Canaloplasty and Trabeculotomy with the OMNI System in Pseudophakic Patients with Open-Angle Glaucoma: the ROMEO Study.

Provide outcomes up to 12 months post-surgically for sequential canaloplasty and trabeculotomy with the OMNI surgical system (OMNI) in pseudophakic patients with mild to moderate open-angle glaucoma (OAG).
Retrospective, multicenter, single arm study conducted at 10 multi-subspecialty ophthalmology practices and surgery centers located in seven states (AR, CA, KS, LA, MO, NY, TX).
Eligible patients were pseudophakic, with mild/moderate OAG, 12-month follow-up, and medicated intraocular pressure (IOP) ≤36 mmHg on ≤ 4 medications preoperatively. One eye per patient was enrolled.
IRB approved. All available cases meeting eligibility criteria were enrolled. Analysis of secondary endpoints was stratified by baseline (BL) IOP; >18 mmHg (Group 1), ≤ 18 mmHg (Group 2) recognizing that treatment goals differed depending on BL IOP.
Primary success was defined as proportion of patients with ≥ 20% reduction in IOP from BL OR IOP between 6 and 18 mmHg (inclusive) AND on the same or fewer medications without secondary surgical intervention (SSI). Other effectiveness endpoints included mean IOP and number of medications at 12 months. Safety endpoints were best corrected visual acuity (BCVA), adverse events (AE), and secondary surgical interventions (SSI).
Forty-eight patients were enrolled, 24 in each group. Primary success was met by 73%. Mean IOP was reduced in Group 1 (21.8 to 15.6 mmHg, p < 0.0001), and remained controlled in Group 2 (15.4 to 13.9 mmHg, p = 0.24). Medications went from 1.7 ± 1.3 to 1.2 ± 1.3, P = .024 (Group 1) and from 2.0 ± 1.3 to 1.3 ± 1.3, P = .003 (Group 2). AE were typical for the patient population undergoing angle surgery. Those reasonably related to the procedure were mild inflammation (13%), IOP spikes, (6%), hyphema, corneal edema, and BCVA loss, all (4%). 5 patients (10%) required an SSI.
The sequential combination of canaloplasty followed by trabeculotomy performed as standalone procedures using the OMNI system in pseudophakic patients with open angle glaucoma provides effective IOP reduction or sustained IOP control, and meaningful medication reduction for up to 12 months postoperative.

Copyright © 2020. Published by Elsevier Inc.