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

NCT00845520 | Completed Results

• 1 other identifier: CSP 002-00
• Study Type: interventional
• Target: 74
• Locations: 2 countries
• Sites: 6

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.

Conditions

Cataracts

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Percentage of Participants With Eyes With Improvement in Uncorrected Visual Acuity (UCVA)

  6 months post operative

Other Outcomes (1)

• Percentage of Eyes With Best Corrected Visual Acuity (BSCVA) of 20/40 or Better

  12 months

Study Arms (3)

Lens implantation +1.00 diopter (D) postop target

EXPERIMENTAL

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 postop target

EXPERIMENTAL

Lens implant power calculated for postoperative MRSE target of -1.00 D

Device: Lens implantation -1.00 D postop target

Lens implantation 0.00 D postop target

EXPERIMENTAL

Lens implant power calculated for postoperative MRSE target of 0.00 D

Device: Lens implantation 0.00 D postop target

Interventions

Lens implantation -1.00 D postop target DEVICE

Lens implantation -1.00 D postoperative MRSE target. Light Delivery Device treatment based on postoperative manifest refraction.

Also known as: Light Delivery Device

Lens implantation -1.00 D postop target

Lens implantation 0.00 D postop target DEVICE

Lens implantation 0.00 D postoperative MRSE target. Light Delivery Device treatment based on postoperative manifest refraction.

Also known as: Light Delivery Device

Lens implantation 0.00 D postop target

Eligibility Criteria

• Age: 40 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Calhoun Vision, Inc.: lead

Study Sites (6)

Altos Eye Physicians

Los Altos, California, 94024, United States

Location

Maloney Vision Institute

Los Angeles, California, 90024, United States

Location

Price Vision Group

Indianapolis, Indiana, 46260, United States

Location

Discover Vision Centers

Leawood, Kansas, 66211, United States

Location

Pepose Vision Institute

Chesterfield, Missouri, 63017, United States

Location

CODET Vision Institute

Tijuana, Zona Rio, 22320, Mexico

Location

MeSH Terms

Conditions

Cataract

Condition Hierarchy (Ancestors)

Lens Diseases; Eye Diseases

Results Point of Contact

• Title: Maureen O'Connell Vice President, Regulator and Clinical Affairs
• Organization: RxSight, Inc.

moconnell@rxsight.com

978-207-12415

Study Officials

• R. Doyle Stulting, MD, PhD

  Emory Eye Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Phase 2 medical device study

Study Record Dates

• First Submitted: February 13, 2009
• First Posted: February 18, 2009
• Study Start: January 1, 2009
• Primary Completion: March 1, 2013
• Study Completion: March 1, 2013
• Last Updated: July 6, 2018
• Results First Posted: July 6, 2018

Record last verified: 2018-06

Data Sharing

• IPD Sharing: Will not share

Locations

ME (1); US (5)