12-month interim results of a prospective study of patients with mild to moderate open-angle glaucoma undergoing combined viscodilation of Schlemm’s canal and collector channels and 360° trabeculotomy as a standalone procedure or combined with cataract surgery

Abstract

Purpose: To characterize clinical outcomes of combined viscodilation of Schlemm’s canal and collector channels and 360° trabeculotomy as a standalone procedure or combined with cataract surgery in eyes with mild to moderate open-angle glaucoma (OAG). Methods: In this prospective case series, the OMNI glaucoma surgical platform (Sight Sciences, Menlo Park, CA) was utilized to perform the procedure either combined with phacoemulsification or as a standalone procedure. Changes from baseline in intraocular pressure (IOP) and IOP-lowering medications were evaluated through the first 12 months of a planned 24-month follow-up period. Results: Among 17 eyes of 15 subjects, mean IOP was reduced from 20.4 mmHg to 12.7–13.7 mmHg through 12 months of follow-up ( p < 0.001 at every time point) and mean medications reduced from 2.5 to 0.1–0.6 ( p < 0.001 at every time point). IOP reductions in eyes undergoing standalone surgery were approximately 2–4 mmHg greater at each time point compared to eyes undergoing surgery combined with phacoemulsification; this may be related to a higher baseline IOP in the former eyes (22.1 vs 18.5 mmHg). Six eyes developed hyphema, of which three required washout for elevated IOP on the first postoperative day; six additional eyes had IOP elevations that resolved with medical management. Conclusion: Viscodilation of Schlemm’s canal and collector channels paired with ab interno trabeculotomy performed with a single integrated instrument (OMNI), whether as standalone or combined with phacoemulsification, effectively lowers both IOP and the need for IOP-lowering medications through 12 months of follow-up.

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

“…For eyes with progressive OAG despite medical therapy, a modest additional IOP reduction of 20% or more has been shown to significantly reduce the risk of further progression, 17 and a 20% IOP reduction is an FDA accepted endpoint 18 used in MIGS registry trials. 19,20 In our study and others, [10][11][12][13][14] mean IOP reductions of 20% or more have been consistently reported overall, and in our study, the specific endpoint of >20% IOP reduction was achieved by 97% of eyes at Month 12 and 100% at Month 24. This was not attributable to greater medication use postoperatively, as nearly all eyes required fewer medications postoperatively and the majority of eyes were medication-free at 12 and 24 months.…”

“…21 Minimizing or eliminating these factors would be expected to improve patients' quality of life, which is the ultimate goal of glaucoma therapy. 22,23 In our study and others, [10][11][12][13][14] mean medication reductions of 40-50% or more, and medication-free rates of ~65-75% have been reported. 10,14 The current study's impact is limited by some of these factors.…”

“…A retrospective study in 24 eyes with all stages of glaucoma reported mean IOP reduction of ~40% and mean medication reduction of 50% 18 months following surgery performed in combination with phacoemulsification, and 40% and 33%, respectively, when performed as a standalone procedure. 11 Another retrospective study in 41 eyes with mild to moderate POAG undergoing surgery either as a standalone procedure or in combination with phacoemulsification reported mean IOP reduction in all eyes of 5.6 mmHg and in eyes with baseline IOP > 22 mmHg of 9.6 mmHg 4 months postoperatively (baselines not reported). 10 A more recent retrospective analysis of 69 eyes with mild to moderate OAG undergoing surgery combined with phacoemulsification found IOP reduction of 18% overall and 28% and 13% in eyes with high and low baseline IOP, respectively; medication reductions were 40% overall and 44% and 34% in high and low baseline IOP eyes, respectively.…”

“…The surgical procedure has been described previously. 9,11,15 Briefly, under gonioscopic view, the handpiece tip is introduced into the OVD-filled anterior chamber through a temporal corneal incision and advanced to the nasal angle. The tip then engages and passes through TM, and the microcatheter is deployed via the cannula into and through 180° of Schlemm's canal.…”

“…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.…”