Standalone Trabeculotomy and Viscodilation of Schlemm's Canal and Collector Channels in Open-Angle Glaucoma Using the OMNI Surgical System: 24-Month Outcomes

Purpose: Intraocular pressure (TOP), medication outcomes at 24 months following trabeculotomy/viscodilation using the OMNI (R) surgical system as a standalone procedure in medically uncontrolled mild-moderate open-angle glaucoma (OAG). Setting: Surgical center (Duesseldorf, Germany). Design: Retrospective analysis. TOP and medication data were collected before surgery and through 24 months. Safety data included adverse events and the need for additional surgery. Methods: Pre-op medication washout. Goldmann tonometry. Number of medications and adverse events (AE) at each time point.Primary outcomes: changes in IOP and medications. Two-sided paired t-tests compare values at each follow-up with baseline, significance p = 0.05. Secondary outcomes: proportion of eyes with IOP reduction of >= 20%, on fewer medications, and medication-free at each time point. Results: This analysis included data from 38 eyes of 27 subjects. Mean (standard deviation) baseline IOP was 24.6 (3.0) mmHg and through 24 months ranged from 12.6 to 14.9 mmHg (p < 0.0001), representing reductions of 10.0-12.0 mmHg. Mean medications were 1.9 (baseline) and through 24 months ranged from 0.0 to 0.5 (70.6-100% reduction) (p < 0.0001). At Month 24, mean IOP was 14.9 mmHg (-10.0 mmHg), and 100% of eyes achieved IOP reduction >20% from baseline; mean medication use was 0.5 (-1.4 medications, p < 0.0001), 84.6% of eyes using >1 fewer medication, and 57.7% were medication-free. The most common adverse event was intraoperative hyphema (44.7%); all resolved spontaneously. There were two secondary procedures for IOP control. Conclusion: The OMNI surgical system provides clinically relevant and statistically significant reductions in both IOP and medications with an excellent safety profile and should be considered in phakic or pseudophakic eyes with mild-moderate OAG requiring IOP or medication reduction, or both.