gms | German Medical Science

Background: The Argus II retinal prosthesis is now commercially available. During the process of receiving approval for its distribution assessments of how the subjects functioned with the Argus II system were completed. In addition to data collection and scoring, evaluators wrote a case summary describing their impressions and offering their professional judgements on what they observed. This presentation will summarize these observations.

Methods: Functional Low-Vision Observer Rated Assessment FLORAs were completed on subjects in Europe and the United States during Phase III of the Argus II clinical trial. The FLORA is designed to allow customization by the assessor through the selection of items which the assessor believes will capture the functional abilities of the subject. The assessment protocol included an interview, evaluator ratings of observed behaviors, and a case summary. The purpose of the case summary was to allow the assessors to apply their expertise in rehabilitation to the experiences they had with the subject.

Results: 26 subjects were evaluated with the (FLORA). The case summaries provided 7 themes and 43 descriptions of behavior across the themes. A total of 279 descriptions were provided for the 26 subjects, an average of 10.5 per subject. Themes ranged from orientation abilities to social tasks and challenges using the system. Descriptions of behavior ranged from use of the system for activities of daily living, using the system for mobility tasks, and overall impact of system on daily life.

Conclusion: The FLORA demonstrates that useful information can be gathered with a systematic approach with the goal of increasing our understanding of how subjects utilize the Argus II in their daily life. Subjects showed increases in visual behavior as well as challenges with integrating new vision into their lifestyle.