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Implantation and explantation of a wireless epiretinal retina implant device: observations during the EPIRET3 prospective clinical trial.
Invest Ophthalmol Vis Sci 2009; 50(6):3003-8IO

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.

Authors+Show Affiliations

Departments of Ophthalmology, RWTH Aachen University, Aachen, Germany.No affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Clinical Trial
Journal Article
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

19420330

Citation

Roessler, Gernot, et al. "Implantation and Explantation of a Wireless Epiretinal Retina Implant Device: Observations During the EPIRET3 Prospective Clinical Trial." Investigative Ophthalmology & Visual Science, vol. 50, no. 6, 2009, pp. 3003-8.
Roessler G, Laube T, Brockmann C, et al. Implantation and explantation of a wireless epiretinal retina implant device: observations during the EPIRET3 prospective clinical trial. Invest Ophthalmol Vis Sci. 2009;50(6):3003-8.
Roessler, G., Laube, T., Brockmann, C., Kirschkamp, T., Mazinani, B., Goertz, M., ... Walter, P. (2009). Implantation and explantation of a wireless epiretinal retina implant device: observations during the EPIRET3 prospective clinical trial. Investigative Ophthalmology & Visual Science, 50(6), pp. 3003-8. doi:10.1167/iovs.08-2752.
Roessler G, et al. Implantation and Explantation of a Wireless Epiretinal Retina Implant Device: Observations During the EPIRET3 Prospective Clinical Trial. Invest Ophthalmol Vis Sci. 2009;50(6):3003-8. PubMed PMID: 19420330.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Implantation and explantation of a wireless epiretinal retina implant device: observations during the EPIRET3 prospective clinical trial. AU - Roessler,Gernot, AU - Laube,Thomas, AU - Brockmann,Claudia, AU - Kirschkamp,Thomas, AU - Mazinani,Babac, AU - Goertz,Michael, AU - Koch,Christian, AU - Krisch,Ingo, AU - Sellhaus,Bernd, AU - Trieu,Hoc Khiem, AU - Weis,Joachim, AU - Bornfeld,Norbert, AU - Röthgen,Harald, AU - Messner,Arthur, AU - Mokwa,Wilfried, AU - Walter,Peter, Y1 - 2009/05/06/ PY - 2009/5/8/entrez PY - 2009/5/8/pubmed PY - 2009/6/12/medline SP - 3003 EP - 8 JF - Investigative ophthalmology & visual science JO - Invest. Ophthalmol. Vis. Sci. VL - 50 IS - 6 N2 - 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. SN - 1552-5783 UR - https://www.unboundmedicine.com/medline/citation/19420330/Implantation_and_explantation_of_a_wireless_epiretinal_retina_implant_device:_observations_during_the_EPIRET3_prospective_clinical_trial_ L2 - http://iovs.arvojournals.org/article.aspx?doi=10.1167/iovs.08-2752 DB - PRIME DP - Unbound Medicine ER -