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G. Roessler, T. Laube, C. Brockmann, N. Bornfeld, P. Walter, EPIRET3 Study Group; Long Term Follow-Up Examinations After Semichronical Testing of an Intraocular Epiretinal Prosthesis. Invest. Ophthalmol. Vis. Sci. 2010;51(13):3038.
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To evaluate ocular findings two years after implantation and removal surgery of EPIRET3 retinal implants in six blind subjects.
The completely wireless EPIRET3 device was implanted epiretinally onto the posterior pole in six blind subjects suffering from Retinitis pigmentosa enrolled in a prospective exploratory clinical trial. According to the schedule of the clinical trial explantation was performed four weeks after implantation. As one patient died of cancer in the meantime five patients appeared at the follow-up visit after two years and underwent clinical examinations including visual acuity (VA), slit lamp examination, intraocular pressure (IOP) and funduscopy.
In all patients the preoperative VA (no light perception to hand movements) remained unaffected. All eyes were aphakic and the IOP was normal without antiglaucomatous therapy. Funduscopy showed mild to moderate gliosis formation at the tack fixation site which compared to earlier findings did not reveal any further alteration. In one eye where due to a central retinal break a temporary silicone oil endotamponade was installed we saw stable conditions following oil removal as well.
Our findings confirm our recent reports on the feasibility and safety of implantation and explantation surgery utilizing retinal tacks for the fixation of our epiretinal device onto the posterior pole.
Clinical Trial: :
DE/CA21/A/07/Dr. Schmidt IOL/EPIRET III
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