A Second-Generation (44-Channel) Suprachoroidal Retinal Prosthesis: Interim Clinical Trial Results
Open accessAbstract
Purpose: To report the initial safety and efficacy results of a second-generation (44-channel) suprachoroidal retinal prosthesis at 56 weeks after device activation. Methods: Four subjects, with advanced retinitis pigmentosa and bare-light perception only, enrolled in a phase II trial (NCT03406416). A 44-channel electrode array was implanted in a suprachoroidal pocket. Device stability, efficacy, and adverse events were investigated at 12-week intervals. Results: All four subjects were implanted successfully and there were no device-related serious adverse events. Color fundus photography indicated a mild postoperative subretinal hemorrhage in two recipients, which cleared spontaneously within 2 weeks. Optical coherence tomography confirmed device stability and position under the macula. Screen-based localization accuracy was significantly better for all subjects with device on versus device off. Two subjects were significantly better with the device on in a motion discrimination task at 7, 15, and 30°/s and in a spatial discrimination task at 0.033 cycles per degree. All subjects were more accurate with the device on than device off at walking toward a target on a modified door task, localizing and touching tabletop objects, and detecting obstacles in an obstacle avoidance task. A positive effect of the implant on subjects' daily lives was confirmed by an orientation and mobility assessor and subject self-report. Conclusions: These interim study data demonstrate that the suprachoroidal prosthesis is safe and provides significant improvements in functional vision, activities of daily living, and observer-rated quality of life. Translational Relevance: A suprachoroidal prosthesis can provide clinically useful artificial vision while maintaining a safe surgical profile.
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Studies on suprachoroidal devices have generally assessed patient autonomy, mobility, and object discrimination, rather than visual acuity.
“In comparison, studies on suprachoroidal devices25,36 have generally assessed patient autonomy, mobility, and object discrimination, rather than visual acuity.”
From Visual Prostheses in the Era of Artificial Intelligence Technology (2025) · cites this paper as [25]
The Methods sections on Tabletop Search and FLORA assess object identification, daily activities, and mobility, supporting the description of this trial’s emphasis. But the Methods and Results sections on Screen-based Assessments also report a Basic Grating Acuity test, so visual acuity was not wholly set aside. This single trial also does not establish what suprachoroidal-device studies have generally assessed; the indexed passages provide no page numbers. (LLM, conf=0.84)
Experimental — accuracy not yet measuredThe SRP has demonstrated better clinical outcomes than other retinal prostheses, possibly due to the larger size of the implant.
“So far, the SRP has demonstrated better clinical outcomes, possibly due to the larger size of the implant, which delivers a broad view compared to other retinal prostheses.”
From Visual Prostheses in the Era of Artificial Intelligence Technology (2025) · cites this paper as [25]
The Discussion (page unavailable in our copy) says the device’s modified-door-task and tabletop results compare favorably with results reported for other retinal prostheses. It also says the electrodes span a larger retinal area than those of the Argus II or Alpha AMS. It does not attribute the favorable outcomes to implant size, and its comparisons do not establish better clinical outcomes overall. (LLM, conf=0.88)
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References 63 · Cited by 63
- Authors
- Petoe, M. A., Titchener, S. A., Kolic, M., Kentler, W. G., Abbott, C. J., Nayagam, D. A. X., Baglin, E. K., Kvansakul, J., Barnes, N., Walker, J. G., Epp, S. B., Young, K. A., Ayton, L. N., Luu, C. D., Allen, P. J., & for the Bionics Institute and Centre for Eye Research Australia Retinal Prosthesis Consortium
- Affiliations
- Bionics Institute (AU)
- The Royal Victorian Eye & Ear Hospital (AU)
- The University of Melbourne (AU)
- Australian National University (AU)
- Corresponding author
- Allen, Penelope J.
- ORCID
- Venue
- Translational Vision Science & Technology
- Published
- 2021-09-28
- Volume
- 10
- Issue
- 10
- Pages
- 12
- ISSN
- 2164-2591 (ISSN-L)
- PMC
- PMC8479573
- OpenAlex
- W3203336689
- Cited by
- 63
- References
- 63
- Citations by year
- 2026: 11 · 2025: 16 · 2024: 12 · 2023: 15 · 2022: 9
- FWCI
- 4.15
- Type
- journal article
- Language
- en
- Open access
- gold
- doi.org
- Licence
- Locations
- Translational Vision Science & Technology (publishedVersion, cc-by-nc-nd)
- Europe PMC (PubMed Central) (publishedVersion, cc-by-nc-nd)
- PubMed Central (publishedVersion, cc-by-nc-nd)
- PubMed (publishedVersion)
- ANU Open Research (Australian National University) (submittedVersion, cc-by-nc-nd)
- Minerva Access (University of Melbourne) (submittedVersion, cc-by-nc-nd)
- Funders
- State Government of Victoria
- Medical Research Council
- National Health and Medical Research Council (1082358)
- Topics
- Life Sciences › Neuroscience › Cellular and Molecular Neuroscience › Neuroscience and Neural Engineering
- Life Sciences › Biochemistry, Genetics and Molecular Biology › Molecular Biology › Retinal Development and Disorders
- Health Sciences › Medicine › Ophthalmology › Retinal Diseases and Treatments
- Keywords
- retinitis pigmentosa, artificial vision, device stability, motion discrimination, spatial discrimination, obstacle avoidance, orientation and mobility, activities of daily living, quality of life, subretinal hemorrhage
- MeSH terms
- Activities of Daily Living, Humans, Quality of Life, Retinitis Pigmentosa, Vision, Ocular, Visual Prosthesis
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