Ostad-Ahmadi Zakieh, Daemi Amin, Modabberi Mohammad-Reza, Mostafaie Ali
Department of Health Management, Policy and Economics, School of Management and Medical Informatics, Kerman University of Medical Sciences, Kerman 7616913555, Iran.
Health Management and Economics Research Center, Iran University of Medical Sciences, Tehran 1449614535, Iran.
Int J Ophthalmol. 2021 Feb 18;14(2):310-316. doi: 10.18240/ijo.2021.02.20. eCollection 2021.
To assess the effectiveness, safety, and cost-effectiveness of the Argus II in treatment of the retinitis pigmentosa (RP) patients.
The ProQuest, Web of Science, EMBASE, MEDLINE ( 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.
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.
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.
评估阿格斯二代（Argus II）治疗视网膜色素变性（RP）患者的有效性、安全性和成本效益。
通过组合使用阿格斯、安全性、有效性、仿生眼、视网膜假体和RP等关键词，检索截至2018年3月的ProQuest、科学网、EMBASE、医学期刊数据库（PubMed）。对检索到的记录进行筛选，然后评估其是否符合纳入标准。
从检索到的数据库中总共获取了926条记录，最终纳入12项研究。与植入假体前或假体停用时间相比，RP患者在接受假体植入后视觉功能有所改善。这通过方格定位、运动方向和光栅视力测试来衡量。未报告阿格斯二代假体本身和/或实施该假体的手术有重大不良反应，但最常报告的项目是低眼压和结膜裂开。在英国，增量成本效益比（ICER）计算为每质量调整生命年（QALY）14603欧元，在加拿大为每QALY 207616美元。
现有证据表明，阿格斯二代假体对RP患者改善视觉功能有效。该假体报告了一些轻微的不良反应。成本效益研究表明，该技术仅在支付意愿较高时才具有成本效益。
