Perspectives of optic nerve prostheses

Abstract

A number of projects exist that are investigating the ability to restore visual percepts for individuals who are blind through a visual prosthesis. While many projects have reported the results from a technical basis, very little exists in the professional literature on the human experience of visual implant technology. The current study uses an ethnographic methodological approach to document the experiences of the research participants and study personnel of a optic nerve vision prosthesis project in Brussels, Belgium. The findings have implications for motivation for participating in clinical trials, ethical safeguards of participants and the role of the participant in a research study. Implications for Rehabilitation Rehabilitation practitioners are often solicited by prospective participants to assist in evaluating a clinical trial before making a decision about participation. Rehabilitation professionals should be aware that: The decision to participate in a clinical trial is ultimately up to the individual participant. However, participants should be aware that family members might experience stress from of a lack of knowledge about the research study. The more opportunities a participant has to share thoughts and feelings about the research study with investigators will likely result in a positive overall experience. Ethical safeguards put in place to protect the interests of an individual participant may have the opposite effect and create stress. Rehabilitation professionals can play an important role as participant advocates from recruitment through termination of the research study. Participant hope is an important component of participation in a research study. Information provided to participants by investigators during the consent process should be balanced carefully with potential benefits, so it does not destroy a participant's hope.

Harmonization of Outcomes and Vision Endpoints in Vision Restoration Trials: Recommendations from the International HOVER Taskforce

“…A composite self-image of being a pioneer, being first, exploring the unknown, or even achieving a sciencefiction-like persona may attract some to experimentation. Kilgore and colleagues 164 reported this influence for recipients of spinal cord implants, and Lane et al [158][159][160] found similar trends for recipients of visual prostheses. A danger of relying upon adventurism as a qualifying motivation for trial participation is that risks, most of which are known to the researchers and, it is hoped, conveyed appropriately to potential participants, can be too easily dismissed by accepting the principles of autonomy and self-determination as overriding compensations.…”

“…Too often forms and protocols developed for the informed consent process appear to provide more protection to the sponsoring institution than to the volunteer. 157,158…”

“…Soliciting user viewpoints about the function and form of a developing visual prosthesis can provide unexpected and significant guidelines for the development of the native technology and can avoid unexpected disappointments in the later stages of system deployment. 158 – 160 For example, prospective participants who participated in a series of focus groups and individuals who received a specific device stated that the cosmetics of the device was a factor that would determine whether or not they would consent to participate in a visual prosthetic clinical trial. 160 This perspective from prospective users, which modified future considerations in design development, was not fully appreciated or anticipated by the technical development team.…”

Visual Prosthesis: Interfacing Stimulating Electrodes with Retinal Neurons to Restore Vision

“…Images are typically processed by an externally-worn computer which instructs the implanted system to deliver electrical impulses via implanted electrodes (Brandli et al, 2016 ). Various stimulation sites have been considered: the visual cortex (Lewis and Rosenfeld, 2016 ), the optic nerve (Lane et al, 2016 ), the lateral geniculate nucleus (Nguyen et al, 2016 ) and the retina (da Cruz et al, 2016 ).…”

Psychosocial assessment of potential retinal prosthesis trial participants

“…Research conducted by Lane et al identified a number of key personality traits that relate to motivation to participate in a visual prosthesis clinical trial, including altruism, adventurism, and advanced decision‐making skills . While these are undoubtedly useful considerations when screening for potential implant recipients, this current understanding is limited to findings from focus groups and interviews.…”