Feasibility Study of Compensation for Blindness With the PRIMA System in Patients With Dry Age Related Macular Degeneration

Science Corporation1 site in 1 country5 target enrollmentNovember 6, 2017

ConditionsDry Age-related Macular Degeneration

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Dry Age-related Macular Degeneration
Sponsor: Science Corporation
Enrollment: 5
Locations: 1
Primary Endpoint: Elicitation of perception
Status: Completed
Last Updated: last year

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

In this study, the principle functionality of the device will be tested in humans for the first time. The study will evaluate the extent to which patients with atrophic dry age related macular degeneration (AMD) have evoked light perception using the implant.

Detailed Description

In this study subjects are provided with a PRIMA sub-retinal implant in one eye. A camera integrated in the external components of the implant captures visual information of the environment, this information is processed by a pocket processor and then transmitted via projected IR light onto the implant. The implant received the projected IR light and stimulates the nerve cells of the retina. Interim analysis will be performed at 6 months after implantation.

Registry

clinicaltrials.gov

Start Date

November 6, 2017

End Date

December 12, 2024

Last Updated

last year

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Science Corporation

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Is 60 years or older at the date of enrolment;
•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 the study eye of logMAR 1.3 (20/400) or worse measured by ETDRS;
•Has no foveal perception measured by micro-perimetry in the study eye (≤ 4 dB on Opko scale or equivalent) ;
•Has a study eye that is able to perceive light;
•Has useful vision on the non-study eye;
•Has a refraction of study eye between -3 and + 4 (limits included) for patient with IOL (there is no refraction criteria for patients with natural lens);
•Understands and accepts the obligation to present for all schedule follow-up visits.
•Patient signed informed consent

Exclusion Criteria

•Has cataracts that may influence the visual function of the study eye;
•Has an aphakic study eye
•Had cataract surgery in the last 1 month;
•Active sub-macular choroidal neovascularization in the study eye;
•Has any disease (other than study allowed diseases) or condition that affects retinal function of the study eye (e.g., central retinal artery/vein occlusion, end-stage diabetic retinopathy, retinal detachment, infectious or inflammatory retinal disease, severe glaucoma, optic neuropathy, myopic chorio-retinal atrophy etc.);
•Has an implanted telescope in one eye;
•Has any disease or condition that prevents adequate examination of the study eye including, but not limited to, corneal degeneration that cannot be resolved prior to implantation. Note, that this criterion is also important for the function of the implant;
•Has an endothelia cell count of less than 1000 cells/mm² in the study eye;
•Suffers from nystagmus;
•Has any disease or condition that precludes the understanding or communication of the informed consent, study requirements or test protocols (e.g., deafness, severe multiple sclerosis, amyotrophic lateral sclerosis, severe neuritis, etc);