Background: To report 3-year results investigating the safety and efficacy of canaloplasty, a procedure involving circumferential viscodilation of Schlemm's canal and tensioning of the inner canal wall to treat open-angle glaucoma.
Methods: This was a prospective, multi-center, interventional study of 109 eyes of 109 adult, open-angle glaucoma patients undergoing canaloplasty or combined cataract-canaloplasty surgery. Qualifying preoperative intraocular pressures (IOP) were at least 16 mmHg with historical IOPs of at least 21 mmHg with or without medical therapy. 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 usage, and adverse events.
Results: Eyes with canaloplasty showed a mean baseline IOP of 23.0 ± 4.3 mmHg and mean glaucoma medication usage of 1.9 ± 0.7 medications, which decreased to a mean IOP of 15.1 ± 3.1 mmHg on 0.9 ± 0.9 medications at 3 years postoperatively. Eyes with combined cataract-canaloplasty surgery showed a mean baseline IOP of 24.3 ± 6.0 mmHg on 1.5 ± 1.2 medications, which decreased to a mean IOP of 13.8 ± 3.2 mmHg on 0.5 ± 0.7 medications at 3 years. Intraocular pressure and medication use results for all study eyes were significantly decreased from baseline (p <0.00001) at all intervals. Late postoperative complications included cataracts (19.1%) and transient IOP elevation (1.8%).
Conclusions: Canaloplasty demonstrated significant and sustained IOP reductions accompanied by an excellent short- and long-term safety profile in adult patients with open-angle glaucoma.