Canaloplasty and Trabeculotomy with the OMNI System in Patients with Open-Angle Glaucoma: Two-Year Results from the ROMEO Study

Abstract

Purpose

To provide extended safety and effectiveness follow-up for eyes treated with circumferential canaloplasty and trabeculotomy (CP+TR) that were included in the 12-month ROMEO study.

Setting

Seven multi-subspecialty ophthalmology practices located in 6 states (Arkansas, California, Kansas, Louisiana, Missouri, and New York).

Design

Retrospective, multicenter, IRB approved.

Subjects

Eligible eyes had mild–moderate glaucoma and were treated with CP+TR with cataract surgery or as a standalone intervention.

Methods

Main outcome measures were mean IOP, mean number of ocular hypotensive medications, mean change in number of medications, proportion of patients with a ≥20% reduction in IOP or with IOP ≤18 mmHg, and proportion of patients medication free. Safety outcomes were adverse events and secondary surgical interventions (SSI).

Results

Eight surgeons at 7 centers contributed 72 patients stratified by pre-operative intraocular pressure (IOP); >18 mmHg (Grp1), ≤18 mmHg (Grp2). Mean follow-up of 2.1 years (min 1.4, max 3.5). 2-year IOP (SD) was 15.6 mmHg (−6.1 mmHg, −28% from baseline) on 1.4 medications (−0.9, −39%) for Grp1 with cataract surgery; 14.7 mmHg (−7.4 mmHg, −33% from baseline) on 1.6 medications (−0.7, −15%) for Grp1 standalone, 13.7 mmHg (−0.6 mmHg, −4.2%) on 1.2 medications (−0.8, −35%) for Grp2 with cataract surgery, 13.3 mmHg (−2.3 mmHg, −14.7%) on 1.2 medications (−1.0, −46%) for Grp2 standalone. The proportion of patients at 2 years with either a ≥20% IOP reduction or IOP between 6 and 18 mmHg and no increase in medication or SSI was 75% (54 of 72, 95% CI 69.9%, 80.1%). One-third of patients (24 of 72) were medication free whereas 9 of 72 were pre-surgical. No device-related adverse events during extended follow-up; 6 eyes (8.3%) required additional surgical or laser intervention for IOP control after 12 months.

Conclusion

CP+TR provides effective IOP control that is sustained for 2 years or more.

Keywords:

• canaloplasty
• trabeculotomy
• MIGS
• OMNI
• glaucoma

Data Sharing Statement

The authors do not intend to share participant-level data. Other queries or requests should be directed to the corresponding author (JD).

Disclosure

This study was supported by Sight Sciences Inc., the manufacturer of the OMNI Surgical System. JED is an employee of Sight Sciences, Inc. SDV consults for Sight Sciences and reports grants from Sight Sciences, grants from Alcon, grants from Glaukos, grants, personal fees from Carl Zeiss Meditec, patent royalty from Iridex, grants, personal fees from AbbVie, patent royalty from Volk, grants from RxSight, grants, personal fees from iStar Medical, grants, personal fees from Intellon, grants from Bausch & Lomb, grants from Santen, during the conduct of the study. BKW consults and speaks for Sight Sciences. AC reports compensation as PI in ROMEO Study from Sight Sciences, during the conduct of the study; compensation as PI in ROMEO Study from Sight Sciences, outside the submitted work. The authors report no other conflicts of interest in this work.