NCT01757132
Post-Approval Study of the Implantable Miniature Telescope
Enrolling by Invitation
NAAges 65+InterventionalVisionCare, Inc.
~770 participants
Updated 2018-11-16 on ClinicalTrials.gov
What's tested:Implantable Miniature Telescope
At a glance
Recruiting sites
0 of 16 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Long term safety study of implantable miniature telescope
Measured over 5 years after implantation
Conditions
Where it's being run
16 sites across 10 statesCalifornia4
Arizona3
Florida2
Colorado1
Georgia1
Michigan1
Missouri1
New York1
Study leadership
- Oliver D Schein, MD · PRINCIPAL_INVESTIGATOR · Johns Hopkins University
Who to contact
This trial hasn't published a contact. View it on ClinicalTrials.gov
Do you actually qualify for this trial?
Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.
Eligibility criteria
Inclusion
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
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
What this trial measures
- Long term safety study of implantable miniature telescope5 years after implantation
Number of persistent vision impairing corneal edema adverse events