Implantation of two second-generation trabecular micro-bypass stents and topical travoprost in open-angle glaucoma not controlled on two preoperative medications: 18-month follow-up

Abstract

Importance: Additional data are sought regarding treatment options for glaucoma, a major cause of global blindness. Background: The study assessed outcomes following standalone implantation of two second-generation trabecular micro-bypass stents and postoperative topical prostaglandin in eyes with open-angle glaucoma not controlled on two preoperative medications. Design: The study design is a prospective, nonrandomized, open-label study at a tertiary-care ophthalmology centre. Participants: Subjects had open-angle glaucoma with preoperative intraocular pressure of 18–30 mmHg on two medications, a medication washout phase, and post-washout intraocular pressure of 22–38 mmHg. All subjects (N = 53) have been followed for 18 months. Methods: One day following implantation of two second-generation trabecular micro-bypass stents, subjects started topical travoprost. Medication washout was repeated at month 12. Main Outcome Measures: The main outcome measure was the proportion of eyes with intraocular pressure reduction ≥ 20% versus medicated baseline intraocular pressure with reduction of one medication at 12 months. Results: At 12 months, 91% of eyes achieved intraocular pressure reduction ≥ 20% with reduction of one medication. All eyes had intraocular pressure ≤ 18 mmHg with reduction of one medication, and 87% had intraocular pressure ≤ 15 mmHg. Mean intraocular pressure on one medication was ≤ 13.0 mmHg (≥ 34% reduction) through 18 months. Mean post-washout intraocular pressure at month 13 was 33% lower than preoperative unmedicated intraocular pressure. No adverse events occurred through 18 months. Conclusions and Relevance: In open-angle glaucoma eyes on two preoperative medications, treatment with two second-generation trabecular stents and one postoperative prostaglandin resulted in mean intraocular pressure ≤ 13 mmHg with reduction of one medication, with favourable safety. These findings show the utility of second-generation trabecular bypass with postoperative prostaglandin in patients with open-angle glaucoma.