Martin Deterre, Claire-Maëlle Fovet, Douglas B. McCreery, Jean-Pierre Hubschman, José-Alain Sahel, Joseph N. Martel, Ralf Hornig, Guillaume Buc, Yannick Le Mer, Philippe Hantraye, Mahiul M. K. Muqit, Elodie Bouillet, Serge Picaud, Céline Nouvel-Jaillard, Jan C. van Meurs, Moorfields Eye Hospital [Londres, Royaume-Uni], University College of London [London] (UCL), University of California [Los Angeles] (UCLA), University of California (UC), Institut de la Vision, Institut National de la Santé et de la Recherche Médicale (INSERM)-Sorbonne Université (SU)-Centre National de la Recherche Scientifique (CNRS), Huntington Medical Research Institutes [Pasadena, CA, États-Unis], Rotterdam Eye Hospital [Rotterdam, Pays-Bas], Erasmus University Medical Center [Rotterdam] (Erasmus MC), Pixium Vision [Paris], Service MIRCEN (MIRCEN), Université Paris-Saclay-Centre National de la Recherche Scientifique (CNRS)-Institut de Biologie François JACOB (JACOB), Direction de Recherche Fondamentale (CEA) (DRF (CEA)), Commissariat à l'énergie atomique et aux énergies alternatives (CEA)-Commissariat à l'énergie atomique et aux énergies alternatives (CEA)-Direction de Recherche Fondamentale (CEA) (DRF (CEA)), Commissariat à l'énergie atomique et aux énergies alternatives (CEA)-Commissariat à l'énergie atomique et aux énergies alternatives (CEA), Centre Hospitalier National d'Ophtalmologie des Quinze-Vingts (CHNO), University of Pittsburgh School of Medicine, Pennsylvania Commonwealth System of Higher Education (PCSHE), Fondation Ophtalmologique Adolphe de Rothschild [Paris], The studies were funded in part by the SightAgain project under the Structural R&D Projects for Competitiveness (PSPC) and Investment for the Future (PIA) funding, managed by Bpifrance. They were partly conducted at the Institut de la Vision within the framework of the LABEX LIFESENSES [ANR-10-LABX-65] and IHU FOReSIGHT [ANR-18-IAHU-0001] supported by French state funds managed by the Agence Nationale de la Recherche within the Investissements d’Avenir program., ANR-11-IDEX-0004,SUPER,Sorbonne Universités à Paris pour l'Enseignement et la Recherche(2011), ANR-18-IAHU-0001,FOReSIGHT,Enabling Vision Restoration(2018), University of California, Centre National de la Recherche Scientifique (CNRS)-Sorbonne Université (SU)-Institut National de la Santé et de la Recherche Médicale (INSERM), Université Paris-Saclay-Institut de Biologie François JACOB (JACOB), Bodescot, Myriam, Sorbonne Universités à Paris pour l'Enseignement et la Recherche - - SUPER2011 - ANR-11-IDEX-0004 - IDEX - VALID, Enabling Vision Restoration - - FOReSIGHT2018 - ANR-18-IAHU-0001 - IAHU - VALID, Vavvas, Demetrios G, and Ophthalmology
Author(s): Muqit, Mahiul MK; Hubschman, Jean Pierre; Picaud, Serge; McCreery, Douglas B; van Meurs, Jan C; Hornig, Ralf; Buc, Guillaume; Deterre, Martin; Nouvel-Jaillard, Celine; Bouillet, Elodie; Fovet, Claire-Maelle; Hantraye, Philippe; Sahel, Jose; Martel, Joseph N; Le Mer, Yannick | Abstract: PURPOSE:To evaluate the surgical technique for subretinal implantation of two sizes of PRIMA photovoltaic wireless microchip in two animal models, and refine these surgical procedures for human trials. METHODS:Cats and Macaca fascicularis primates with healthy retina underwent vitrectomy surgery and were implanted with subretinal wireless photovoltaic microchip at the macula/central retina. The 1.5mm PRIMA chip was initially studied in feline eyes. PRIMA implant (2mm,1.5mm sizes) arrays were studied in primates. Feasibility of subretinal chip implantation was evaluated with a newly-developed surgical technique, with surgical complications and adverse events recorded. RESULTS:The 1.5mm implant was placed in the central retina of 11 feline eyes, with implantation duration 43-106 days. The 1.5mm implant was correctly positioned into central macula of 11 primate eyes, with follow-up periods of minimum 6 weeks (n = 11), 2 years (n = 2), and one eye for 3 years. One primate eye underwent multi-chip 1.5mm implantation using two 1.5mm chips. The 2mm implant was delivered to 4 primate eyes. Optical coherence tomography confirmed correct surgical placement of photovoltaic arrays in the subretinal space in all 26 eyes. Intraoperative complications in primate eyes included retinal tear, macular hole, retinal detachment, and vitreous hemorrhage that resolved spontaneously. Postoperatively, there was no case of significant ocular inflammation in the 1.5mm implant group. CONCLUSIONS:We report subretinal implantation of 1.5mm and 2mm photovoltaic arrays in the central retina of feline and central macula of primate eyes with a low rate of device-related complications. The in vivo PRIMA implantation technique has been developed and refined for use for a 2mm PRIMA implant in ongoing human trials.