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).
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
38
Implantation of PRIMA, Vision training, follow up
Hôpital Pellegrin
Bordeaux, France
Proportion of subjects with meaningful improvement of visual acuity
Proportion of subjects with an improvement of visual acuity of logMAR 0.2 or more from baseline to 12 months
Time frame: 12 months
Serious Adverse Events
Number and severity of device and procedure related serious adverse events at 12 months follow-up
Time frame: 12 months
Proportion of subjects with meaningful improvement of visual acuity
Proportion of subjects with an improvement of visual acuity of logMAR 0.2 or more at 6, 24 and 36 months compared to baseline
Time frame: 6, 24, 36 months
Improvement of visual acuity
Mean improvement of visual acuity at 6, 12, 24 and 36 months compared to baseline
Time frame: 6, 12, 24, 36 months
Quality of life measured by IVI
IVI-Impact of Vision Impairment questionnaire (quality of life based on patient reported outcome of functional vision, participation in vision-related daily living activities and emotional well-being) at 6, 12, 24 and 36 months
Time frame: 6, 12, 24, 36 months
Central visual perception
Central visual perception with PRIMA at 12 months compared to central visual perception at baseline
Time frame: 12 months
Adverse Events
Number and severity of procedure and device related adverse events at 6, 12, 24 and 36 months follow-up
Time frame: 6, 12, 24, 36 months
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Centre hospitalier intercommunal de Créteil - Service Ophtalmologie
Créteil, France
Hôpital de la Croix-Rousse CHU de LYON
Lyon, France
Centre Monticelli Paradis
Marseille, France
CHU de Nantes
Nantes, France
Hopital des Quinze Vingts
Paris, France
Fondation Ophtalmologique A. De Rothschild
Paris, France
Universitätsklinikum Aachen, Klinik fuer Augenheilkunde
Aachen, Germany
Universitäts-Augenklinik Bonn
Bonn, Germany
Universitätsklinikum Hamburg-Eppendorf (UKE), Augenklinik
Hamburg, Germany
...and 11 more locations
Change of natural visual acuity
Change of natural visual acuity without the PRIMA Glasses
Time frame: 6, 12, 24, 36 months
Proportion of compliant implantations
Number of subjects with PRIMA implant placed according protocol
Time frame: 4 weeks after implantation