Disentangling Function from Benefit: Participant Perspectives from an Early Feasibility Trial for a Novel Visual Cortical Prosthesis

Abstract

Visual cortical prostheses (VCPs) have the potential to provide artificial vision for visually impaired persons. However, the nature and utility of this form of vision is not yet fully understood. Participants in the early feasibility trial for the Orion VCP were interviewed to gain insight into their experiences using artificial vision, their motivations for participation, as well as their expectations and assessments of risks and benefits. Analyzed using principles of grounded theory and an interpretive description approach, these interviews yielded six themes, including: the irreducibility of benefit to device functionality, mixed expectations for short-term device functionality and long-term technological advancement of visual prostheses, and a broad range of risks, concerns, and fears related to trial participation. We argue that these narratives motivate a nuanced set of ethical considerations related to the complex relationship between functionality and benefit, the intersection of user experience with disability justice, and the import of expectations and indirect risks on consent.

Keywords:

• Critical disability studies
• emerging neurotechnology
• neuroethics
• participant perspectives
• research ethics
• visual prostheses

This article is referred to by:

Experience, Embodiment, and Post-Trial Obligations in Brain-Based Visual Prosthesis Research

Neglected Stakeholder Perspectives in Qualitative Neural Implant Research

Disability Justice, Interdependence, and the Development of Assistive Visual Devices

Benefits vs. Risks: Neural Device Maintenance and Potential Abandonment

How Blind Persons Perceive Sight-Restorative Technologies Matters More than We Know

DISCLOSURE STATEMENT

Ashley Feinsinger is the patient advocate on the independent safety monitoring committee for the Orion trial, a role she assumed after the data collection, interviewing, and analysis for this study had already been completed. Nader Pouratian is a consultant for Abbott Laboratories and Sensoria Therapeutics, is a speaker for BrainLab, and is a PI on UH3NS103442 with Second Sight Medical Products supporting the early feasibility study for Orion visual cortical prosthesis. He did not participate in the recruitment, consent, interviewing, or interview analysis for this paper. The maker of the device, Second Sight Medical Products (now Vivani Medical), did not influence the collection or interpretation of the data or any part of the preparation of the manuscript.

Notes

1 Notably Dobelle obtained neither funding nor approval to implant devices in the United States so his participants flew to Portugal for the procedure and paid their own way. His experiments were abruptly halted after his unexpected death in 2004.

2 The location of the implant has advantages and disadvantages for different sets of users. Retinal implants are only indicated for people who have lost vision due to specific diseases like retinitis pigmentosa and age-related macular degeneration, whereas cortical implants bypass the anatomy of the eye entirely and may be used in individuals with a wider range of causes of acquired blindness.

Additional information

Funding

This research was funded by an NIH supplemental ethics grant to “Early Feasibility Clinical Trial of a Visual Cortical Prosthesis”, UH3NS103442, as well as RF1MH121373.