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

Abstract

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 < 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.

Keywords:

• primary open-angle glaucoma
• trabeculotomy
• viscodilation
• OMNI surgical system

Acknowledgments

We are grateful to Tony Realini, MD, MPH (Hypotony Holdings, LLC) for creating the initial draft of the manuscript. We thank Jaime E Dickerson, PhD for additional revision and editorial assistance. The manufacturer of the OMNI Surgical System, Sight Sciences, provided financial assistance to support writing, preparation, and publication of the manuscript. This work was otherwise self-funded.

Author Contributions

Both authors made a significant contribution to the work reported, whether in the conception, study design, execution, acquisition of data, analysis and interpretation, or in all these areas; took part in drafting, revising or critically reviewing the article; gave final approval of the version to be published; have agreed on the journal to which the article has been submitted; and agree to be accountable for all aspects of the work.

Disclosure

A preliminary version of this study limited to 12-month outcomes was published as a digital supplement in CRST Europe. Dr Karsten Klabe reports grants from Sight Sciences, Inc, manufacturer of the OMNI Surgical System, during the conduct of the study. Dr Hakan Kaymak has nothing to disclose.