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

Not Applicable

Completed

• Conditions: Cataracts
• Interventions: Device: Lens implantation 0.00 D postop target; Device: Lens implantation +1.00 D postop target; Device: Lens implantation -1.00 D postop target

• Registration Number: NCT00845520
• Lead Sponsor: Calhoun Vision, Inc.

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-01
• Study First Submitted: 2009-02-13
• Study First Submitted QC: 2009-02-13
• Study First Posted: 2009-02-18
• Primary Completion: 2013-03
• Study Completion: 2013-03
• Results First Submitted: 2017-12-28
• Status Verified: 2018-06
• Results First Submitted QC: 2018-06-06
• Last Update Submitted: 2018-06-06
• Results First Posted: 2018-07-06
• Last Update Posted: 2018-07-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 74

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Lens implantation 0.00 D postop target	Lens implantation 0.00 D postop target	Lens implant power calculated for postoperative MRSE target of 0.00 D
Lens implantation +1.00 diopter (D) postop target	Lens implantation +1.00 D postop target	Lens implant power calculated for postoperative MRSE target of +1.00 D
Lens implantation -1.00 D postop target	Lens implantation -1.00 D postop target	Lens implant power calculated for postoperative MRSE target of -1.00 D

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Percentage of Participants With Eyes With Improvement in Uncorrected Visual Acuity (UCVA)	6 months post operative	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.

Trial Locations

Locations (6)

CODET Vision Institute; 🇲🇽 Tijuana, Zona Rio, Mexico

Maloney Vision Institute; 🇺🇸 Los Angeles, California, United States

Discover Vision Centers; 🇺🇸 Leawood, Kansas, United States

Price Vision Group; 🇺🇸 Indianapolis, Indiana, United States

Altos Eye Physicians; 🇺🇸 Los Altos, California, United States

Pepose Vision Institute; 🇺🇸 Chesterfield, Missouri, United States