Angiographic findings following tack fixation of a wireless epiretinal retina implant device in blind RP patients

Abstract

The FA findings confirm our previous results on the safety of the EPIRET3 system, which was tolerated in all patients but revealed a certain risk profile in regard to the stimulator fixation. While there was no evidence for newly occurred CME or CNV during the follow-up visits, nevertheless gliosis or even PVR reaction at the tack's fixation site suggests the need to develop alternative fixation procedures of epiretinal stimulators.

Safety Studies for a 44-Channel Suprachoroidal Retinal Prosthesis: A Chronic Passive Study

“…There are reports of localized photoreceptor loss/disruption overlying subretinal implants [37][38][39] and localized retinal damage and/or gliosis from tacking or contact pressure with epiretinal implantation. 40,41 Hence, the surgical complications noted in the current study are not as severe as some of the complications recognized by other surgical approaches.…”

Retinal implants

“…Their subjects were capable of discriminating the orientation and location of electrode pairs[29]. This same group also reported surgical outcomes[66], which are of special interest since the implant was designed to be removed from its support posts without damage to the underlying retina.…”

Electronic Approaches to Restitute Vision in Patients with Neurodegenerative Diseases of the Retina

“…Clinically, there were some retinal detachments needing surgical interventions, isolated cystoid macular edema or epiretinal membranes, as well as proliferations around the retinal tacks [33,35,36,38]. In the case of epiretinal implants no signs of vascular ischemia in fluorescein angiography were described, albeit during only 4 weeks after implantation [38]. …”

“…The safety of epiretinal implants has been published from two human application trials with follow-ups of 4 weeks to over 2 years [33,35,36,38] and an animal study observation with implantation time of 3-8 weeks [34]. Clinically, there were some retinal detachments needing surgical interventions, isolated cystoid macular edema or epiretinal membranes, as well as proliferations around the retinal tacks [33,35,36,38].…”