, 90024
      • Maloney Vision Institute
  • Indiana
    • Indianapolis, Indiana, United States, 46260
      • Price Vision Group
  • Kansas
    • Leawood, Kansas, United States, 66211
      • Discover Vision Centers
  • Missouri
    • Chesterfield, Missouri, United States, 63017
      • Pepose Vision Institute

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:

• Pre-operative regular corneal astigmatism less than or equal to 1.00 diopters by keratometry.
• Adults between the ages of 40 and 80 inclusive.
• Cataract causing reduction in best spectacle-corrected visual acuity to a level of 20/32 or worse.
• Best corrected visual acuity projected (by clinical estimate based upon past ocular history and retinal exam) to be 20/25 or better after cataract removal and IOL implantation.
• Clear intraocular media other than cataract.
• Potentially good vision in the fellow eye with BCVA 20/40 or better.
• Willing and able to comply with the schedule for power adjustment/lock-in treatments and the schedule for follow-up visits.
• Fully dilated pupil diameter of more than or equal to 7.0 mm.

Exclusion Criteria:

• Zonular laxity or dehiscence.
• Pseudoexfoliation.
• Age related macular degeneration involving the presence of geographic atrophy or soft drusen.
• Retinal degenerative disorder that is expected to cause future vision loss.
• Diabetes with any evidence of retinopathy.
• Evidence of glaucomatous optic neuropathy.
• History of uveitis.
• Significant anterior segment pathology, such as rubeosis iridis, aniridia, or iris coloboma.
• Corneal pathology that is either progressive or sufficient to reduce BCVA to 20/25 or worse.
• Keratoconus or suspected of having keratoconus.
• Corneal dystrophy including basement membrane dystrophy.
• Previous corneal or intraocular surgery
• Systemic medication that may increase sensitivity to UV light such as tetracycline, doxycycline, psoralens, amiodarone, and phenothiazines.
• Complications during cataract surgery including posterior capsule rupture, zonular rupture, radial capsulorhexis tear, vitreous loss, iris trauma, corneal complications or any intraoperative abnormality that may affect the postoperative pupillary dilation, or the centration or tilt of the intraocular lens.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Lens implantation +1.00 diopter (D) postop target; Lens implant power calculated for postoperative MRSE target of +1.00 D	Device: Lens implantation +1.00 D postop target; Lens implantation +1.00 D postoperative MRSE target. Light Delivery Device treatment based on postoperative manifest refraction.; Other Names: Light Delivery Device
Experimental: Lens implantation -1.00 D postop target; Lens implant power calculated for postoperative MRSE target of -1.00 D	Device: Lens implantation -1.00 D postop target; Lens implantation -1.00 D postoperative MRSE target. Light Delivery Device treatment based on postoperative manifest refraction.; Other Names: Light Delivery Device
Experimental: Lens implantation 0.00 D postop target; Lens implant power calculated for postoperative MRSE target of 0.00 D	Device: Lens implantation 0.00 D postop target; Lens implantation 0.00 D postoperative MRSE target. Light Delivery Device treatment based on postoperative manifest refraction.; Other Names: Light Delivery Device

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Eyes Achieving a Manifest Refraction Spherical Equivalent (MRSE) Within ± 0.50 D of the Intended Adjustment Target	Predictability of post-operative refractive adjustments of the implanted LAL, with 75% of the eyes achieving a manifest refraction spherical equivalent (MRSE) within ± 0.50 D of the intended adjustment target at the point of stability. All three arms of the study had the same end point so the results were presented as one combined cohort.	6 months post-operative

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Participants With Eyes With Improvement in Uncorrected Visual Acuity (UCVA)	Improvement in uncorrected visual acuity (UCVA): For those best case eyes with a pre-light treatment UCVA of 20/50 or worse, 65% of eyes should have an uncorrected visual acuity of 20/40 or better at the refractive stable point after the adjustment and lock-in treatments. All three arms of the study had the same end point so the results were presented as one combined cohort.	6 months post operative

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Eyes With Best Corrected Visual Acuity (BSCVA) of 20/40 or Better	Best Corrected Visual Acuity (BSCVA): The percentage of eyes achieving overall and best case BSCVA of 20/40 or better should be comparable to the FDA grid of historical controls for intraocular lenses. All three arms of the study had the same end point so the results were presented as one combined cohort.	12 months

Collaborators and Investigators

• Sponsor: Calhoun Vision, Inc.
• Investigators: Principal Investigator: R. Doyle Stulting, MD, PhD, Emory Eye Center

Study record dates

Study Major Dates

• Study Start: January 1, 2009
• Primary Completion (Actual): March 1, 2013
• Study Completion (Actual): March 1, 2013

Study Registration Dates

• First Submitted: February 13, 2009
• First Submitted That Met QC Criteria: February 13, 2009
• First Posted (Estimate): February 18, 2009

Study Record Updates

• Last Update Posted (Actual): July 6, 2018
• Last Update Submitted That Met QC Criteria: June 6, 2018
• Last Verified: June 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Lens Diseases; Cataract
• Other Study ID Numbers: CSP 002-00

Plan for Individual participant data (IPD)

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