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Post-Approval Study of the Implantable Miniature Telescope
Sponsor: VisionCare, Inc.
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
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