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PURPOSE: To evaluate the long-term intraocular pressure (IOP)-lowering effect and safety parameters following treatment with two trabecular micro-bypass stents and topical prostaglandin in phakic eyes with open-angle glaucoma (OAG) not controlled on two preoperative medications. METHODS: This prospective, single-arm, unmasked study enrolled 39 qualified phakic eyes with OAG not controlled on 2 medications, preoperative medicated IOP of 18-30 mmHg, and IOP following medication washout of 22-38 mmHg. Two trabecular micro-bypass stents were implanted as a standalone procedure, and travoprost was started on postoperative day 1. Evaluations included IOP, best-corrected visual acuity, medication use, fundus and slit-lamp examinations, visual field, cup:disc ratio, central corneal thickness, and ocular complications. Data through 18 months were summarized previously. Thirty-seven of the original 39 subjects have been followed for 3 years postoperatively; follow-up is continuing for 5 years. RESULTS: At 3 years postoperative, 97% of eyes had achieved an IOP reduction of ≥20% from baseline with a reduction of 1 medication. Eighty-six percent of eyes had IOP of ≤18 mmHg with a reduction of 1 medication. Mean medicated IOP decreased to 14.0±2.6 mmHg on 1 medication versus 22.4±2.3 mmHg on 2 medications preoperatively. The mean unmedicated IOP decreased to 17.7±1.7 mmHg at 37 months from 25.3±1.9 mmHg preoperatively. Long-term postoperative adverse events included cataract surgery in 3 eyes due to cataract progression, and trabeculectomy in 1 eye due to uncontrolled IOP of 23 mmHg. No intraoperative or device-related adverse events occurred. CONCLUSION: Significant and sustained reduction in IOP and medications with a favorable safety profile was shown through 3 years after implantation of 2 trabecular micro-bypass stents combined with postoperative travoprost in phakic OAG eyes uncontrolled on 2 preoperative medications. These findings demonstrate the long-term performance and safety of trabecular bypass stents in combination with topical prostaglandin for OAG patients.
Altos Eye Physicians, Los Altos, CA.
Full article12.8.2 With tube implant or other drainage devices (Part of: 12 Surgical treatment > 12.8 Filtering surgery)
11.4 Prostaglandins (Part of: 11 Medical treatment)