Standalone Canaloplasty and Trabeculotomy Using the OMNI Surgical System in Eyes with Primary Open-Angle Glaucoma: A 36-Month Analysis from the American Academy of Ophthalmology IRIS® Registry (Intelligent Research in Sight): Standalone Outcomes of Canaloplasty and Trabeculotomy.

Purpose: To characterize long-term real-world clinical outcomes of standalone canaloplasty and trabeculotomy using the OMNI Surgical System (Sight Sciences) in patients with primary open-angle glaucoma (POAG).

Design: Retrospective, clinical cohort study utilizing the American Academy of Ophthalmology IRIS® Registry (Intelligent Research in Sight) data.

Subjects: Patients/eyes in the IRIS Registry with POAG or ocular hypertension with known laterality on or after January 1, 2016 and undergoing standalone canaloplasty and trabeculotomy using the OMNI Surgical System with at least 6 months and up to 36 months of postoperative follow-up were included. Eyes were excluded for prior filtration surgery, trabeculoplasty within 90 days of the OMNI procedure, or concomitant cataract surgery.

Methods/outcome Measures: Outcome measures included intraocular pressure (IOP) and glaucoma medication changes postoperatively.

Results: 230 eyes in 196 patients were analyzed. Most eyes had moderate (40.0%) or severe (41.3%) POAG. Two-thirds (153 of 230) were pseudophakic. Fewer than half of procedures (44.4%) were performed by glaucoma specialists. Mean baseline IOP was 22.1 (6.4) mmHg and over 36 months of follow-up ranged from 15.1 to 16.7 mmHg (p<0.0001 at every time point compared to baseline), with average eye-level reductions of 5.6-7.1 mmHg. The mean number of glaucoma medications used at baseline was 2.1 (1.5) and over 36 months ranged from 1.1-1.8 medication classes, with statistically significant decreases in utilization through 18 months postoperatively (p≤0.0011) and nonsignificant at months 24 and 36. Eyes with lower baseline IOP (≤18 mmHg) had reductions in medication use through 36 months, and eyes with higher baseline IOP (>18 mmHg) had statistically significant reductions in IOP through 36 months.

Conclusions: Standalone canaloplasty and trabeculotomy provides clinically and statistically significant reductions in IOP through up to 36 months postoperatively. Eyes with lower baseline IOP had long-term glaucoma medication reductions and eyes with higher baseline IOP had statistically significant long-term IOP reductions. Standalone OMNI surgery is a reasonable MIGS option for patients with POAG seeking IOP reduction, medication reduction, or both.