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Purpose  To compare the outcomes of canaloplasty and trabeculectomy in open‐angle glaucoma.    Methods  This prospective, randomized clinical trial included 62 patients who randomly received trabeculectomy ( n  = 32) or canaloplasty ( n  = 30) and were followed up prospectively for 2 years. Primary endpoint was complete (without medication) and qualified success (with or without medication) defined as an intraocular pressure ( IOP ) of ≤18 mmHg (definition 1) or  IOP  ≤21 mmHg and ≥20%  IOP  reduction (definition 2),  IOP  ≥5 mmHg, no vision loss and no further glaucoma surgery. Secondary endpoints were the absolute  IOP  reduction, visual acuity, medication, complications and second surgeries.    Results  Surgical treatment significantly reduced  IOP  in both groups (p < 0.001). Complete success was achieved in 74.2% and 39.1% (definition 1, p = 0.01), and 67.7% and 39.1% (definition 2, p = 0.04) after 2 years in the trabeculectomy and canaloplasty group, respectively. Mean absolute  IOP  reduction was 10.8 ± 6.9 mmHg in the trabeculectomy and 9.3 ± 5.7 mmHg in the canaloplasty group after 2 years (p = 0.47). Mean  IOP  was 11.5 ± 3.4 mmHg in the trabeculectomy and 14.4 ± 4.2 mmHg in the canaloplasty group after 2 years. Following trabeculectomy, complications were more frequent including hypotony (37.5%), choroidal detachment (12.5%) and elevated  IOP  (25.0%).    Conclusions  Trabeculectomy is associated with a stronger  IOP  reduction and less need for medication at the cost of a higher rate of complications. If target pressure is attainable by moderate  IOP  reduction, canaloplasty may be considered for its relative ease of postoperative care and lack of complications.

Trabeculectomy versus canaloplasty ( TVC study) in the treatment of patients with open‐angle glaucoma: a prospective randomized clinical trial