Restoration of Central Vision With the PRIMA System in Patients With Atrophic AMD (NCT04676854) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Restoration of Central Vision With the PRIMA System in Patients With Atrophic AMD
France38 participantsStarted 2020-11-24
Plain-language summary
The objective of this study is to evaluate the efficacy and safety of the PRIMA System in patients with atrophic AMD. Eligible subjects will be implanted with the PRIMA Implant. The subjects will be assessed with various visual function and functional vision tests at defined timepoints throughout the clinical investigation with the PRIMA System (Implant and Visual Processor).
Who can participate
Age range60 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Is 60 years or older at the date of inclusion;
* Has a confirmed diagnosis of geographic atrophy due to AMD in both eyes;
* The study eye has best corrected visual acuity of logMAR 1.2 (20/320) or worse as measured by ETDRS test;
* Has an atrophic patch in the study eye including the fovea of at least the implant size (\>4.5 mm2 and \>2.4 mm in minimum diameter);
* Understands the constraints of the study and accepts to present for all scheduled follow-up visits;
* Patient signed informed consent
Exclusion Criteria:
* Has cataract in the study eye (with LOCS III scale NO, NC, C or P\>1); (these patients will be asked to have cataract surgery performed prior to enrollment; all other patients will get IOL replacement during the PRIMA implantation);
* Underwent intra ocular lens implantation in the study eye within the last month ;
* Has a highly myopic study eye (\>26 mm AP);
* Has a highly hyperopic study eye (\<20 mm AP);
* Has no light perception in either eye;
* Has a history of documented choroidal neovascularization in either eye;
* Has any signs of exudative AMD including exudative AMD with detachment of retinal pigment epithelium in the central visual field of the study eye;
* Has an implanted telescope in one eye;
* Has a black IOL in the study eye;
* Has any disease (other than study allowed diseases) or condition that affects retinal function of the study eye or the visual system (e.g., central retinal artery/vein occlusion, end-stage diabeti…
What they're measuring
1
Proportion of subjects with meaningful improvement of visual acuity