Standalone Canaloplasty and Trabeculotomy Using the OMNI Surgical System: A Subgroup Analysis from the American Academy of Ophthalmology IRIS^® Registry (Intelligent Research in Sight)

Purpose: To characterize clinical outcomes of canaloplasty and trabeculotomy using the OMNI Surgical System (Sight Sciences) as a standalone procedure in primary open-angle glaucoma (POAG) subgroups (phakic, pseudophakic; mild, moderate, severe disease). Design: Retrospective, observational cohort study utilizing the American Academy of Ophthalmology (Academy) IRIS^® Registry (Intelligent Research in Sight). Methods: Patients with POAG undergoing standalone OMNI surgery with known laterality between January 2018 and December 2021 and followed for a minimum of 6 months and up to 36 months were included. Analyses divided the cohort into mild, moderate, and severe glaucoma subgroups (International Classification of Disease-10 coding), and lens status (phakic and pseudophakic) subgroups. Outcomes included changes in intraocular pressure (IOP) and glaucoma medication class use. Results: Data from 220 eyes of 187 patients were analyzed. Mean IOP reductions from baseline were clinically and statistically significant at every time point across disease severity groups; mild, 5.5–9.4 mmHg (p < 0.0026); moderate, 5.3–7.4 mmHg (p < 0.0001 at all time points); severe, 5.8–7.6 mmHg (p < 0.0004). Mean IOP reductions were 5.1–7.4 mmHg in phakic eyes and 5.8–6.7 mmHg in pseudophakic eyes; p < 0.0001 all time points, both subgroups. Mean medication reductions from baseline were clinically and statistically significant at month 6 and month 12 in the mild and severe groups, and insignificant at all other time points in the three groups. Medication reductions averaged 0.3–0.4 in phakic eyes (non-significant) and statistically significant reductions of 0.4–0.6 in pseudophakic eyes (months 6, 12, and 18 [p < 0.01]), with non-significant reductions (0.3–0.4 medications) at later time points. Conclusion: In this study, standalone OMNI surgery significantly decreased IOP for up to 3 years regardless of disease severity or lens status. This procedure may be considered for phakic or pseudophakic patients with all stages of glaucoma whose therapeutic goals fall within the ranges achievable with standalone surgery.