Functional vision in the real-world environment with a second-generation (44-channel) suprachoroidal retinal prosthesis
Open accessAbstract
Purpose: In a clinical trial (NCT03406416) of a second-generation (44-channel) suprachoroidal retinal prosthesis implanted in subjects with late-stage retinitis pigmentosa (RP), we assessed performance in real-world functional visual tasks and emotional well-being. Methods: The Functional Low-Vision Observer Rated Assessment (FLORA) and Impact of Vision Impairment-Very Low Vision (IVI-VLV) instruments were administered to four subjects before implantation and after device fitting. The FLORA contains 13 self-reported and 35 observer-reported items ranked for ease of conducting task (impossible-easy, central tendency given as mode). The IVI-VLV instrument quantified the impact of low vision on daily activities and emotional well-being. Results: Three subjects completed the FLORA for two years after device fitting; the fourth subject ceased participation in the FLORA after fitting for reasons unrelated to the device. For all subjects at each post-fitting visit, the mode ease of task with device ON was better or equal to device OFF. Ease of task improved over the first six months with device ON, then remained stable. Subjects reported improvements in mobility, functional vision, and quality of life with device ON. The IVI-VLV suggested self-assessed vision-related quality of life was not impacted by device implantation or usage. Conclusions: Subjects demonstrated sustained improved ease of task scores with device ON compared to OFF, indicating the device has a positive impact in the real-world setting. Translational Relevance: Our suprachoroidal retinal prosthesis shows potential utility in everyday life, by enabling an increased environmental awareness and improving access to sensory information for people with end-stage RP.
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Existing visual prostheses generally provide an improved ability to localize high-contrast objects and to perform basic orientation and mobility tasks.
“Existing devices generally provide an improved ability to localize high-contrast objects and to perform basic orientation & mobility tasks (Geruschat et al., 2012; Karapanos et al., 2021).”
From Towards a <i>Smart Bionic Eye</i> : AI-powered artificial vision for the treatment of incurable blindness (2022) · cites this paper as Karapanos et al., 2021
The Results (FLORA–Ease of Task Scores) report improved ability to find doorways and locate objects, and the Discussion says the device improved day-to-day orientation and mobility outcomes. But the paper studies one prosthesis, not existing devices generally; its own visual-mobility tasks showed minimal improvement, and it does not establish a general improvement in localizing high-contrast objects. (LLM, conf=0.84)
Experimental — accuracy not yet measuredIn practice, FLORA is often employed as an external validation tool that constitutes the very last step of the design process.
“While it is encouraging to see increasing adoption of FLORA by the community (Geruschat et al., 2016; Karapanos et al., 2021), in practice it is often employed as an external validation tool that constitutes the very last step of the design process—a proof of concept, so to speak.”
From Towards a <i>Smart Bionic Eye</i> : AI-powered artificial vision for the treatment of incurable blindness (2022) · cites this paper as Karapanos et al., 2021
The Methods passage and Figure 1 timeline show FLORA used to assess the prosthesis, including an independent specialist’s assessments before implantation and at multiple points after device fitting. This supports its use as an evaluation tool, but not the claim that it is often an external validation tool used only at the very last step of design. (LLM, conf=0.84)
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References 32 · Cited by 30
- Authors
- Karapanos, L., Abbott, C. J., Ayton, L. N., Kolic, M., McGuinness, M. B., Baglin, E. K., Titchener, S. A., Kvansakul, J., Johnson, D., Kentler, W. G., Barnes, N., Nayagam, D. A. X., Allen, P. J., & Petoe, M. A.
- Affiliations
- The University of Melbourne (AU)
- The Royal Victorian Eye & Ear Hospital (AU)
- Bionics Institute (AU)
- Specialised Orientation and Mobility, Melbourne, VIC, Australia
- Australian National University (AU)
- Corresponding author
- Petoe, Matthew A.
- ORCID
- Venue
- Translational Vision Science & Technology
- Published
- 2021-08-12
- Volume
- 10
- Issue
- 10
- Pages
- 7
- ISSN
- 2164-2591 (ISSN-L)
- PMC
- PMC8362639
- OpenAlex
- W3188148682
- Cited by
- 30
- References
- 32
- Citations by year
- 2026: 7 · 2025: 7 · 2024: 5 · 2023: 6 · 2022: 5
- FWCI
- 1.84
- Type
- journal article
- Language
- en
- Open access
- gold
- doi.org
- Licence
- Locations
- Translational Vision Science & Technology (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
- 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, functional vision, flora, quality of life, emotional well-being, mobility (physical function), environmental awareness
- MeSH terms
- Humans, Quality of Life, Retinitis Pigmentosa, Vision, Ocular, Vision, Low, Visual Prosthesis
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