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Master Thesis

Résultats anatomiques de l’implantation de la prothèse épi rétinienne Argus II : étude prospective multicentrique chez dix huit patients français dans le cadre du forfait innovation

Abstract : Purpose: Assess the safety of Argus II epiretinal prosthesis (SecondSight Medical Products Inc., Sylmar, California, USA) during the first 6 months, it stability onto the retinal, and factors affecting threshold. Methods: This prospective study was conducted between November 2014 and July 2016 among eighteen French patients suffering from outer retinal degeneration (BCVA < 2,9 LogMAR) which received Argus II implant. Surgical procedure was modified with systematic performing of a scleral flap and autogenous graft of fascia temporalis in order to cover the main sclerotomy. Follow up was performed at day 1, day 7, month 1, month 3 and month 6. Patient went through complete ocular examination with retinophotography and SD-OCT. Assessing safety was conducted by registration of preoperative data, IOP variations in the first six months, and serious adverse events. Stability of the device onto the retina was assessed on the retinophotography by measuring and comparing the tilt of the device between the first month and the sixth month. Factors affecting threshold were the electrode retina distance and electrode fovea distance. Results : Eighteen French patients underwent surgical implantation between November 2014 and January 2016. 72% didn’t experience any serious adverse event. Scleral flap and autgenous graft of fascia temporalis was used in 100 % of cases and was successful in preventing ocular hypotony and conjunctival erosion. Device stability was not achieve with the presence of a median rotation of 2,01° [0.97 ; 3.61] (p<0,001). Linear regression was used to study the relation between threshold and electrode retina distance and electrode fovea distance. Electrode retina distance appeared to by the main factor affecting threshold. Conclusion : Argus II prosthesis has a good safety profile, and the use of scleral flap with covering of autogenous fascia temporalis is efficient in limiting the occurrence of hypotony and/or conjunctival issues. Stability of the device was not achieve using one tack, and targeting low threshold needed the electrode retina distance to be as small as possible.
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Master Thesis
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https://dumas.ccsd.cnrs.fr/dumas-01391446
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Submitted on : Thursday, November 3, 2016 - 12:31:29 PM
Last modification on : Wednesday, August 23, 2017 - 4:41:04 PM
Long-term archiving on: : Saturday, February 4, 2017 - 1:13:39 PM

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Marc Govare. Résultats anatomiques de l’implantation de la prothèse épi rétinienne Argus II : étude prospective multicentrique chez dix huit patients français dans le cadre du forfait innovation. Médecine humaine et pathologie. 2016. ⟨dumas-01391446⟩

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