RESUMEN
PURPOSE: Compare 12-month (12 M) safety and efficacy of endoscopic cyclophotocoagulation (ECP) + cataract surgery (Group 1) versus ECP + cataract surgery + iStent inject trabecular micro-bypass implantation (Group 2) in Brazilian patients with open-angle glaucoma (OAG). METHODS: This prospective, multicenter, comparative case series included patients with OAG and cataract who were randomized to receive treatment in Group 1 or Group 2. Outcomes included mean and percent reduction versus preoperative in intraocular pressure (IOP) and number of glaucoma medications; visual acuity; occurrence of adverse events; and rate of secondary surgeries. RESULTS: Preoperatively, Groups 1 and 2 had similar mean IOP (mean ± standard deviation 22.1 ± 3.6 and 22.0 ± 2.5 mmHg, respectively) and mean number of medications (3.3 ± 0.6 and 3.4 ± 0.6 medications, respectively). At all follow-up timepoints through 12 M, both groups achieved significant IOP and medication reductions versus preoperative (IOP p < 0.001 and number of medications p < 0.001 for both groups). At 12 M, IOP reductions were 24.2% (Group 1) and 43.6% (Group 2) (p < 0.001); mean medication reductions were 50.2% and 71.5%, respectively. Mean postoperative IOP and number of medications were higher in Group 1 than Group 2 (IOP p < 0.01 all visits, medication p < 0.01 at 6 M and 12 M). Adverse events were generally mild and infrequent in both groups. CONCLUSION: Both treatment groups (ECP + phacoemulsification, with/without iStent inject implantation) achieved significant and safe reductions in IOP and medications versus preoperative in Brazilian OAG patients. Percent reductions were significantly greater, and mean IOP and medications were significantly lower, in the group receiving iStent inject. CLINICAL TRIAL REGISTRATION (CTR): CAAE project identification #20053019.5.0000.5078. Protocol #3.587.147. Clinical Trial Database of the Federal University of Goiás, Brazil. Registration Date: September 19, 2019.