Evaluating Long-Term Effectiveness and Safety of Glaucoma Surgical Innovations: A Systematic Review

PRCIS: A systematic review examining reporting of long-term safety of glaucoma surgical innovations. 27 studies met inclusion criteria and demonstrated effectiveness over the short to medium term. Use of registries to optimise future long-term evaluation is recommended. PURPOSE: 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. METHODS: MEDLINE, EMBASE, and CENTRAL were searched for studies published from 1 January 2014 to 21 October 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. RESULTS: The search strategy retrieved 1758 matches, with 27 studies meeting inclusion criteria. Procedures included iStent, Xen-45 Gel stent, Hydrus microstent, Endoscopic photocoagulation, Trabectome and Kahook dual blade. Follow-up ranged from two to six years. All studies described design and 22 reported pre-specified outcomes sufficiently; however, only four 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 poor quality; 14 case series had unclear or unreported methodological items; and four RCTs had at least one high-risk domain. CONCLUSIONS: 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.