title: Emotional wellbeing of blind patients in a pilot trial with subretinal implants.
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.
  
  
  CONCLUSIONS
  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.
authors.affiliation: STZ eyetrial at the Centre for Ophthalmology, University Eye Hospital, Schleichstrasse 12-16, 72076, Tuebingen, Germany. tobias.peters@stz-biomed.de
authors.forename: Tobias
authors.initials: T
authors.lastname: Peters
authors.forename: Stefan
authors.initials: S
authors.lastname: Klingberg
authors.forename: Eberhart
authors.initials: E
authors.lastname: Zrenner
authors.forename: Barbara
authors.initials: B
authors.lastname: Wilhelm
mesh_terms: D000328:Adult; D001766:Blindness / Q000523:psychology* / Q000601:surgery; D004644:Emotions; D006304:Health Status; D006801:Humans; D008297:Male; D008603:Mental Health; D008875:Middle Aged; D019919:Prosthesis Implantation; D012174:Retinitis Pigmentosa / Q000523:psychology* / Q000601:surgery; D012720:Severity of Illness Index; D013315:Stress, Psychological; D011795:Surveys and Questionnaires; D014792:Visual Acuity / Q000502:physiology; D057488:Visual Prosthesis