Safety, effectiveness, and cost-effectiveness of Argus II in patients with retinitis pigmentosa: a systematic review.

AIM: To assess the effectiveness, safety, and cost-effectiveness of the Argus II in treatment of the retinitis pigmentosa (RP) patients.

METHODS

The ProQuest, Web of Science, EMBASE, MEDLINE (via PubMed) were searched using combinations of the keywords of Argus, safety, effectiveness, bionic eye, retinal prosthesis, and RP through March 2018. The retrieved records were screened and then assessed for eligibility.

RESULTS

Totally 926 records were retrieved from the searched databases and finally 12 studies included. The RP patients showed improvements in visual function after receiving the prosthesis, compared to the time before the prosthesis or the time it was off. This was measured by square localization, direction of motion, and grating visual acuity tests. No major adverse effect was reported for the Argus II prosthesis itself and/or the surgery to implement it, but the most frequently reported items were hypotony, and conjunctival dehiscence. The incremental cost-effectiveness ratio (ICER) was calculated to be €14603 per quality-adjusted life year (QALY) in UK and $207 616 per QALY in Canada.

CONCLUSION

The available evidence shows that the Argus II prosthesis in RP patients is effective in improvement of their visual function. Some minor adverse effects are reported for the prosthesis. The cost-effectiveness studies show that the technology is cost-effective only at high levels of willingness-to-pay.