Clinical Trial
Journal Article
Research Support, Non-U.S. Gov't
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Optical Coherence Tomography in Patients With the Subretinal Implant Retina Implant Alpha IMS.

BACKGROUND AND OBJECTIVE: The aim of this study was to assess changes in retinal structure and thickness after subretinal implantation of the Retina Implant Alpha IMS (Retina Implant AG, Reutlingen, Germany).

PATIENTS AND METHODS: Spectral-domain optical coherence tomography (SD-OCT) imaging was performed to assess the structure and thickness of the retina anterior to the microphotodiode array preoperatively, within 6 weeks and 6 months ± 1 month after implantation. Thickness measurements were performed using the distance tool of the built-in software. Three thickness measurements were performed in each of the four quadrants of the retina on the microchip within 6 weeks and 6 months ± 1 month after implantation.

RESULTS: The mean ± standard deviation change in retinal thickness from within 6 weeks to 6 months ± 1 month after implantation in all four quadrants combined was 24 μm ± 68 μm. None of the tested variables (location, time, or their interaction) had a statistically significant effect on the mean retinal thickness (P = .961, P = .131, and P = .182, respectively; n = 19).

CONCLUSION: The authors report on qualitative and quantitative findings in retinal structure in 27 patients after subretinal implantation of the Retina Implant Alpha IMS using OCT technology. No significant changes of retinal thickness could be observed in a period of 6 months after surgery. With more patients receiving subretinal implants and with advanced OCT technology, the data set will be extended to study possible changes in retinal structure in finer detail. [Ophthalmic Surg Lasers Imaging Retina. 2017;48:993-999.].

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