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

  • Gernot RoesslerEmail author
  • Thomas Laube
  • Claudia Brockmann
  • Thomas Kirschkamp
  • Babac Mazinani
  • Johannes Menzel-Severing
  • Norbert Bornfeld
  • Peter Walter
  • The EPIRET Group
Retinal Disorders

Abstract

Background

The fixation of polyimide stimulator foils as the basic substrate of epiretinal prostheses by using retinal tacks may cause retinal or choroidal alterations such as retinal proliferations or choroidal neovascularizations. During the prospective trial for the semichronical testing 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.

Methods

As the final step of the implantation surgery in six blind 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 1 day before and 4 weeks after implantation surgery, as well as at the final visit 5 months after explantation.

Results

Following implantation surgery funduscopy and FA did not reveal any evidence of either vascular pathologies or choroidal neovascularisations (CNV), in addition, no cystoid macular edema (CME) occurred after 4 weeks. At the 6-month follow-up visit, we found a mild epiretinal gliosis formation in four patients. In one patient a retinal break occurred during explantation, requiring a temporary silicone-oil endotamponade. At the final visit, we observed a focal proliferative vitreoretinopathy (PVR) reaction without activity, while there was no evidence for a CNV formation in that area.

Conclusions

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.

Keywords

Retinal prosthesis Retinitis pigmentosa Fluorescein angiography Retinal tack 

Notes

Acknowledgements

The authors thank all co-workers of the EPIRET work group.

Grants

This work was supported by BMBF grants: 01IN501B, 01IN501F9, 01IN501K7, 01KP0004, 01KP0006, 01KP0402, 01KP0404, 01KP0405, 01PK0001

Supplementary material

417_2011_1653_MOESM1_ESM.doc (25 kb)
ESM 1 (DOC 25 kb)

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Copyright information

© Springer-Verlag 2011

Authors and Affiliations

  • Gernot Roessler
    • 1
    Email author
  • Thomas Laube
    • 2
  • Claudia Brockmann
    • 2
  • Thomas Kirschkamp
    • 1
  • Babac Mazinani
    • 1
  • Johannes Menzel-Severing
    • 1
  • Norbert Bornfeld
    • 2
  • Peter Walter
    • 1
  • The EPIRET Group
  1. 1.Department of OphthalmologyRWTH Aachen UniversityAachenGermany
  2. 2.Department of OphthalmologyUniversity of Duisburg–EssenEssenGermany

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