title: Laboratory and clinical reliability of conformally coated subretinal implants.
abstract: Despite recent developments and new treatments in ophthalmology there is nothing available to cure retinal degenerations like Retinitis Pigmentosa (RP) yet. One of the most advanced approaches to treat people that have gone blind due to RP is to replace the function of the degenerated photoreceptors by a microelectronic neuroprosthetic device. Basically, this subretinal active implant transforms the incoming light into electric pulses to stimulate the remaining cells of the retina. The functional time of such devices is a crucial aspect. In this paper the laboratory and clinical reliability of the two active subretinal implants Alpha IMS and Alpha AMS is presented. Based on clinical data the median operating life of the Alpha AMS is estimated to be 3.3 years with a one-sided lower 75 % confidence level of 2.0 years. This data shows a significant improvement of the device lifetime compared to the previous device Alpha IMS which shows a median lifetime of 0.6 years with a lower confidence bound (75 %) of 0.5 years. The results are in good agreement with laboratory data from accelerated aging tests of the implant components, showing an estimated median lifetime for Alpha IMS components of 0.7 years compared to the improved lifetime of Alpha AMS of 4.7 years.
authors.affiliation: Retina Implant AG, Gerhard-Kindler-Strasse 8, 72770, Reutlingen, Germany. renate.daschner@retina-implant.de.
authors.forename: Renate
authors.identifier: 0000-0001-5307-2276
authors.initials: R
authors.lastname: Daschner
authors.affiliation: Retina Implant AG, Gerhard-Kindler-Strasse 8, 72770, Reutlingen, Germany.
authors.forename: Udo
authors.initials: U
authors.lastname: Greppmaier
authors.affiliation: Retina Implant AG, Gerhard-Kindler-Strasse 8, 72770, Reutlingen, Germany.
authors.forename: Martin
authors.initials: M
authors.lastname: Kokelmann
authors.affiliation: Retina Implant AG, Gerhard-Kindler-Strasse 8, 72770, Reutlingen, Germany.
authors.forename: Sandra
authors.initials: S
authors.lastname: Rudorf
authors.affiliation: Retina Implant AG, Gerhard-Kindler-Strasse 8, 72770, Reutlingen, Germany.
authors.forename: Ralf
authors.initials: R
authors.lastname: Rudorf
authors.affiliation: Retina Implant AG, Gerhard-Kindler-Strasse 8, 72770, Reutlingen, Germany.
authors.forename: Sebastian
authors.initials: S
authors.lastname: Schleehauf
authors.affiliation: Retina Implant AG, Gerhard-Kindler-Strasse 8, 72770, Reutlingen, Germany.
authors.forename: Walter G
authors.initials: WG
authors.lastname: Wrobel
mesh_terms: D002986:Clinical Trials as Topic; D006801:Humans; D053208:Kaplan-Meier Estimate; D007753:Laboratories; D011474:Prosthesis Design; D015203:Reproducibility of Results; D012160:Retina; D057488:Visual Prosthesis
keywords: Artificial vision; Clinical reliability; Electronic implants; Neuroprosthetics; Retinitis pigmentosa