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Clinical Trials in the USA / NCT01757132
Enrolling by invitation Not applicable

Post-Approval Study of the Implantable Miniature Telescope

NCT01757132 · tracked via the Priya Life Science USA tracker
Sponsor
VisionCare, Inc.
Phase
Not applicable
Started
2010-08
Last updated
2018-11-16

Condition(s) studied

AMD

Investigational drug(s) / intervention(s)

Implantable Miniature Telescope

Implantable Miniature Telescope: Device - Implantable Miniature Telescope

Study 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%.

Eligibility

Sex
ALL
Min age
65 Years
Max age
Healthy volunteers
Accepted
Inclusion Criteria: * 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. * 65 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 Exclusion Criteria: * 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 * inflammatory ocular disease * zonular weakness/instability of crystalline lens, or pseudoexfoliation * diabetic retinopathy * untreated retinal tears * retinal vascular disease * optic nerve disease * history of retinal detachment * intraocular tumor * retinitis pigmentosa

Primary outcome measure(s)

Trial sites (16)

FacilityCityRegionStatus
Arizona Eye Center Chandler Arizona
Retinal Consultants of Arizona, LTD Phoenix Arizona
Barnet, Dulaney, Perkins Eye Phoenix Arizona
Retina-Vitreous Associates Beverly Hills California
Retina Consultants of Orange County Fullerton California
Loma Linda University Health Care Loma Linda California
University of California - Davis Sacramento California
Specialty Eye Care (Glaucoma Consultants of Colorado) Parker Colorado
Retina Speciality Institute Pensacola Florida
Sarasota Retinal Institute Sarasota Florida
Emory Eye Center Atlanta Georgia
University of Michigan, Kellogg Eye Center Ann Arbor Michigan
Pepose Vision Institute Chesterfield Missouri
New York Eye & Ear New York New York
Fine, Hoffman & Packer Eugene Oregon
Valley Retina Institute McAllen Texas

More VisionCare, Inc. trials in the USA

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT01757132 on ClinicalTrials.gov ↗ ← All trials in the USA