A Multicenter Prospective Comparative Study Evaluating Cataract Surgery and Endoscopic Cyclophotocoagulation either with or without iStent inject Implantation in Brazilian Patients with Glaucoma

Purpose: Compare 12-month (12M) 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 intraocular pressure (IOP); number of glaucoma medications; visual acuity; adverse events; and secondary surgeries. Results Preoperatively, Groups 1 and 2 had similar mean IOP (22.1 and 22.0 mmHg, respectively) and medication burden (3.3 and 3.4 medications, respectively). At all follow-up timepoints through 12M, both groups achieved significant IOP and medication reductions versus preoperative (IOP p < 0.001 and meds p < 0.001 for both groups). At 12M, IOP reductions were 24.2% (Group 1) and 43.6% (Group 2) (p < 0.001); medication reductions were 50.2% and 71.5%, respectively. Mean postoperative IOP and medications were higher in Group 1 than Group 2 (IOP p < 0.01 all visits, medication p < 0.01 at 6M and 12M). Adverse events were generally mild and infrequent in both groups. Conclusion In this prospective comparative study of ECP + phacoemulsification, either with/without iStent inject implantation, both treatment groups achieved significant and safe reductions in IOP and medications versus preoperative in Brazilian OAG patients. Reductions were significantly greater, and mean postoperative IOP and medications were significantly lower, in the group receiving iStent inject with ECP and phacoemulsification.