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 medicationfree. 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.

A Multicenter 12-Month Retrospective Evaluation of Canaloplasty and Trabeculotomy in Patients with Open-Angle Glaucoma: The ROMEO 2 Study

“…These include the prospective, multicenter (US) GEMINI study which included a preoperative and terminal medication washout with 149 eyes undergoing OSS with phacoemulsification cataract surgery, 4 , 5 a single-center, prospective 12-month Polish study of standalone and combination procedures, 6 and a single-center German study with 24-month data for standalone cases that included both phakic and pseudophakic eyes. 7 The GEMINI study showed an IOP decrease of 8.2 mmHg (from 23.8 to 15.6 mmHg, −35%) from preoperative to month 12 (both unmedicated following medication washout) and medications decreased from 1.8 to 0.4. Comparison of the GEMINI patient demographics and glaucoma characteristics to those of the present study show that, on average, the GEMINI patients were somewhat younger (68.3 years vs 72.9 years), had slightly less advanced glaucoma (visual field MD −3.7 dB vs −4.5 dB), and were more uniformly POAG (93% vs 84% for the +cataract cohort).…”

“…5 In a retrospective case series, Klabe reported IOP at 12 and 24 months of 14.7 and 14.9 mmHg at 12 and 24 months on 0.4 and 0.5 medications, while Grabska-Liberek reported, in a prospective case series, IOP of 12.7 mmHg on 0.64 medications at 12 months. 6,7 IOP outcomes in patients treated with OSS show a remarkable consistency across studies, typically in the mid-teens. 8 There is more apparent variability in medication reduction outcomes, but this can, at least in part, be attributed to the use of a baseline medication washout in some of the studies.…”

Short-Term Efficacy of Combined ab Interno Canaloplasty and Trabeculotomy in Pseudophakic Eyes with Open-Angle Glaucoma

“…Klabe et al evaluated postoperative outcomes of 38 eyes after standalone ab interno canaloplasty and trabeculotomy reporting a hyphema rate of 44.7% with none being >1 mm. 15 Comparatively, only 4.2% of eyes included in the ROMEO study experienced clinically significant hyphema defined as layered and >1 mm and/or persisting >1 week and/or requiring secondary intervention. 13 Only 2 eyes (3.0%) required additional surgery for IOP.…”

“…These findings parallel prior studies, which reported similar reductions in IOP and medication burden sustained out to 12 and 24-months. 13 , 15 However, a key point of distinction is this study’s inclusion of pseudophakic eyes with severe glaucoma.…”

“…Few studies have addressed the use of this device as a standalone procedure, and while preliminary studies have shown promising results they do not include patients with severe glaucoma. [12][13][14][15] The purpose of this study was to retrospectively evaluate the outcomes of the OMNI surgical system as a standalone procedure in pseudophakic eyes with open angle glaucoma.…”