USA (Pittsburgh) feasibility study
Feasibility clinical research study to assess the PRIMA bionic vision system with implantable wireless sub-retinal microchip for advanced atrophic dry age-related macular degeneration
The PRIMA-FS-US clinical research trial is recruiting participants at Pittsburgh UPMC EYE CENTER
Please call the
following number: 412 647 3434
Indication
Advanced Atrophic Dry Age-related Macular Degeneration (dry-AMD)
Device
PRIMA bionic vision system, including a totally wireless implantable photovoltaic sub-retinal microchip, is designed to elicit useful functional prosthetic vision. Click here for more information about the PRIMA system.
Location of participating hospital
The UPMC EYE CENTER
203 Lothrop Street, 8th Floor
Pittsburgh, PA 15213
Principal Investigator: Joseph Martel, MD
Tel: 412 647 3434
Website : www.upmc.com/AMD
ClinicalTrials.gov identifier
NCT 03392324 : PRIMA US-Feasibility Study in Atrophic Dry AMD - Age Related Macular Degeneration (PRIMA-FS-US)
What results are expected?
This is a clinical research study. In a similar feasibility study in France, 5 patients have already been successfully implanted, with positive interim 6 months follow-up results announced by the company in early January, 2019. Interim results to date and simulations demonstrate that the PRIMA bionic vision system can successfully elicit useful functional visual perception from the previously degenerated central atrophic retina, exclusive of residual natural peripheral perception. Subsequent training and reeducation enabled implanted patients to identify visual patterns including numbers and letters.
The achieved prosthetic visual acuity to date is the highest among those published from current prosthetic vision technologies.
Please
check the following link to have more details about
Eligibility Criteria to participate in the clinical research study
Main inclusion criteria :
· Advanced Atrophic dry Age-related Macular Degeneration (dry AMD)
· 60 years or older
·
Visual acuity of logMAR 1.3 (20/400) or worse
· No foveal pereption
Other inclusion and exclusion criteria need to be confirmed by ophthalmologists participating in the clinical study.
Referrals and information
To refer a potential candidate or for further information about the study, please contact the UPMC EYE CENTER in Pittsburgh, PA at:412 647 3434
For additional information visit www.upmc.com/AMD and also see the FAQs, Frequently Asked Questions
