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Y. Djalali-Talab, G. Roessler, T. Laube, C. Brockmann, P. Walter, EPIRET 3 Study Group; Angiographic Findings Following Tack Fixation of a Wireless Epiretinal Retina Implant Device in Blind RP Patients. Invest. Ophthalmol. Vis. Sci. 2010;51(13):3022. doi: https://doi.org/.
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© ARVO (1962-2015); The Authors (2016-present)
Using retinal tacks for the fixation of polyimide stimulator foils as the basic substrate of epiretinal prostheses may cause retinal or choroidal alterations like retinal proliferations or choroidal neovascularizations (CNV). During the prospective trial to evaluate the safety and efficacy of a wireless intraocular retinal implant (EPIRET3) we investigated alterations in angiographic findings during implantation and after explantation of the device to detect potential vascular pathologies at the fixation site or elsewhere.
The implant is a remotely controlled fully intraocular wireless device consisting of a receiver and a stimulator module. During implantation in six patients the stimulator was placed on the retinal surface using retinal tacks. For the detection of possible morphological or vascular alterations committed by the implant, fluorescein angiography (FA) was performed one day before and four weeks after implantation surgery as well as at the final visit five months after explantation.
Following implantation including tack fixation funduscopy and FA did not reveal any evidence of vascular pathologies or CNV respectively after four weeks. At the six-month follow-up visit we found a mild epiretinal gliosis formation in two patients. Due to a retinal break occurred during explantation, followed by temporary silicone-oil endotamponade, one patient showed a focal proliferative vitreoretinopathy (PVR) reaction without activity while there was no evidence for a CNV formation in that area.
The FA findings confirm our previous results on the safety of the EPIRET3 system which was well tolerated in all patients. Long-term follow-up examination may deliver further information with special regard on possible alterations at the tack fixation site.
Clinical Trial: :
DE/CA21/A/07/Dr.Schmidt IOL/EPIRET III
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