Canaloplasty and trabeculotomy ab interno with the OMNI system combined with cataract surgery in open-angle glaucoma: 12-month outcomes from the ROMEO study

Abstract

To provide safety and effectiveness outcomes 12 months postsurgically for sequential canaloplasty and trabeculotomy with the OMNI system combined with cataract surgery in mild-to-moderate open-angle glaucoma (OAG).

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

“…This combined endpoint accounted for the two different indications for the procedure (IOP reduction or medication reduction) and was achieved by 80% of the combined sample, including 81% of eyes in the low IOP group and 79% of eyes in the high IOP group. 13 In a second, more stringent analysis that required eyes with low baseline IOP to achieve either a >20% IOP reduction or a >1 medication reduction, a 72% success rate was observed. Mean IOP remained stable in the low IOP group (14.1 mmHg to 13.4 mmHg, p > 0.05) and was significantly reduced in the high IOP group (21.9 mmHg to 15.1 mmHg, 31%, p < 0.0001), while mean medications were significantly reduced in both groups (from 1.6 to 0.9 medications per eye [44%], p < 0.001 in low IOP eyes, and from 2.0 to 1.1 [45%], p < 0.01 in high IOP eyes).…”

“…Results were stratified by baseline IOP (low, ≤18 mmHg; high, >18 mmHg) with the assumption that low baseline IOP eyes sought medication reduction and high baseline IOP eyes sought IOP reduction. 13 The primary outcome was the proportion of eyes at month 12 with IOP between 6 and 18 mmHg inclusive or with IOP reduction of ≥20% using the same or fewer medications at month 12 without additional surgery. This combined endpoint accounted for the two different indications for the procedure (IOP reduction or medication reduction) and was achieved by 80% of the combined sample, including 81% of eyes in the low IOP group and 79% of eyes in the high IOP group.…”

“…In a limited number of studies to date, IOP reductions of 20-35% and medication reductions of 25-75% have been reported using the OMNI system either combined with phacoemulsification or on its own. [10][11][12][13][14] In this report, we describe our experience performing trabeculotomy/viscodilation of Schlemm's canal and distal collector channels using the OMNI system as a standalone procedure in both phakic and pseudophakic eyes.…”

Canaloplasty and Trabeculotomy Combined with Phacoemulsification in Open-Angle Glaucoma: Interim Results from the GEMINI Study

“…12 A 12-month interim analysis of a planned 24-month prospective study of 17 eyes of 15 patients with mild to moderate OAG undergoing standalone (9 eyes) or combined (8 eyes) surgery with phacoemulsification found mean IOP reductions of 36% and medication reductions of 75% at 12 months postoperatively. 13 A multicenter retrospective study reporting 14,15 Conceptually, sequential canaloplasty and trabeculotomy procedure lowers IOP by addressing three separate sites of outflow resistance. The juxtacanalicular TM and inner wall of SC are the site of at least 50% of resistance to aqueous outflow in eyes with OAG.…”

“…In studies published to date, titratable viscodilation/canaloplasty (up to 360°) followed by trabeculotomy (up to 360°) performed with this system has produced IOP reductions of 28% to 35% and medication reductions of 25-75% when deployed as a standalone procedure or in combination with phacoemulsification. [12][13][14][15] This report provides early safety and effectiveness outcomes for 360° viscodilation/canaloplasty followed by 180° trabeculotomy with the OMNI system used concomitantly with phacoemulsification.…”