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Cost-effectiveness of immediate versus delayed sequential bilateral cataract surgery in the Netherlands (the BICAT-NL study): study design of a prospective multicenter randomised controlled trial

机译:荷兰直接与延迟顺序双侧白内障手术的成本效益(Bicat-NL研究):研究设计设计对潜在的多中心随机对照试验

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Cataract surgery is one of the most frequently performed types of surgery. Most patients suffer from bilateral cataract and while cataract surgery of only one eye is effective in restoring functional vision, second-eye surgery leads to further improvements in health-related quality of life, and is cost-effective. At present, most patients undergo cataract surgery in both eyes on separate days as recommended in national guidelines, referred to as delayed sequential bilateral cataract surgery (DSBCS). An alternative procedure involves operating both eyes on the same day, but as separate procedures, known as immediately sequential bilateral cataract surgery (ISBCS). The aim of this study is to evaluate the effectiveness and costs of ISBCS compared to DSBCS, in order to test the hypothesis that ISBCS is non-inferior to DSBCS in terms of effectiveness and superior to ISBCS in terms of cost-effectiveness. Multicenter non-inferiority randomised controlled clinical trial. Patients (18?years or older) with bilateral cataract and an indication for bilateral cataract surgery with an expected uncomplicated intraoperative and postoperative course are included in the study. Patients are randomly assigned to either ISBCS or DSBCS. The primary endpoint is the proportion of patients with a refractive outcome in the second eye within 1.0 dioptre from the target refraction, at 4 weeks after surgery. Secondary outcomes include corrected and uncorrected distance visual acuity, complications, patient reported outcomes (PROMs), cost-effectiveness, and budget impact. Follow-up visits are planned at 1 week after first-eye surgery and 4 weeks after second-eye surgery. At 3 months after first-eye surgery, the occurrence of complications is checked and patients fill in a final questionnaire. This study protocol describes the design of a multicenter non-inferiority randomised controlled trial. Current studies on ISBCS often lack information on safety regarding refractive outcomes. In addition, there is a lack of well-designed cost-effectiveness studies using established methods. The BICAT-NL study will provide more insight in refractive and cost-effectiveness outcomes for ISBCS compared to DSBCS. This study was prospectively registered at Clinicaltrials.gov on January 17th 2018. (Identifier: NCT03400124 .
机译:白内障手术是最常见的手术类型之一。大多数患者患有双侧白内障,而只有一只眼睛的白内障手术在恢复功能视觉中有效,第二只眼科手术会进一步改善与健康相关的生活质量,并且具有成本效益。目前,大多数患者在两只眼中接受白内障手术,如国家准则所推荐的日子,称为延迟连续双侧白内障手术(DSBC)。另一种程序涉及在同一天操作双眼,而是作为单独的程序,称为立即连续的双侧白内障手术(ISBCS)。本研究的目的是评估ISBC的有效性和成本与DSBCS相比,以测试ISBC在有效性方面非逊入的假设,并且在成本效益方面优于ISBC。多中心非较低性随机对照临床试验。研究中患有双侧白内障的患者(18岁或以上)和预期简单的内术和术后预期的双侧白内障手术的指示。患者随机分配给ISBCS或DSBC。初级终点是在手术后4周的4周内,在靶折射中,患者在1.0屈光度内屈服屈光结果的患者的比例。二次结果包括矫正和未矫正的距离视力,并发症,患者报告结果(PROMS),成本效益和预算影响。在先眼外科手术后1周和第二次眼科手术后4周计划进行随访。在先眼手术后3个月,检查并发症的发生,患者填写最终问卷。本研究方案描述了多中心非劣级随机对照试验的设计。关于ISBC的目前往往缺乏有关屈光结果的安全信息。此外,使用建立方法缺乏设计精心设计的成本效益研究。与DSBC相比,BICAT-NL研究将对ISBCS的屈光和成本效益结果提供更多洞察力。本研究于2018年1月17日在Clinicaltrials.gov上注册。(标识符:NCT03400124。

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