Purpose: Retinitis pigmentosa (RP) is a hereditary disease causing photoreceptor degeneration and permanent vision loss. Retinal implantation of a stimulating electrode array is a new treatment for RP, but quantification of its efficacy is the subject of ongoing work. This review evaluates vision-related outcomes resulting from retinal implantation in participants with RP.
Methods: We searched MEDLINE and Embase for journal articles published since January 1, 2015. We selected articles describing studies of implanted participants that reported the postimplantation measurement of vision. We extracted study information including design, participants' residual vision, comparators, and assessed outcomes. To assess the risk of bias, we used signaling questions and a target trial.
Results: Our search returned 425 abstracts. We reviewed the full text of 34 articles. We judged all studies to be at high risk of bias owing to the study design or experimental conduct. Regarding design, studies lacked the measures that typical clinical trials take to protect against bias (e.g., control groups and masking). Regarding experimental conduct, outcome measures were rarely comparable before and after implantation, and psychophysical methods were prone to bias (subjective, not forced choice, methods). The most common comparison found was between postimplantation visual function with the device powered off versus on. This comparison is at high risk of bias.
Conclusions: There is a need for high-quality evidence of efficacy of retinal implantation to treat RP.
Translational relevance: For patients and clinicians to make informed choices about RP treatment, visual function restored by retinal implantation must be properly quantified and reported.