USA (Pittsburgh) feasibility study
Introduction
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Title of the study |
PRIMA US-Feasibility Study in Atrophic Dry AMD - Age Related Macular Degeneration (PRIMA-FS-US) |
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Link to ClinicalGov |
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Device evaluated |
PRIMA, a novel miniature wireless photovoltaic sub-retinal implant |
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Indication |
Dry-age related macular degeneration |
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Number of patients |
5 |
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STATUS : |
RECRUITING |
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Details |
In UPMC Pittsburgh (USA), recruitment is fully active, please check the main inclusion criteria below and contact the |
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Participating center |
UPMC : UPMC Eye Center (PA, USA)
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Evaluation criteria
The principal evaluation criterion of the trial is safety and performance evaluation: Elicitation of visual perception by electrical stimulation of the PRIMA implant and complication rates, at 12 months after implantation. Secondary endpoints include visual perception at 3,6,9,18, 24 and 36 months,visual acuity measured by ETDRS, near visual acuity measured by FrACT at 3,6,9,12,18,24 and 36 months, and reading acuity measured at 12, 18, 24 and 36 months after implantation.
Main inclusion criteria
- · Is 60 years or older at the date of enrollment;
- · Has a confirmed diagnosis of advanced dry age related macular degeneration with an atrophy size of at least 3 optic disc diameters;
- . Has best corrected visual acuity of logMAR 1.3 (20/400) or worse in both eyes measured by ETDRS;
- . Has a central scotoma in the study eye with no perception at 0 dB on MP-1 micro-perimetry scale;
- . Has a refraction of study eye between -3 and + 4 (limits included) for patients with IOL (there is no refraction criteria for phakic patients);
Contact
Contact : Joseph Martel, MD
Pittsburgh, Pennsylvania, United States, 15213
Tel: 412-647-2200
