Abstract
Background
Participation in first human applications of retinal neuroprosthesis may create psychological stress for blind retinitis pigmentosa patients. The aim of this study was to assess the emotional wellbeing of patients undergoing implantation of a subretinal implant.
Methods
Nine blind patients participating in a pilot trial with subretinal implants were enlisted. The Brief Symptom Inventory (BSI), a short self-report scale of nine primary symptoms, was used to assess reaction to the psychological distress related to study participation. The number and the intensity of symptoms were analysed, and global scores for overall psychological distress (tGSI), severity of reported symptoms (tPDSI), and level number of self-reported symptoms (tPST) were calculated. The questionnaire was administered before implantation, 2–3 times during the trial and before explantation.
Results
There were no significant alterations during the trial for the average scores of the nine primary symptoms. One patient, however, showed values higher than the norm, for six subscores before implantation and for eight subscores before explantation. A significant improvement was found in both the overall psychological distress level (tGSI) and the severity of reported symptoms (tPDSI) at the final visit, compared to those at the study start. The number of self-reported symptoms (tPST) was not significantly altered.
Conclusion
In the first ongoing pilot trial with an active, cable-bound subretinal implant, we found that trial participation and the implant procedure and subsequent testing did not have any adverse effects on the participants’ emotional wellbeing. Their distress generally improved during study participation, rather than showing signs of decreased wellbeing.
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Acknowledgments
We thank the following people for their support in this trial: H. Oelman, C. Kuttenkeuler, R. Wilke and T. Zabel. The authors also thank Anne Kurtenbach for her help in preparing this manuscript. The study was supported by the German Federal Ministry of Education and Research (BMBF: 01KP0401) and the Retinal Implant GmBH, Reutlingen, Germany
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Peters, T., Klingberg, S., Zrenner, E. et al. Emotional wellbeing of blind patients in a pilot trial with subretinal implants. Graefes Arch Clin Exp Ophthalmol 251, 1489–1493 (2013). https://doi.org/10.1007/s00417-012-2210-6
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DOI: https://doi.org/10.1007/s00417-012-2210-6