Standalone Canaloplasty and Trabeculotomy Using the OMNI Surgical System in Patients with Open-Angle Glaucoma: A Systematic Review and Meta-analysis.

Precis: This systematic review and meta-analysis found that standalone OMNI resulted in significant intraocular pressure (IOP) reduction at the 1-month, 6-month, 1-year, and 2-year time points and significantly improved topical medication burden at 1-year.

Purpose: To determine the efficacy of standalone canaloplasty and trabeculotomy using the OMNI Surgical System in open-angle glaucoma (OAG) patients.

Methods: A systematic review was performed using the PubMed, Embase, and Scopus databases for all studies using the OMNITM Surgical System for standalone canaloplasty and trabeculotomy in OAG patients with baseline intraocular pressure (IOP) >18 mmHg (PROSPERO ID: CRD420251044505). Meta-analyses were performed to calculate the IOP change following treatment at 1-month, 6-month, 1-year, and 2-year follow-ups. We also evaluated changes in topical medications and the proportion of medication-free patients at 1 year.

Results: Five studies with 290 eyes at baseline were included. At the 1-month follow-up, there was a significant mean IOP reduction of 7.40 mmHg following standalone OMNI (MD=-7.40; 95% CI: -10.61 to -4.20; P<0.0001). At the 6-month follow-up, mean IOP reduction was 7.25 mmHg (MD=-7.25; 95% CI: -9.60 to -4.89; P<0.0001). At the 1-year follow-up, mean IOP reduction was 7.49 mmHg (MD=-7.49; 95% CI: -9.47 to -5.50; P<0.0001). At 2-year follow-up, mean IOP reduction was 8.77 mmHg (MD=-8.77; 95% CI: -10.35 to -7.19; P<0.0001). Additionally, at the 1-year follow-up, mean reduction of topical medications was 0.77 (MD=-0.77; 95% CI: -1.44 to -0.09; P=0.025), and 46.2% of patients were medication-free (95% CI: 35.6%-57.2%).

Conclusions: The OMNI Surgical System is an effective standalone procedure for canaloplasty and trabeculotomy in OAG patients and led to a significant reduction in IOP at multiple timepoints and medication burden.