Post-Approval Study of the Implantable Miniature Telescope
PAS-01
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
1 other identifier
interventional
770
1 country
16
Brief 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%.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Aug 2010
Longer than P75 for not_applicable
16 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2010
CompletedFirst Submitted
Initial submission to the registry
November 13, 2012
CompletedFirst Posted
Study publicly available on registry
December 28, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2028
ExpectedNovember 16, 2018
November 1, 2018
13.3 years
November 13, 2012
November 15, 2018
Conditions
Outcome Measures
Primary Outcomes (1)
Long term safety study of implantable miniature telescope
Number of persistent vision impairing corneal edema adverse events
5 years after implantation
Study Arms (1)
Implantable Miniature Telescope
OTHERPost approval study
Interventions
Device - Implantable Miniature Telescope
Eligibility Criteria
You may qualify if:
- stable severe (BVDCA of 10/160 or poorer) to profound (BCDVA of 20/800 or better) vision impairment caused by bilateral central scotomas associated with end-stage age-related macular degeneration.
- years of age or older
- retinal findings of geographic atrophy or disciform scar with foveal involvement
- visually significant cataract
- agree to undergo pre- and post-surgery training and assessment
- achieve at least a 5-letter improvement with external telescope
- have adequate peripheral vision in the eye not scheduled for surgery
You may not qualify if:
- Stargardt's macular dystrophy
- Anterior chamber depth \< 3.0mm
- Presence of corneal guttate
- Do not meet minimum age and endothelial cell density requirements
- evidence of CNV or treatment of CNV within the past 6 months
- cognitive impairment that would interfere with ability to understand and complete Acceptance of Risk and Informed Decision Agreement or prevent proper training/rehabilitation
- previous intraocular or cornea surgery of any kind in operative eye, including any type of surgery for either refractive or therapeutic purposes or who have prior or expected ophthalmic related surgery within 30 days preceding intraocular telescope surgery
- history of steroid-responsive rise in intraocular pressure, uncontrolled glaucoma, or preoperative IOP \>22 mm Hg while on maximum medication
- known sensitivity to post-operative medications
- history of eye rubbing or an ocular condition that predisposes eye rubbing
- myopia \>6.0 D
- hyperopia \>4.0D
- axial length \<21mm
- narrow angle, i.e., \<Schaffer grade 2
- cornea stromal or endothelian dystrophies, including guttate
- +9 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- VisionCare, Inc.lead
Study Sites (16)
Arizona Eye Center
Chandler, Arizona, 85225, United States
Retinal Consultants of Arizona, LTD
Phoenix, Arizona, 85014, United States
Barnet, Dulaney, Perkins Eye
Phoenix, Arizona, 85016, United States
Retina-Vitreous Associates
Beverly Hills, California, 90211, United States
Retina Consultants of Orange County
Fullerton, California, 92835, United States
Loma Linda University Health Care
Loma Linda, California, 92350, United States
University of California - Davis
Sacramento, California, 95817, United States
Specialty Eye Care (Glaucoma Consultants of Colorado)
Parker, Colorado, 80134, United States
Retina Speciality Institute
Pensacola, Florida, 32503, United States
Sarasota Retinal Institute
Sarasota, Florida, 34239, United States
Emory Eye Center
Atlanta, Georgia, 30322, United States
University of Michigan, Kellogg Eye Center
Ann Arbor, Michigan, 48105, United States
Pepose Vision Institute
Chesterfield, Missouri, 63017, United States
New York Eye & Ear
New York, New York, 10003, United States
Fine, Hoffman & Packer
Eugene, Oregon, 97401, United States
Valley Retina Institute
McAllen, Texas, 78503, United States
Study Officials
- PRINCIPAL INVESTIGATOR
Oliver D Schein, MD
Johns Hopkins University
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- OTHER
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 13, 2012
First Posted
December 28, 2012
Study Start
August 1, 2010
Primary Completion
December 1, 2023
Study Completion (Estimated)
December 1, 2028
Last Updated
November 16, 2018
Record last verified: 2018-11