Study of WA-NG Telescope Prosthesis in Patients With End-stage Age-related Macular Degeneration
NCT01361256 · Status: WITHDRAWN · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL
Last updated 2020-07-10
Summary
This is a pilot study to evaluate the safety of the Model WA-NG telescope prosthesis in patients with bilateral moderate to profound central vision impairment due to end-stage age-related macular degeneration.
Conditions
- Age Related Macular Degeneration
Interventions
- DEVICE
-
Telescope prosthesis
Monocular implantation of the telescope prosthesis after cataract extraction
- DEVICE
-
WA-NG Telescope Prothesis
The WA-NG telescope prosthesis (Figure 1) is the next generation telescopic implantable device which, when combined with the optics of the cornea, constitutes a telephoto system for improvement of visual acuity in patients with severe to profound vision impairment due to bilateral, end-stage age-related macular degeneration. The device is implanted in one of the patient's eyes. In this way, the implanted eye provides central vision and the non-implanted eye can continue to provide peripheral vision.
Sponsors & Collaborators
-
VisionCare, Inc.
lead INDUSTRY
Principal Investigators
-
Mordecai Rosner, MD · Sheba Medical Center
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 65 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2011-05-31
- Primary Completion
- 2015-04-30
- Completion
- 2016-05-31
Countries
- Israel
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