Safety, effectiveness, and cost-effectiveness of immediate versus delayed sequential bilateral cataract surgery in the Netherlands (BICAT-NL study): a multicentre, non-inferiority, randomised controlled trial.

BACKGROUND: 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. METHODS: 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 NCT03400124, and is now closed for recruitment. FINDINGS: 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. INTERPRETATION: 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. FUNDING: Research grant from The Netherlands Organization for Health Research and Development (ZonMw) and Dutch Ophthalmological Society.

Effects of clinical parameters on patient-reported outcome in cataract patients: a multicentre study.

PURPOSE: Ophthalmologists tend to evaluate the results of cataract surgery by focusing on the clinical visual and refractive outcomes and the incidence of complications, where patients' main interest might be their ability to perform daily activities. Therefore, there appears to be a need for optimizing effective communication between patients and ophthalmologist about the outcome of cataract surgery. The aim of this multicentre study was to determine the effects of whether the surgery was performed in one or two eyes, ocular comorbidity and per- and postoperative complications on visual function experienced by patients measured with the Catquest-9SF. METHODS: To measure patient-reported outcomes, Catquest-9SF data were collected between 2014 and 2015 in five Dutch hospitals. Data from 870 pairs of questionnaires - completed before and after cataract surgery - were compared with clinical data. Clinical data, retrieved from patients' medical files, consisted of one or two eye surgery, ocular comorbidity and per- and postoperative complications. RESULTS: Quality of vision improved more in patients who had surgery in both eyes and had fewer postoperative complications (both p < 0.001). We found a nonsignificant trend that quality of vision was worse when ocular comorbidity was present. No significant effect of peroperative complications was observed. CONCLUSION: Our results emphasize the added value of the Catquest-9SF as a tool for visual function experienced by patients; the additional information can complement clinical parameters to improve patient-centred approaches in clinical practice.