Avaliação da Efetividade a Longo Prazo e Segurança das Inovações Cirúrgicas do Glaucoma: Revisão Sistemática

Resumo original em inglês

O que aconteceu

A systematic review examining the reporting of long-term safety of glaucoma surgical innovations. Twenty-seven studies met the inclusion criteria and demonstrated effectiveness over the short to medium term. Use of registries to optimise future long-term evaluation is recommended.

To synthesise evidence on the long-term effectiveness and safety of glaucoma surgical innovations introduced since 2004 and appraise reporting quality against IDEAL Stage 4 recommendations, designed to promote transparent study of the long-term impact of surgical innovations.

MEDLINE, EMBASE, and CENTRAL were searched for studies published from January 1, 2014, to October 21, 2024. Eligible studies evaluated novel glaucoma surgery with ≥2 years' follow-up and ≥100 participants. Randomised controlled trials, observational studies, registry analyses, and case series were included. Reporting was assessed using a 16-item adaptation of the IDEAL Stage 4 checklist. Risk of bias was assessed using Cochrane RoB 2, the Newcastle-Ottawa Scale, and the Joanna Briggs Institute case-series checklist.

O que encontraram

The search strategy retrieved 1758 matches, with 27 studies meeting the inclusion criteria. Procedures included iStent, Xen-45 Gel stent, Hydrus microstent, Endoscopic photocoagulation, Trabectome and Kahook dual blade. Follow-up ranged from 2 to 6 years. All studies described design and 22 reported prespecified outcomes sufficiently; however, only 4 explained how missing data were handled. Intraocular-pressure and medication outcomes generally favoured the intervention, but heterogeneity in design, comparators, outcomes, and surgical context precluded pooled estimates. Adverse-event reporting was inconsistent. One cohort study was of poor quality; 14 case series had unclear or unreported methodological items; and 4 RCTs had at least one high-risk domain.

Por que isso importa

Glaucoma surgical innovations appear effective over the medium term, but limited long-term follow-up and inconsistent safety reporting preclude firm conclusions about comparative effectiveness and long-term safety. Standardised reporting and prospective registries are needed.

Resumo publicado sob licença CC BY. A tradução para o português ainda não chegou a este estudo.