Post-Approval Study of the Implantable Miniature Telescope

Enrolling by invitation · Not applicable

Conditions studied: AMD

In brief

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%.

Key facts

Study ID

NCT01757132

Run by

VisionCare, Inc.

People needed

770

Starts

2010-08-01

Expected to finish

2028-12-01

Last updated by the study team

2018-11-16

Who can join

Age: 65 and older. Sex: any. Healthy volunteers: accepted.

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.
• 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

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
• 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

Where it is running

• 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

Full record on ClinicalTrials.gov

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