Canaloplasty: Three-year results of circumferential viscodilation and tensioning of Schlemm canal using a microcatheter to treat open-angle glaucoma

PURPOSE: To report 3-year results of the safety and efficacy of canaloplasty, a procedure involving circumferential viscodilation and tensioning of the inner wall of Schlemm canal to treat open-angle glaucoma. SETTING: Multicenter surgical sites. DESIGN: Nonrandomized multicenter clinical trial. METHODS: This study comprised adult open-angle glaucoma patients having canaloplasty or combined cataract canaloplasty surgery. Qualifying preoperative intraocular pressures (IOPs) were at least 16 mm Hg with historical IOPs of at least 21 mm Hg. A flexible microcatheter was used to viscodilate the full circumference of the canal and to place a trabecular tensioning suture. Primary outcome measures included IOP, glaucoma medication use, and adverse events. RESULTS: Three years postoperatively, all study eyes (n = 157) had a mean IOP of 15.2 mm Hg +/- 3.5 (SD) and mean glaucoma medication use of 0.8 +/- 0.9 compared with a baseline IOP of 23.8 +/- 5.0 mm Hg on 1.8 +/- 0.9 medications. Eyes with combined cataract canaloplasty surgery had a mean 1013 of 13.6 +/- 3.6 mm Hg on 0.3 +/- 0.5 medications compared with a baseline IOP of 23.5 +/- 5.2 mm Hg on 1.5 +/- 1.0 medications. Intraocular pressure and medication use results in all eyes were significantly decreased from baseline at every time point (P<.001). Late postoperative complications included cataract (12.7%), transient IOP elevation (6.4%), and partial suture extrusion through the trabecular meshwork (0.6%). CONCLUSION: Canaloplasty led to a significant and sustained IOP reduction in adult patients with open-angle glaucoma and had an excellent short- and long-term postoperative safety profile.