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Jessy D. Dorn, Duane Geruschat, Gislin Dagnelie, Robert J. Greenberg, FLORA Working Group, Argus II Study Group; Functional vision and quality of life of Argus® II Retinal Prosthesis System users as measured by the Functional Low-vision Observer Rated Assessment (FLORA). Invest. Ophthalmol. Vis. Sci. 2012;53(14):5511.
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As visual prostheses and other vision restoration treatments become commercially available, there is a need for tools to assess the impact of treatments on patients’ functional vision and quality of life. There are few standardized assessments suitable for the severely visually impaired populations served by these new treatments.To fill this need, we developed the Functional Low-vision Observer Rated Assessment (FLORA) in a collaboration between Second Sight Medical Products, Certified Orientation and Mobility Specialists, and Certified Occupational Therapists/Low Vision Therapists. The FLORA was then used to measure the impact of the Argus II Retinal Prosthesis System on 26 subjects worldwide.
The FLORA is a subjective assessment intended to be performed by trained low-vision rehabilitation specialists. It comprises three parts: an in-depth interview with the prosthesis subject, observer-rated functional vision tasks performed with the Argus II System ON and OFF, and a final case report that summarizes the assessor’s conclusions about the impact of the system on the subject’s life.Twenty-six Argus II subjects were evaluated with the FLORA; they had been implanted between 17 and 44 months at the time of the assessment. The final case reports were evaluated by an independent observer who rated the effect of the system on each patient on the following scale: positive effect, mild positive effect, prior positive effect, neutral effect, or negative effect.
Of the 30 subjects enrolled in the clinical trial, 9 (30%) were rated as having received a positive effect of the system, 7 (23.3%) as mild positive effect, 4 (13.3%) as prior positive effect, 6 (20%) as neutral effect, and 0 as negative effect. The remaining 4 subjects (13.3%) did not participate in the FLORA; one had previously been explanted, and three declined to participate.
The FLORA is a new tool suitable for assessing the functional vision and quality of life effects of vision restoration treatments on blind patients. When applied to 30 Argus II clinical trial subjects, it revealed that 66.7% of subjects had experienced some positive effect of the retinal prosthesis, as judged by independent low-vision rehabilitation experts.
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