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.

An update on immediate sequential bilateral cataract surgery.

PURPOSE OF REVIEW: The aim of this study was to present an overview of recent publications and opinions in the field of same-day bilateral cataract surgery. RECENT FINDINGS: A Cochrane review was published comparing immediate sequential bilateral cataract surgery (ISBCS) and delayed sequential bilateral cataract surgery (DSBCS) with regard to safety outcomes, costs and cost-effectiveness. In addition, several large database studies provided more information on incidences of rare complications such as unilateral and bilateral endophthalmitis rates. SUMMARY: Recently available evidence showed that ISBCS is an effective and cost-effective alternative to DSBCS. Nonetheless, additional (randomized) registry studies, randomized controlled trials and cost-effectiveness studies are needed to evaluate bilateral endophthalmitis rates, refractive outcomes and cost-effectiveness of ISBCS compared with DSBCS.

Immediate sequential bilateral surgery versus delayed sequential bilateral surgery for cataracts.

BACKGROUND: Age-related cataract affects both eyes in most cases. Most people undergo cataract surgery in both eyes on separate days, referred to as delayed sequential bilateral cataract surgery (DSBCS). An alternative procedure involves operating on both eyes on the same day, but as two separate procedures, known as immediate sequential bilateral cataract surgery (ISBCS). Potential advantages of ISBCS include fewer hospital visits for the patient, faster visual recovery, and lower healthcare costs. Nevertheless, concerns exist about possible bilateral, postoperative, sight-threatening adverse effects with ISBCS. Therefore, there is a clear need for evaluating evidence regarding the safety, effectiveness, and cost-effectiveness of ISBCS versus DSBCS. OBJECTIVES: To assess the safety of ISBCS compared to DSBCS in people with bilateral age-related cataracts and to summarise current evidence for the incremental resource use, utilities, costs, and cost-effectiveness associated with the use of ISBCS compared to DSBCS in people with bilateral age-related cataracts (primary objectives). The secondary objective was to assess visual and patient-reported outcomes of ISBCS compared to DSBCS in people with bilateral age-related cataracts. SEARCH METHODS: We searched CENTRAL (which contains the Cochrane Eyes and Vision Trials Register; 2021, Issue 5); Ovid MEDLINE; Ovid Embase; the ISRCTN registry; ClinicalTrials.gov; the WHO ICTRP; and DARE and NHS EED on the CRD Database on 11 May 2021. There were no language restrictions. We limited the searches to a date range of 2007 onwards. SELECTION CRITERIA: We included randomised controlled trials (RCTs) to assess complications, refractive outcomes, best-corrected distance visual acuity (BCDVA) and patient-reported outcome measures (PROMs) with ISBCS compared to DSBCS. We included non-randomised (NRSs), prospective, and retrospective cohort studies comparing ISBCS and DSBCS for safety assessment, because of the rare incidence of important adverse events. To assess cost-effectiveness of ISBCS compared to DSBCS, we included both full and partial economic evaluations, and both trial-based and model-based economic evaluations. DATA COLLECTION AND ANALYSIS: We used standard Cochrane methodological procedures and assessed risk of bias for NRSs using the ROBINS-I tool. For cost-evaluations, we used the CHEC-list, the CHEERS-checklist, and the NICE-checklist to investigate risk of bias. We assessed the certainty of evidence with the GRADE tool. We reported results for economic evaluations narratively. MAIN RESULTS: We included 14 studies in the review; two RCTs, seven NRSs, and six economic evaluations (one study was both an NRS and economic evaluation). The studies reported on 276,260 participants (7384 for ISBCS and 268,876 for DSBCS) and were conducted in Canada, the Czech Republic, Finland, Iran, (South) Korea, Spain (Canary Islands), Sweden, the UK, and the USA. Overall, we considered the included RCTs to be at 'high to some concerns' risk of bias for complications, 'some concerns' risk of bias for refractive outcomes and visual acuity, and 'high' risk of bias for PROMs. The overall risk of bias for NRSs was graded 'serious' regarding complications and 'serious to critical' regarding refractive outcomes.  With regard to endophthalmitis, we found that relative effects were estimated imprecisely and with low certainty, so that relative estimates were not reliable. Nonetheless, we found a very low risk of endophthalmitis in both ISBCS (1/14,076 participants) and DSBCS (55/556,246 participants) groups. Based on descriptive evidence and partially weak statistical evidence we found no evidence of an increased risk of endophthalmitis with ISBCS. Regarding refractive outcomes, we found moderate-certainty (RCTs) and low-certainty (NRSs) evidence there was no difference in the percentage of eyes that did not achieve refraction within 1.0 dioptre of target one to three months after surgery (RCTs: risk ratio (RR) 0.84, 95% confidence interval (CI) 0.57 to 1.26; NRSs: RR 1.02, 95% CI 0.60 to 1.75). Similarly, postoperative complications did not differ between groups (RCTs: RR 1.33, 95% CI 0.52 to 3.40; NRSs: 1.04, 95% CI 0.47 to 2.29), although the certainty of this evidence was very low for both RCTs and NRSs. Furthermore, we found low-certainty (RCTs) to very low-certainty (NRSs) evidence that total costs per participant were lower for ISBCS compared to DSBCS, although results of individual studies could not be pooled. Only one study reported on cost-effectiveness. This study found that ISBCS is cost-effective compared to DSBCS, but did not measure quality-adjusted life years using preferred methods and calculated costs erroneously. Finally, regarding secondary outcomes, we found limited evidence on BCDVA (data of two RCTs could not be pooled, although both studies individually found no difference between groups (very low-certainty evidence)). Regarding PROMs, we found moderate-certainty evidence (RCTs only) that there was no difference between groups one to three months after surgery (standardised mean difference -0.08, 95% CI -0.19 to 0.03). AUTHORS' CONCLUSIONS: Current evidence supports there are probably no clinically important differences in outcomes between ISBCS and DSBCS, but with lower costs for ISBCS. However, the amount of evidence is limited, and the certainty of the evidence was graded moderate to very low. In addition, there is a need for well-designed cost-effectiveness studies.

