1. Conferences Overview
    2. 38. Internationaler Kongress der Deutschen Ophthalmochirurgie (DOC)
    3. Surgical implantation and multimodal imaging of the PRIMA subretinal neurostimulation system in geographic atrophy: Safety and clinical insights
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38. Internationaler Kongress der Deutschen Ophthalmochirurgie (DOC)


18.-20.06.2026
Nürnberg

Meeting Abstract

Surgical implantation and multimodal imaging of the PRIMA subretinal neurostimulation system in geographic atrophy: Safety and clinical insights

Salvatore Grisanti - Klinik für Augenheilkunde, Universität zu Lübeck, Lübeck
Lars-Olof Hattenbach - Klinikum Ludwigshafen, Ludwigshafen am Rhein, Ludwigshafen
Mahi Muqit - Moorfields Eye Hospital, London, Vereinigtes Königreich
Yannick Le Mer - Hôpital Fondation A. de Rothschild, Department of Ophthalmology, Paris, Frankreich
Andreas Cusumano - University of Rome, Department of Experimental Medicine, Rom, Italien
José-Alain Sahel - University of Pittsburgh, Department of Ophthalmology, Pittsburgh, USA
Boris V. Stanzel - Knappschaft Klinikum Saar, Augenklinik Sulzbach, Sulzbach
Peter Szurman - Knappschaft Klinikum Saar, Augenklinik Sulzbach, Sulzbach
Karl U. Bartz-Schmidt - Eye Hospital Tübingen, Department of Ophthalmology, Tübingen
Nicole Eter - Universitätsklinikum Münster, Medical Center, Department of Ophthalmology, Münster
Armin Wolf - Universitätsklinikum Ulm, Klinik für Augenheilkunde, Klinikbereich Michelsberg, Ulm
Frank Brodie - University of California, Ophthalmology, San Francisco, CA, USA
Ralf Hornig - Science Corporation, Alameda, CA, USA
Frank G. Holz - University of Bonn, Department of Ophthalmology, Bonn

Text

Objectives: The PRIMAvera pivotal trial demonstrated that the subretinal photovoltaic PRIMA implant can restore formed vision in patients with advanced geographic atrophy. This substudy aims to characterize multimodal retinal imaging features relevant for patient selection and to evaluate longitudinal structural retinal changes following subretinal implantation of the PRIMA device in geographic atrophy secondary to age-related macular degeneration.

Methods: Multimodal retinal imaging included spectral-domain optical coherence tomography (SD-OCT), fundus autofluorescence (FAF), color fundus photography (CFP), and fluorescein angiography (FA). Imaging was performed at baseline and at 4 weeks, as well as at 3, 6, 9, and 12 months postoperatively. Analyses focused on retinal architecture overlying the implant, implant positioning, and postoperative structural changes. Quantitative FAF analysis was conducted to assess longitudinal changes in atrophic lesion size.

Results: Thirty-eight implanted eyes were included. Baseline imaging confirmed advanced geographic atrophy with relative preservation of inner retinal layers within the intended implantation area. Multimodal imaging demonstrated that subretinal placement of the implant over the retinal pigment epithelium did not result in significant alterations of the inner retinal architecture, with no evidence of progressive inner retinal thinning over 12 months. Postoperatively, a low incidence of complications was observed, including macular hole formation in 4/38 eyes and choroidal neovascularization in 2/38 eyes. As expected, FAF imaging revealed variable degrees of atrophic changes related to subretinal surgical delivery. Overall, these imaging findings provide valuable insights for postoperative assessment and management of patients receiving the PRIMA implant.

Conclusions: Multimodal imaging demonstrates preservation of inner retinal structure following subretinal PRIMA implantation and offers important guidance for both patient selection and postoperative monitoring.