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ENROLLING BY INVITATION
NCT01757132
NA

Post-Approval Study of the Implantable Miniature Telescope

Sponsor: VisionCare, Inc.

View on ClinicalTrials.gov

Summary

The objective of the PAS-01 study is to assess the safety of the intraocular as measured by the cumulative incidence of patients who within 5 years after implantation experience persistent vision-impairing corneal edema (corneal edema leading to persistent loss of best corrected distance visual acuity \>2 lines from pre-surgery baseline level). The study will test the null hypothesis that the percentage of patients who experience persistent vision-impairing corneal edema is \>17% against the alternative that the percentage is \<17%. The null hypothesis will be rejected if the upper bound of the two-sided 95% confidence integral for the observed percentage is \<17%.

Official title: Post-approval Study of VisionCare's Implantable Miniature Telescope (by Dr. Isaac Lipshitz) in Patients With Bilateral Severe to Profound Central Vision Impairment Assoc. With End-stage Age-related Macular Degeneration

Key Details

Gender

All

Age Range

65 Years - Any

Study Type

INTERVENTIONAL

Enrollment

770

Start Date

2010-08

Completion Date

2028-12

Last Updated

2018-11-16

Healthy Volunteers

Yes

Conditions

Interventions

DEVICE

Implantable Miniature Telescope

Device - Implantable Miniature Telescope

Locations (16)

Arizona Eye Center

Chandler, Arizona, United States

Retinal Consultants of Arizona, LTD

Phoenix, Arizona, United States

Barnet, Dulaney, Perkins Eye

Phoenix, Arizona, United States

Retina-Vitreous Associates

Beverly Hills, California, United States

Retina Consultants of Orange County

Fullerton, California, United States

Loma Linda University Health Care

Loma Linda, California, United States

University of California - Davis

Sacramento, California, United States

Specialty Eye Care (Glaucoma Consultants of Colorado)

Parker, Colorado, United States

Retina Speciality Institute

Pensacola, Florida, United States

Sarasota Retinal Institute

Sarasota, Florida, United States

Emory Eye Center

Atlanta, Georgia, United States

University of Michigan, Kellogg Eye Center

Ann Arbor, Michigan, United States

Pepose Vision Institute

Chesterfield, Missouri, United States

New York Eye & Ear

New York, New York, United States

Fine, Hoffman & Packer

Eugene, Oregon, United States

Valley Retina Institute

McAllen, Texas, United States