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 (IOP), medication outcomes at 24 months following trabeculotomy/viscodilation using the OMNI® surgical system as a standalone procedure in medically uncontrolled mild-moderate open-angle glaucoma (OAG). Setting Surgical center (Duesseldorf, Germany). Design Retrospective analysis. IOP 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 20% from baseline; mean medication use was 0.5 (-1.4 medications, p 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.