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

Abstract

ObjectiveTo 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. MethodsA 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. ResultsThe 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. ConclusionsPhaco-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.