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First Human Results With the 256 Channel Intelligent Micro Implant Eye (IMIE 256)

Xu, Huizhuo and Zhong, Xingwu and Pang, Changlin and Zou, Jing and Chen, Wangling and Wang, Xianggui and Li, Shanxiang and Hu, Yuntao and Sagan, Didier S. and Weiss, Philip T. and Yao, Yangyi and Xiang, Jiayi and Dayan, Margot S. and Humayun, Mark S. and Tai, Yu-Chong (2021) First Human Results With the 256 Channel Intelligent Micro Implant Eye (IMIE 256). Translational Vision Science & Technology, 10 (10). Art. No. 14. ISSN 2164-2591. PMCID PMC8556567. doi:10.1167/tvst.10.10.14. https://resolver.caltech.edu/CaltechAUTHORS:20220413-831464000

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Abstract

Purpose: To report on the safety and efficacy of the 256-channel Intelligent Micro Implant Eye epiretinal prosthesis system (IMIE 256). Methods: The IMIE 256 implants were implanted in the right eyes of five subjects with end-stage retinitis pigmentosa. Following implantation, the subjects underwent visual rehabilitation training for 90 days, and their visual performance was evaluated using the grating visual acuity test, Tumbling E visual acuity test, direction of motion, square localization, and orientation and mobility test. To evaluate the safety of the IMIE 256, all adverse events were recorded. Results: Subjects performed significantly better on all evaluations with the IMIE 256 system on as compared with the performance at baseline or with the system off. There was a steady improvement in performance at each observation interval, indicating that the training and/or practice helped the subjects use the IMIE 256. There were two serious adverse events—electrode array movement and low intraocular pressure in one subject, which resolved with surgery. There were no other adverse events observed except those expected in the course of postoperative healing. Conclusions: These results show an improved safety and efficacy profile compared with that of the Argus II implant. Further clinical trials are needed to confirm these results in a larger number of subjects and over longer durations. Translational Relevance: To our knowledge, this study reports the first in-human data from a high-density (256 electrodes) epiretinal implant to restore sight to a subset of blind patients.


Item Type:Article
Related URLs:
URLURL TypeDescription
https://doi.org/10.1167/tvst.10.10.14DOIArticle
http://www.ncbi.nlm.nih.gov/pmc/articles/pmc8556567/PubMed CentralArticle
ORCID:
AuthorORCID
Humayun, Mark S.0000-0002-5830-5208
Tai, Yu-Chong0000-0001-8529-106X
Additional Information:© 2021 The Authors. This work is licensed under a Creative Commons Attribution 4.0 International License. Received: April 30, 2021; Accepted: September 28, 2021; Published: October 27, 2021. Supported by the grants from the Innovation and Entrepreneurship Investment Project of Hunan Province (2019GK5024) and the General Project of Hainan Provincial Natural Science Foundation (820MS152). HX and XZ contributed equally to this article. Disclosure: H. Xu, IntelliMicro (C); X. Zhong, IntelliMicro (C); C. Pang, Golden Eye Bionics (E), IntelliMicro (E); J. Zou, None; W. Chen, None; X. Wang, None; S. Li, None; Y. Hu, None; D.S. Sagan, Golden Eye Bionics (E), IntelliMicro (E); P.T. Weiss, Golden Eye Bionics (E), IntelliMicro (E); Y. Yao, Golden Eye Bionics (E), IntelliMicro (E); J. Xiang, None; M.S. Dayan, None; M.S. Humayun, Golden Eye Bionics (C), IntelliMicro (C); Y.-C. Tai, Golden Eye Bionics (C), IntelliMicro (C).
Funders:
Funding AgencyGrant Number
Innovation and Entrepreneurship Investment Project of Hunan Province2019GK5024
Hainan Provincial Natural Science Foundation820MS152
Subject Keywords:retinitis pigmentosa; retinal degeneration; retinal prosthesis; visual rehabilitation; blindness
Issue or Number:10
PubMed Central ID:PMC8556567
DOI:10.1167/tvst.10.10.14
Record Number:CaltechAUTHORS:20220413-831464000
Persistent URL:https://resolver.caltech.edu/CaltechAUTHORS:20220413-831464000
Official Citation:Xu H, Zhong X, Pang C, Zou J, Chen W, Wang X, Li S, Hu Y, Sagan DS, Weiss PT, Yao Y, Xiang J, Dayan MS, Humayun MS, Tai YC. First human results with the 256 channel intelligent micro implant eye (IMIE 256). Transl Vis Sci Technol. 2021;10(10):14, https://doi.org/10.1167/tvst.10.10.14
Usage Policy:No commercial reproduction, distribution, display or performance rights in this work are provided.
ID Code:114279
Collection:CaltechAUTHORS
Deposited By: Tony Diaz
Deposited On:13 Apr 2022 17:11
Last Modified:13 Apr 2022 17:11

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