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

Calhoun Vision, Inc.6 sites in 2 countries74 target enrollmentJanuary 2009

ConditionsCataracts

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Cataracts
Sponsor: Calhoun Vision, Inc.
Enrollment: 74
Locations: 6
Primary Endpoint: Percentage of Eyes Achieving a Manifest Refraction Spherical Equivalent (MRSE) Within ± 0.50 D of the Intended Adjustment Target
Status: Completed
Last Updated: 7 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

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.

Registry

clinicaltrials.gov

Start Date

January 2009

End Date

March 2013

Last Updated

7 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Calhoun Vision, Inc.

Responsible Party

Sponsor

Eligibility Criteria

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.

Outcomes

Primary Outcomes

Percentage of Eyes Achieving a Manifest Refraction Spherical Equivalent (MRSE) Within ± 0.50 D of the Intended Adjustment Target

Time Frame: 6 months post-operative

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.