Department of Ophthalmology (Qvision), VITHAS Hospital, Almería, Spain.
Department of Optics, Pharmacology and Anatomy, University of Alicante, Alicante, Spain.
Eye (Lond). 2023 Mar;37(4):587-596. doi: 10.1038/s41433-022-02175-3. Epub 2022 Jul 21.
The aim of this study was to collect the scientific literature on the correction of presbyopia with laser in situ keratomileusis (presbyLASIK) in last years and to analyse the quality of such scientific evidence using a validated methodology for conducting a systematic review. A total of 42 articles were initially identified, but after applying the selection criteria and an additional manual search a total of 23 articles were finally included: 2 non-randomized controlled clinical trials (NRCT) and 21 case series. Quality assessment of NRCTs and case series was performed with the ROBINS-I and the 20-criterion quality appraisal checklist defined by Moga et al. (IHE Publ 2012), respectively. For NRCT, the risk of bias was moderate in one study and serious in the other NRCT, being the main sources of risk, the domains related to confounding, selection of participants and measurement of outcomes. For case series studies, the main source of risk of bias was subjects not entering the study at the same point of the conditions (different levels of presbyopia). Likewise, a significant level of uncertainty was detected for the following items: consecutive recruitment of patients, blinding of outcome assessors to the intervention that the patient received, and conclusions of the study not supported by the results. Research on presbyLASIK to this date is mainly focused on case series generating a limited level of scientific evidence. The two NRCTs identified only demonstrated the potential benefit of combining the multiaspheric profile with some level of monovision in the non-dominant eye.
本研究旨在收集近年来应用准分子激光原位角膜磨镶术(presbyLASIK)矫正老视的科学文献,并使用经过验证的系统评价方法分析此类科学证据的质量。最初共确定了 42 篇文章,但在应用选择标准和额外的手动搜索后,最终共纳入 23 篇文章:2 项非随机对照临床试验(NRCT)和 21 项病例系列研究。使用 ROBINS-I 和 Moga 等人定义的 20 项质量评估检查表(IHE Publ 2012)分别对 NRCT 和病例系列研究进行质量评估。对于 NRCT,一项研究的偏倚风险为中度,另一项 NRCT 的偏倚风险为严重,偏倚的主要来源是与混杂、参与者选择和结果测量相关的领域。对于病例系列研究,偏倚风险的主要来源是受试者在同一条件下(不同程度的老视)未进入研究。同样,对以下项目也检测到了显著的不确定性水平:患者连续招募、结局评估者对患者接受的干预措施保持盲法,以及研究结论与结果不一致。迄今为止,关于 presbyLASIK 的研究主要集中在生成科学证据水平有限的病例系列研究上。确定的两项 NRCT 仅证明了在非主导眼联合多球镜和一定程度的单视的潜在益处。