NL-OMON54164
Recruiting
Not Applicable
Restoration of central vision with the PRIMA System in Patients with Atrophic Age-Related Macular Degeneration - PRIMAvera
Pixium Vision SA0 sites10 target enrollmentTBD
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Pixium Vision SA
- Enrollment
- 10
- Status
- Recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •A subject will be included in the study provided he or she:
- •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\.5mm^2 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
- •A subject will be excluded from the study if he or she:
- •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
- •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
Outcomes
Primary Outcomes
Not specified
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