In an ageing population, efficiency improvements are required to assure future accessibility of cataract care. We aim to address remaining knowledge gaps by evaluating the safety, effectiveness, and cost-effectiveness of immediate sequential bilateral cataract surgery (ISBCS) versus delayed sequential bilateral cataract surgery (DSBCS). We hypothesised that ISBCS is non-inferior to DSBCS, regarding safety and effectiveness, and being superior in cost-effectiveness. We did a multicentre, non-inferiority, randomised controlled trial, which included participants from ten Dutch hospitals. Eligible participants were 18 years or older, underwent expected uncomplicated surgery, and had no increased risk of endophthalmitis or refractive surprise. Participants were randomly assigned (1:1) to either the ISBCS (intervention) group or DSBCS (conventional procedure) group, using a web-based system stratified by centre and axial length. Participants and outcome assessors were not masked to the treatment groups because of the nature of the intervention. The primary outcome was the proportion of second eyes with a target refractive outcome of 1·0 dioptre (D) or less 4 weeks postoperatively, with a non-inferiority margin of –5% for ISBCS versus DSBCS. For the trial-based economic evaluation, the primary endpoint was the incremental societal costs per quality-adjusted life-year. All analyses were done by a modified intention-to-treat principle. Costs were calculated by multiplying volumes of resource use with unit cost prices and converted to 2020 Euros (€) and US$. This study was registered with ClinicalTrials.gov, number , and is now closed for recruitment. Between Sept 4, 2018, and July 10, 2020, a total of 865 patients were randomly assigned to either the ISBCS group (427 [49%] patients; 854 eyes) or DSBCS group (438 [51%] patients; 876 eyes). In the modified intention-to-treat analysis, the proportion of second eyes with a target refraction of 1·0 D or less was 97% (404 of 417 patients) in the ISBCS group versus 98% (407 of 417) in the DSBCS group. The percentage difference was –1% (90% CI –3 to 1; p=0·526), thereby establishing non-inferiority for ISBCS compared with DSBCS. Endophthalmitis was not observed or reported in either group. Adverse events were comparable between groups, with only a significant difference in disturbing anisometropia (p=0·0001). Societal costs were €403 (US$507) lower with ISBCS than with DSBCS. The cost-effectiveness probability of ISBCS versus DSBCS was 100% across the willingness-to-pay range of €2500–80 000 (US$3145–100 629) per quality-adjusted life-year. Our results showed non-inferiority of ISBCS versus DSBCS regarding effectiveness outcomes, comparable safety, and superior cost-effectiveness of ISBCS. National cost savings could amount to €27·4 million (US$34·5 million) annually, advocating for ISBCS if strict inclusion criteria are applied. Research grant from The Netherlands Organization for Health Research and Development (ZonMw) and Dutch Ophthalmological Society.

中文翻译：

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荷兰立即与延迟序贯双侧白内障手术的安全性、有效性和成本效益（BICAT-NL 研究）：一项多中心、非劣效性、随机对照试验

在人口老龄化的背景下，需要提高效率以确保未来白内障护理的可及性。我们的目标是通过评估即刻序贯双侧白内障手术 (ISBCS) 与延迟序贯双侧白内障手术 (DSBCS) 的安全性、有效性和成本效益来解决剩余的知识差距。我们假设 ISBCS 在安全性和有效性方面不逊色于 DSBCS，并且在成本效益方面更胜一筹。我们进行了一项多中心、非劣效性、随机对照试验，其中包括来自十家荷兰医院的参与者。符合资格的参与者年满 18 岁，接受了预期的简单手术，并且眼内炎或屈光异常的风险没有增加。使用按中心和轴长分层的基于网络的系统，将参与者随机分配 (1:1) 到 IBCS（干预）组或 DSBCS（传统手术）组。由于干预的性质，参与者和结果评估者不会对治疗组隐藏。主要结果是术后 4 周第二只眼的目标屈光结果为 1·0 屈光度 (D) 或更低的比例，ISBCS 与 DSBCS 的非劣效界值为 –5%。对于基于试验的经济评估，主要终点是每个质量调整生命年的增量社会成本。所有分析均按照修改后的意向治疗原则进行。成本的计算方法是将资源使用量乘以单位成本价格，并转换为 2020 年欧元 (€) 和美元。该研究已在 ClinicalTrials.gov 注册，编号为 ，现已停止招募。2018年9月4日至2020年7月10日期间，共有865名患者被随机分配至ISBCS组（427名患者[49%]；854只眼）或DSBCS组（438名[51%]名患者；876只眼） 。在改良的意向治疗分析中，ISBCS 组第二眼目标屈光度为 1·0 D 或更低的比例为 97%（417 名患者中的 404 名），而 DSBCS 组中为 98%（417 名患者中的 407 名）团体。百分比差异为 –1%（90% CI –3 至 1；p=0·526），从而确定 IBCS 与 DSBCS 相比具有非劣效性。两组均未观察到或报告眼内炎。各组之间的不良事件具有可比性，仅在令人不安的屈光参差方面存在显着差异（p=0·0001）。IBCS 的社会成本比 DSBCS 低 403 欧元（507 美元）。在每质量调整生命年 2500-80 000 欧元（3145-100 629 美元）的支付意愿范围内，ISBCS 与 DSBCS 的成本效益概率为 100%。我们的结果表明，在 IBCS 的有效性结果、可比较的安全性和卓越的成本效益方面，ISBCS 与 DSBCS 相比并不逊色。如果应用严格的纳入标准，提倡 IBCS，每年可节省国家成本 27·400 万欧元（34·500 万美元）。