# Early Feasibility Clinical Trial of a Visual Cortical Prosthesis

> **NIH NIH UH3** · SECOND SIGHT MEDICAL PRODUCTS, INC. · 2021 · $155,964

## Abstract

PROJECT SUMMARY
 Blindness in the United States is a large and increasing problem. Any significant vision loss is debilitating,
but profound blindness is devastating to an individual’s ability to be independent and to perform everyday tasks
and activities. Hundreds of thousands of people in the United States suffer from profound blindness.
 The goal of this project is to conduct a small scale clinical study with the intent of developing the final
version of a visual prosthesis to be placed in the visual cortex – the part of the brain that processes vision. It is
based on the successful platform of the Argus II System (a retinal visual prosthesis), but modified for implant in
the brain. A cortical prosthesis could help restore visual perception to many more profoundly blind people,
including people who have lost their vision due to disease or damage to the eyes, optic nerve, or thalamus. The
parent project aims to evaluate safety, efficacy, reliability, and to conduct psychophysics characterization
studies. The goal is that by the end of the grant period, the cortical prosthesis will be completely developed and
positioned for testing in a larger group of human subjects.
 In addition to the above goals, it is increasingly evident that the success of such neurotechnology
development also depends on critically understanding the relative valuation of risks and benefits from the
perspective of the target population. These perspectives are increasingly recognized as recurring and critical in
the development and adoption of new neurotechnologies. This supplement proposal in response to NOT-OD-
21-020 is a bioethics research proposal that aims to gain insight into perspectives of blind patients on
acceptable risks, necessary benefits, and appropriate risk/benefit balance for visual cortical prostheses, with the
aim of guiding the development of devices in line with the target population’s values. Without the input from
the target population, we may be inappropriately determining the acceptable risk/benefit profile for visual
cortical prostheses. Building on ongoing investigation of perspectives of current Orion trial participants, the
work proposed here will interview 15 blind patient who would be eligible for Orion but have not yet been
implanted, using semi-structured interviews. The knowledge gleaned will inform further development of the
device, guide future psychophysical experiments, and promote regulatory approval of future trials of visual
cortical prostheses in line with the target population’s perspectives and values, increasing the likelihood that
the parent project to exert an influence and deliver a novel therapeutic technology.

## Key facts

- **NIH application ID:** 10365847
- **Project number:** 3UH3NS103442-03S1
- **Recipient organization:** SECOND SIGHT MEDICAL PRODUCTS, INC.
- **Principal Investigator:** Jessy D Dorn
- **Activity code:** UH3 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2021
- **Award amount:** $155,964
- **Award type:** 3
- **Project period:** 2018-09-15 → 2024-03-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10365847

## Citation

> US National Institutes of Health, RePORTER application 10365847, Early Feasibility Clinical Trial of a Visual Cortical Prosthesis (3UH3NS103442-03S1). Retrieved via AI Analytics 2026-05-27 from https://api.ai-analytics.org/grant/nih/10365847. Licensed CC0.

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