Prospective randomized controlled trial of phaco-trabectome versus phaco-trabeculectomy in patients with open angle glaucoma

Objective: To compare the efficacy and safety of ab interno trabeculectomy with the Trabectome combined with cataract surgery (phaco-AIT) versus Trabeculectomy with mitomycin C combined with cataract surgery (phaco-Trab) in open-angle glaucoma. Methods: A prospective randomized controlled trial with a single surgeon and surgical center was undertaken. Patients were recruited from July 2009 to October 2014. Primary outcomes were mean intraocular pressure (IOP) at 6 months and surgical complications. Secondary outcomes were mean IOP at 12 months, achievement of target IOP, number of glaucoma medications, and rate of secondary surgery. Results: The trial was ended early before achieving our intended sample size due to difficulties in recruitment and lack of clinical equipoise over time. Nineteen patients were enrolled, 10 phaco-AIT and 9 phaco-Trab. Baseline IOP was 20.0 +/- 5.3 in phaco-AIT and 23.1 +/- 6.4 mm Hg in phaco-Trab (p = 0.22). IOP decreased to 17.5 +/- 3.8 and 16.0 +/- 6.0 mm Hg at 6 months (p = 0.54), and 16.8 +/- 2.7 and 17.1 +/- 5.0 mm Hg at 1 year (p = 0.57), respectively. Mean number of glaucoma medications at baseline was 1.8 +/- 1.3 in phaco-AIT and 1.4 +/- 1.1 in phaco-Trab (p = 0.59). Mean number of glaucoma medications decreased to 0.78 +/- 1.39 and 0.38 +/- 0.74 at 6 months (p = 0.68), and 0.44 +/- 0.88 and 0.75 +/- 0.89 at 1 year (p = 0.41), respectively. Mild and moderate complications were seen in both treatment groups, but severe complications were seen only in phaco-Trab. One secondary glaucoma procedure was required in the phaco-AIT group. Conclusions: Phaco-AIT achieved similar IOP lowering at 6 and 12 months compared with phaco-Trab with a similar number of glaucoma medications required at 1 year, and no serious complications were identified in the Phaco-AIT group.