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Frank Lane, Philip Troyk, Kristian Nitsch; Participants’ experiences in a clinical trial for vision restoration: Motivation to participate, visual perception and functional use, and experience of loss following termination. Invest. Ophthalmol. Vis. Sci. 2013;54(15):5317.
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At the 2012 World Congress on Artificial Vision, more than 12 investigators reported on the status of their vision implant designed to restore visual percepts for people who are blind. Many of the investigations have moved to human clinical trials, yet, to date little exists in the literature on the experiences of participants in visual prosthesis trials. This presentation is the first report on the experiences of 12 of the 16 recipients implanted with a surface-cortex implant by William Dobelle.
In-depth qualitative interviews of individuals who received a Dobelle cortical visual prosthesis were conducted. Eleven recipients, and the parents of one deceased recipient, were contacted and invited to an interview, so that they could describe their experiences of participation in the Dobelle study. Informed consent was obtained from all participants. All interviews were audio or video recorded, professionally transcribed, and qualitatively analyzed using MAXQDA software.
Analyses of participant interviews revealed motivation that has not been previously documented. While restoration of vision emerged as the strongest motivator, altruism, excitement associated with participating in “ground breaking” research, and the importance of hope were notable; these have not been reported in the literature and are not well understood. While some of the recipients reported no functional benefit from the implant, others described perceiving a range of phosphenes with as few as two and as many as 119. Participants describe functional benefits across this range of phosphenes. Individuals who experienced restored visual perception also experienced feelings of loss upon project termination.
The experiences of former implantable device users should be a critical component of every implantable device project, especially when considering the risk/benefit ratio. The Dobelle recipients interviewed in this study have provided valuable information on the importance of including self-reported feedback from participants in clinical trials. These interview results are being used to develop a framework to prepare for the screening and informed consent of future visual prosthesis human implantation trials.
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