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.

Ab interno trabeculectomy: outcomes in exfoliation versus primary open-angle glaucoma.

PURPOSE: To compare outcomes in exfoliation glaucoma versus primary open-angle glaucoma (POAG) after ab interno trabeculectomy alone (Trabectome) or in combination with cataract surgery and intraocular lens (IOL) implantation. SETTING: Trabectome Study Group institutions. DESIGN: Prospective nonrandomized cohort study. METHODS: Outcomes included intraocular pressure (IOP), glaucoma medications, complications, secondary procedures, and success, defined as no secondary surgery and IOP less than 21 mm Hg and a greater than 20% reduction from baseline. RESULTS: In the ab interno trabeculectomy-alone group, the mean preoperative IOP was 29.0 mm Hg ± 7.5 (SD) in exfoliation glaucoma cases and 25.5 ± 7.9 mm Hg in POAG cases (P<.01). At 1 year, the mean decrease in IOP was -12.3 ± 8.0 mm Hg and -7.5 ± 7.4 mm Hg, respectively (P<.01); the secondary procedure rate was 20.9% and 34.9%, respectively (P=.02); and the cumulative probability of success was 79.1% and 62.9%, respectively (P=.004). In the combined ab interno trabeculectomy-IOL group, the mean preoperative IOP was 21.7 ± 8.4 in exfoliation glaucoma cases and 19.9 ± 5.4 mm Hg in POAG cases (P=.06). At 1 year, the mean decrease in IOP was -7.2 ± 7.7 and -4.1 ± 4.6, respectively (P<.01); the secondary procedure rate was 6.7% and 6.1%, respectively (P=.88); and the cumulative probability of success was 86.7% and 91.0% (P=.73), respectively. CONCLUSION: Ab interno trabeculectomy using this new incisional procedure safely lowered IOP to the mid teens, with an overall greater reduction in exfoliation glaucoma and improved success when combined with cataract surgery.