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)
Long term safety study of implantable miniature telescope — 5 years after implantation Number of persistent vision impairing corneal edema adverse events
Trial sites (16)
Facility
City
Region
Status
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)
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.
We use cookies to analyse site traffic and improve your experience. With your consent, we may also use cookies for advertising. You can change your choice at any time.