title: Argus II retinal prosthesis implantation with scleral flap and autogenous temporalis fascia as alternative patch graft material: a 4-year follow-up.
abstract: BACKGROUND
  The Argus II retinal prosthesis is composed of an epiretinal electrode array positioned over the macula and connected to an extrascleral electronics case via a silicone cable, running through a sclerotomy. During implantation, the manufacturer recommends to cover the sclerotomy site with a patch of processed human pericardium to prevent postoperative hypotony and conjunctival erosion by the underlying electronics case. Due to biomedical regulations prohibiting the use of this material in France, we developed an alternative technique combining a scleral flap protecting the sclerotomy and an autogenous graft of superior temporalis fascia overlying the electronics case.
  
  
  METHODS
  The purpose of this study is to describe the 4-year outcomes of this modified procedure in three subjects who underwent Argus II Retinal Prosthesis System implantation. Clinical data consisting of intraocular pressure measurements and tolerance in terms of conjunctival erosion or inflammation were retrospectively assessed over a 4-year postoperative follow-up.
  
  
  RESULTS
  None of the three patients implanted with the modified technique developed ocular hypotony over 4 years. A normal, transient conjunctival inflammation occurred during the first postoperative month but conjunctival erosion was not observed in any of the three patients over 4 years. Four years after implantation, the autogenous temporalis fascia graft remained well tolerated and the retinal prosthesis was functional in all three patients.
  
  
  CONCLUSIONS
  The combination of an autograft of superficial temporalis fascia and a scleral flap efficiently prevented leakage through the sclerotomy site, ocular hypotony, and conjunctival erosion by the extrascleral electronics case. This modified technique is suitable for the implantation of existing and forthcoming retinal prostheses. Superficial temporalis fascia may also be used as alternative to commercial tectonic tissues for scleral wound repair in clinical settings where they are not available.
authors: INSERM and DHOS, CHNO des Quinze-Vingts; Sorbonne Universités, UPMC Univ Paris 6, Institut de la Vision.
authors: Alexandre
authors: A
authors: Matet
authors: INSERM and DHOS, CHNO des Quinze-Vingts; Sorbonne Universités, UPMC Univ Paris 6, Institut de la Vision.
authors: Nawel
authors: N
authors: Amar
authors: INSERM and DHOS, CHNO des Quinze-Vingts; Sorbonne Universités, UPMC Univ Paris 6, Institut de la Vision; INSERM; CNRS, Paris, France.
authors: Saddek
authors: S
authors: Mohand-Said
authors: INSERM and DHOS, CHNO des Quinze-Vingts; Sorbonne Universités, UPMC Univ Paris 6, Institut de la Vision; INSERM; CNRS, Paris, France; Institute of Ophthalmology, University College London, London, UK; Fondation Ophtalmologique Adolphe de Rothschild; Académie des Sciences, Institut de France, Paris, France.
authors: José-Alain
authors: JA
authors: Sahel
authors: INSERM and DHOS, CHNO des Quinze-Vingts; Sorbonne Universités, UPMC Univ Paris 6, Institut de la Vision.
authors: Pierre-Olivier
authors: PO
authors: Barale
keywords: conjunctiva; intraocular pressure; retinitis pigmentosa; surgical procedure; visual prosthesis