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Implantation and explantation of a wireless epiretinal retina implant device: observations during the EPIRET3 prospective clinical trial.

Abstract：

PURPOSE:Visual sensations in patients with blindness and retinal degenerations may be restored by electrical stimulation of retinal neurons with implantable microelectrode arrays. A prospective trial was initiated to evaluate the safety and efficacy of a wireless intraocular retinal implant (EPIRET3) in six volunteers with blindness and RP. METHODS:The implant is a remotely controlled, fully intraocular wireless device consisting of a receiver and a stimulator module. The stimulator is placed on the retinal surface. Data and energy are transmitted via an inductive link from outside the eye to the implant. Surgery included removal of the lens, vitrectomy, and implantation of the EPIRET3 device through a corneal incision. The clinical outcome after implantation and explantation of the device was determined. The implant was removed after 4 weeks, according to the study protocol. RESULTS:Implantation was successful in all six patients. While the anterior part was fixed with transscleral sutures, the stimulating foil was placed onto the posterior pole and fixed with retinal tacks. The implant was well tolerated, causing temporary moderate postoperative inflammation, whereas the position of the implant remained stable until surgical removal. In all cases explantation of the device was performed successfully. Adverse events were a sterile hypopyon effectively treated with steroids and antibiotics in one case and a retinal break in a second case during explantation requiring silicone oil surgery. CONCLUSIONS:The EPIRET3 system can be successfully implanted and explanted in patients with blindness and RP. The surgical steps are feasible, and the postoperative follow-up disclosed an acceptable range of adverse events.

journal_name

Invest Ophthalmol Vis Sci

journal_title

Investigative ophthalmology & visual science

authors

Roessler G,Laube T,Brockmann C,Kirschkamp T,Mazinani B,Goertz M,Koch C,Krisch I,Sellhaus B,Trieu HK,Weis J,Bornfeld N,Röthgen H,Messner A,Mokwa W,Walter P

doi

10.1167/iovs.08-2752

subject

Has Abstract

pub_date

2009-06-01 00:00:00

pages

3003-8

issue

eissn

0146-0404

issn

1552-5783

pii

iovs.08-2752

journal_volume

pub_type

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Implantation and explantation of a wireless epiretinal retina implant device: observations during the EPIRET3 prospective clinical trial.