Phase
Condition
Myopic Macular Degeneration
Aging
Macular Degeneration
Treatment
N/AClinical Study ID
Ages > 65 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Have retinal findings of geographic atrophy or disciform scar with foveal involvementas determined by FA
Be age 65 or older
Have BCDVA between 20/160 to 20/800 (inclusive) on ETDRS chart
Be pseudophakic in the eye selected for telescope implantation
Agree to undergo pre-surgery training with a low vision specialist
Achieve at least a 5-letter improvement on the ETDRS chart with an external telescope
Agree to participate in postoperative vision training with a low vision specialist.
Patients must be able to provide and sign a voluntary informed consent.
Patients must not meet any of the exclusion criteria below.
Exclusion
Exclusion Criteria:
Stargardt's macular dystrophy
Cognitive impairment that would interfere with the ability to understand instructions,follow directions, or prevent proper visual training/rehabilitation with the device.
Any ophthalmic pathology that compromises fellow-eye peripheral vision
A history of steroid-responsive rise in intraocular pressure (IOP), uncontrolledglaucoma, or preoperative IOP >22mmHg while on maximum medication
Known sensitivity to planned study concomitant medications.
An ocular condition that predisposes the patient to eye rubbing.
Patients participating in any other ophthalmic drug or device clinical trial duringthe time of this clinical investigation.
Operative eye with:
Evidence of active CNV or treatment of CNV within 6 months
IOLs of the following types: PMMA, Crystalens, Tetraflex, Synchrony.
Central anterior chamber depth (ACD) < 3.0 mm; measurement of the ACD should betaken from the posterior surface of the cornea (endothelium) to the anteriorsurface of the IOL.
Axial length < 21 mm or >27 mm
Endothelial cell density (ECD) lower than 2300 cells/mm2 for subjects between theages 65-69, lower than 2000 cells/mm2 for subjects between the ages of 70-74, andlower than 1800 cells/mm2 for subjects 75 years old or greater.
Corneal stromal or endothelial dystrophies, including guttata
History of intraocular or corneal surgery (including DSEK) except cataractremoval and IOL placement
History of complicated cataract surgery
Compromised capsular bag (previous YAG posterior capsulotomy, evidence oftearing)
History of Radial Keratotomy
Inflammatory ocular disease
Pseudoexfoliation or zonular weakness
Diabetic retinopathy
Untreated retinal tears
Retinal vascular disease
Optic nerve disease
A history of retinal detachment
Intraocular tumor
Retinitis pigmentosa
Prior or expected ophthalmic related surgery within 30 days preceding telescopeimplantation
Any medical or ophthalmic condition that in the opinion of the investigatorrenders the subject unsuitable for participation in the study
Study Design
Connect with a study center
Retinal Consultants of AZ
Phoenix, Arizona 85014
United StatesActive - Recruiting
UC Irvine, Gavin Herbert Eye Institute
Irvine, California 92697
United StatesActive - Recruiting
Loma Linda University Medical Center
Loma Linda, California 92354
United StatesActive - Recruiting
Eye Physicians of Long Beach
Long Beach, California 90808
United StatesActive - Recruiting
Eye Care of San Diego
San Diego, California 92103
United StatesActive - Recruiting
Orange County Retina
Santa Ana, California 92705
United StatesActive - Recruiting
Sarasota Retina Institute
Sarasota, Florida 34239
United StatesActive - Recruiting
University of Michigan, Kellogg Eye Center
Ann Arbor, Michigan 48105
United StatesActive - Recruiting
Minnesota Eye Consultants
Minnetonka, Minnesota 55305
United StatesActive - Recruiting
Associated Eye Care
Stillwater, Minnesota 55082
United StatesActive - Recruiting
St. John's Clinic - Eye Specialists. Mercy
Springfield, Missouri 65804
United StatesActive - Recruiting
Eye Associates of New Mexico Vision Research Center
Albuquerque, New Mexico 87109
United StatesActive - Recruiting
Eye Specialty Group
Memphis, Tennessee 38120
United StatesActive - Recruiting
Cornea Consultants of Texas
Fort Worth, Texas 76107
United StatesActive - Recruiting
Not the study for you?
Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.