Systematic review and meta-analysis of the clinical effectiveness, safety, humanistic and economic burden of the OMNI ^® surgical system and its predecessors

ObjectiveThe aim of this systematic review and meta-analysis was to assess the clinical, humanistic, and economic evidence of the OMNI^® Surgical System (OMNI), Visco360 and Trab360 for open-angle glaucoma (OAG).MethodsSearch strategies were applied across MEDLINE^®, Web of Science™, Cochrane (January 2016-April 2024) on 16th April 2024. Congress proceedings (2021-2024) were searched in July 2024. Studies containing ≥15 patients that reported clinical, humanistic or economic outcomes associated with the use of OMNI, Visco360 or Trab360 for the treatment of adults with OAG were included. Structured summaries were used to summarize findings and a meta-analysis synthesized the data. Risk of bias was assessed using the Newcastle-Ottawa and CHEERS checklists. The protocol was registered on PROSPERO (CRD42024536680).ResultsAmong 29 included publications, 27 reported clinical and 2 reported economic outcomes. OMNI significantly reduced intraocular pressure (IOP) with mean IOP <18 mmHg (11.5-17.2 mmHg) at 12 months when used standalone or combined with cataract surgery. The meta-analysis confirmed statistically significant, comparable IOP reductions at months 6, 12 and 24. IOP-lowering medication use decreased from 0.9-3.4 at baseline to 0.1-2.2 at month 12 (standalone and combination)<b>;</b> these continued months 24-36. Adverse events were generally mild and transient.ConclusionOMNI consistently reduced IOP and medication use demonstrating sustained effects over 24--36 months with a favorable safety profile, thus supporting its use in patients with OAG. Limitations of this review include the absence of randomized controlled trials. Six studies were assessed as good quality, the remainder showed risk of bias.