Original Title: Seguridad, efectividad y coste-efectividad de la cirugía de cataratas bilateral y simultánea frente a la cirugía bilateral de cataratas en dos tiempos

Authors' objectives: To assess the safety, clinical and self-perceived effectiveness and costutility of bilateral and simultaneous cataract surgery (CCBS) against bilateral cataract surgery in two phases (CCDT).

Authors' results and conclusions: RESULTS: There were no differences for the incidence of either per or postoperatory surgical complications between CCBS and CCDT. The objective assessment of clinical effectiveness following the intervention, as measured by visual acuity, showed no differences between the CCBS and CCDT. Patients receiving CCBS achieved a faster self-perceived improvement of HRQL, measured by means of VF-14 questionnaire, within the first month, although no statistical differences were observed, after one year of follow-up, between interventions. The VAS tariff of the generic EQ-5D questionnaire shows that CCBS patients have a greater improvement during the first month of follow-up and, despite their less favourable score at baseline. After second eye surgery, patients with CCDT achieved a slightly higher score than CCBS patients. However, despite the greater improvement for CCBS group, until 1 year follow up, their score remained slightly lower than CCDT. At one month after surgery, the effect size obtained by the VF-14 questionnaire was moderate for patients in CCBS and small for patients in CCDT. However, differences between groups disappeared after the second eye surgery. The incremental cost per QALY gained for the CCBS was dominant (lower cost and greater effectiveness) comparing to CCDT. Sensitivity analysis did not significantly change the outcomes of the economic evaluation. CONCLUSIONS: CCBS, as a surgical alternative for cataract patients, is as safe and effective as conventional CCDT. No differences were found among interventions for HRQL measured by VF-14 questionnaire. CCBS was more efficient than CCDT for both patients and health care providers. To warrant generalization of these results caution should be considered on adequate selection of patients and expert surgeons, as well as implementation of evidence based surgical protocols independently at every eye.

Authors' methods: Design: Pragmatic and multicentric randomized clinical trial with 807 patients (417 for CCBS and 390 for CCDT). Setting: Patients were recruited from the waiting lists for cataract surgery of the Canary Islands Health Service in the Health Authority of Gran Canaria. Subjects of study: Patients were previously diagnosed of bilateral cataract requiring surgical treatment. Outcome measures: As safety measure information about per and postoperatory complications were obtained for both treatment alternatives. As effectiveness measures visual acuity (corrected and noncorrected) and generic (EQ-5D) and specific (VF-14) health related quality of life (HRQL) instruments were used. To estimate the costeffectiveness ratio information was gathered on health resources utilisation by means of a validated questionnaire and accounting for hospitals. Follow-up: As safety measure information about complications were obtained for both treatment alternatives during the month following the intervention. The clinical effectiveness measures and resource utilisation questionnaire were applied together, before and after CCBS. For CCDT, both measures were also applied after first eye surgery. The HRQL was assessed one month and a year after intervention. Data analyses: Effects sizes were estimated for HRQL differences. And ANOVA with repeated measures was performed to assess the effect of time and interventions. Cost-utility assessment was performed by mathematical modelling to obtain the incremental costs for quality adjusted life years gained (QALYS).

Project Status: Completed

Year Published: 2007

URL for published report: https://sescs.es/seguridad-efectividad-y-coste-efectividad-de-la-cirugia-de-cataratas/

English language abstract: An English language summary is available

Publication Type: Full HTA

Country: Spain

Organisation Name: Canary Health Service

Contact Address: Dirección del Servicio. Servicio Canario de la Salud, Camino Candelaria 44, 1ª planta, 38109 El Rosario, Santa Cruz de Tenerife

Contact Name: sescs@sescs.es

Contact Email: sescs@sescs.es