Canaloplasty and trabeculotomy ab interno with the OMNI system combined with cataract surgery in open-angle glaucoma: 12-month outcomes from the ROMEO study.
Hirsch Louis, Cotliar Jeremy, Vold Steven, Selvadurai Deepan, Campbell Anita, Ferreira Gabriel, Aminlari Ardalan, Cho Andrew, Heersink Sebastian, Hochman Michael
AI Summary
The OMNI system combined with cataract surgery effectively lowered eye pressure and reduced medication use for 12 months in mild-to-moderate open-angle glaucoma, offering a safe treatment option.
Abstract
Purpose
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).
Setting
Eleven ophthalmology practices and surgery centers located in 8 U.S. states.
Design
Retrospective, multicenter, single arm.
Methods
Twelve surgeons contributed 81 patients meeting eligibility criteria: OAG, 12-month follow-up, and medicated intraocular pressure (IOP) 36 mm Hg or less on 4 or less medications preoperatively. Analysis was stratified by baseline IOP: more than 18 mm Hg (Group 1) and 18 mm Hg (Group 2) or less. Success was defined as proportion with 20% reduction or greater in IOP or IOP between 6 and 18 mm Hg (inclusive) and on the same or fewer medications without secondary surgical intervention (SSI). Other endpoints included mean IOP and medications at 12 months. Safety included corrected distance visual acuity and adverse events (AEs).
Results
Of the 81 patients included, primary success was met by 79% in Group 1 and 81% in Group 2. The mean IOP was reduced in Group 1 (21.9 to 15.1 mm Hg, P < .0001) and remained controlled in Group 2 (14.1 to 13.4 mm Hg, P = .3177). Medications went from 2.0 ± 1.3 to 1.1 ± 1.1 in Group 1 and from 1.6 ± 1.3 to 0.9 ± 1.2 in Group 2. AEs were typical for cataract or angle surgery: mild inflammation (11%), IOP spikes (5%), and hyphema (4%). Four patients (5%) required an SSI.
Conclusions
The OMNI system provided effective IOP reduction, sustained IOP control, and meaningful medication reduction for up to 12 months postoperative.
MeSH Terms
Shields Classification
Key Concepts6
In a retrospective, multicenter, single-arm study of 81 patients with mild-to-moderate open-angle glaucoma, sequential canaloplasty and trabeculotomy with the OMNI system combined with cataract surgery resulted in a primary success rate of 79% at 12 months for patients with baseline IOP > 18 mm Hg (Group 1).
In a retrospective, multicenter, single-arm study of 81 patients with mild-to-moderate open-angle glaucoma, sequential canaloplasty and trabeculotomy with the OMNI system combined with cataract surgery resulted in a primary success rate of 81% at 12 months for patients with baseline IOP ≤ 18 mm Hg (Group 2).
In a retrospective, multicenter, single-arm study of 81 patients with mild-to-moderate open-angle glaucoma, sequential canaloplasty and trabeculotomy with the OMNI system combined with cataract surgery reduced mean intraocular pressure (IOP) from 21.9 mm Hg to 15.1 mm Hg (P < .0001) at 12 months in patients with baseline IOP > 18 mm Hg (Group 1).
In a retrospective, multicenter, single-arm study of 81 patients with mild-to-moderate open-angle glaucoma, sequential canaloplasty and trabeculotomy with the OMNI system combined with cataract surgery maintained mean intraocular pressure (IOP) from 14.1 mm Hg to 13.4 mm Hg (P = .3177) at 12 months in patients with baseline IOP ≤ 18 mm Hg (Group 2).
In a retrospective, multicenter, single-arm study of 81 patients with mild-to-moderate open-angle glaucoma, sequential canaloplasty and trabeculotomy with the OMNI system combined with cataract surgery reduced glaucoma medications from 2.0 ± 1.3 to 1.1 ± 1.1 at 12 months in patients with baseline IOP > 18 mm Hg (Group 1).
In a retrospective, multicenter, single-arm study of 81 patients with mild-to-moderate open-angle glaucoma, adverse events typical for cataract or angle surgery following sequential canaloplasty and trabeculotomy with the OMNI system combined with cataract surgery included mild inflammation (11%), IOP spikes (5%), and hyphema (4%). Four patients (5%) required a secondary surgical intervention.
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