Ophthalmologists' attitudes toward immediate sequential bilateral cataract surgery: Dutch national survey.

PURPOSE: To evaluate current practice patterns of immediate sequential bilateral cataract surgery (ISBCS) in the Netherlands and assess ophthalmologists' attitudes toward performing ISBCS in future cataract care. SETTING: Dutch ophthalmic society members. DESIGN: Cross-sectional study (national survey). METHODS: An electronic survey on ISBCS was sent as part of an annual survey on cataract practice patterns to members of the Dutch ophthalmic society. Questions regarding current ISBCS practice patterns, willingness to perform ISBCS routinely in future care, reasons for performing ISBCS, and reasons for not performing ISBCS were included. Data were analyzed using descriptive statistics. RESULTS: 237 (45.6%) of 520 survey recipients responded to the overall survey. Data on the ISBCS questions were available from 227 respondents. 62 ophthalmologists (27.3%) currently performed ISBCS, predominantly in low patient volumes (90.3% on 1 to 5 patients per month). However, 108 (47.6%) of 227 ophthalmologists considered performing ISBCS routinely in future practice. Procedures for which ISBCS was mainly considered included age-related cataract surgery using topical and general anesthesia. Availability of separate products and instruments for both eyes and patient advantages were considered of high importance when performing ISBCS. Main reasons for not performing ISBCS included the risk for endophthalmitis and potential medicolegal aspects. CONCLUSIONS: Although ISBCS is currently not a routine procedure in the Netherlands, it is considered by almost 50% of surgeons. To improve implementation on a national level, potential barriers identified in this survey (fear of bilateral endophthalmitis, potential medicolegal issues, and a lack of availability of separate products for both eyes) should be addressed.

Predictive accuracy of an intraoperative aberrometry device for a new monofocal intraocular lens.

PURPOSE: To evaluate refractive outcomes for the Clareon monofocal intraocular lens (IOL) in terms of achieved target refraction for the ORA (ALCON) intraoperative wavefront aberrometry device and preoperative noncontact biometry. SETTING: University Eye Clinic Maastricht, Maastricht University Medical Center+, the Netherlands. DESIGN: Prospective observational clinical trial. METHODS: Patients with bilateral age-related cataracts undergoing phacoemulsification, either by delayed sequential surgery or on the same day, were included in the study. Exclusion criteria were an increased risk for refractive surprise or complicated surgery. Implanted IOL power was based on noncontact optical biometry data using the Barrett Universal II (BU-II) formula, optimized for the Clareon IOL. Postoperative subjective refraction was measured 4 to 6 weeks after surgery. Catquest-9SF questionnaires were completed preoperatively and 3 months after surgery. RESULTS: 100 eyes (51 patients) were included. The percentages of eyes within 1.0 diopters (D), 0.75 D, 0.50 D, and 0.25 D of target for ORA vs BU-II were 84% (84 eyes), 72% (72 eyes), 57% (57 eyes), and 21% (21 eyes) vs 97% (97 eyes), 88% (88 eyes), 77% (77 eyes), and 53% (53 eyes), respectively. Mean absolute prediction error was significantly higher for ORA vs preoperative biometry (P < .001). After global optimization, the prediction accuracy of ORA improved significantly (P < .001). Catquest-9SF questionnaires showed improved levels of ability at 3 months after surgery (P < .001). CONCLUSIONS: This study showed lower percentages of eyes within target refraction for ORA (prior to lens constant optimization) compared with the BU-II formula when implanting the Clareon IOL. However, prediction accuracy of ORA improved significantly after global optimization. Therefore, further intraoperative measurements, postoperative measurements, and optimization are needed to improve the ORA prediction for this IOL.

Long-term Outcomes of Repeated Corneal Transplantations: A Prospective Dutch Registry Study.

PURPOSE: To compare long-term outcomes of repeated corneal transplantations (CT), based on primary indication (Fuchs endothelial dystrophy [FED] vs pseudophakic bullous keratoplasty [PBK]), surgical technique (penetrating keratoplasty [PK] vs endothelial keratoplasty [EK]), and indication for repeated grafting. METHODS: In this nonrandomized treatment comparison with national registry data (Netherlands Organ Transplantation Registry, NOTR), data on all consecutive repeated CT following primary PK or EK for FED and PBK between 1994 and 2015 were analyzed, with a maximal follow-up of 5 years. Regraft survival was analyzed using Kaplan-Meier survival curves and univariable and multivariable Cox regression analysis. Secondary outcomes best-corrected visual acuity, spherical equivalent, and refractive astigmatism were compared using linear mixed-model analysis. RESULTS: A total of 332 repeated CT were analyzed. The number of regrafts increased significantly between 2007 and 2015 (P = .001). Overall 5-year regraft survival was 60% and was higher for FED vs PBK (77% vs 45%, HR = 0.40, P = .001), and re-EK vs re-PK (81% vs 55%, HR = 0.51, P = .041). However, multivariable analysis showed no significant difference in survival based on primary indication, surgical technique, and indication for regrafting. Corrected for baseline, secondary outcomes also did not differ between groups. CONCLUSIONS: We found a significant increase in repeated CT, coinciding with the introduction of EK in the Netherlands. While univariable analysis suggested better overall regraft survival for FED and (re-)EK, multivariable analysis showed no such difference. This may be owing to allocation of favorable cases to undergo (re-)EK. Similarly, secondary outcomes were determined by the primary CT technique.