Laboratory and clinical reliability of conformally coated subretinal implants.

"Conflict of interests Renate Daschner, Udo Greppmaier, Martin Kokelmann, Sandra Rudorf and Ralf Rudorf are employees of Retina Implant AG (Reutlingen, Germany). Walter G. Wrobel is an employee and owns stocks of Retina Implant AG (Reutlingen, Germany). Sebastian Schleehauf has been an employee of Retina Implant AG (Reutlingen, Germany) during conduct of the study."

"The multicenter trial (www.clinicaltrials.gov, NCT0102 4803) and its interim results are described in detail by Stingl et al. (). They showed, that with the retinal implant Alpha IMS a rudimentary vision could be restored in patients, that are blind from hereditary degenerations of photoreceptors. Patients were able to localise and recognize high-contrast objects. In this publication we focus on the clinical reliability of the two implants. Alpha IMS was implanted in 29 patients (in 2010-2013), but due to one reimplantation 30 implant systems are considered in the evaluation. Alpha AMS on the other hand was implanted in 10 patients during the multicenter trial (since 2014) and additionally in five patients as part of an ongoing clinical trial at NIHR Oxford (National Institute for Health Research, Oxford, GB, NCT02720640). For evaluation of the reliability both trials are analyzed in one dataset, since the device (Alpha AMS) is the same. One additional implantation of Alpha AMS that is not part of a clinical trial was also included for the calculation of the clinical reliability."