Long-Term Outcomes of MIGS With Trabecular Micro-Bypass Stents and Prostaglandin in Open-Angle Glaucoma
Narrative Responses:
Purpose
To report long-term outcomes from a prospective study by the MIGS study group, consisting of implantation of two stents as the sole surgical procedure followed by one postoperative medication, in eyes with OAG previously not controlled with two medications.
Methods
Phakic or pseudophakic subjects on two ocular hypotensive medications, with medicated IOP ≥ 18 mmHg and ≤ 30 mmHg, and unmedicated (post-washout) IOP ≥ 22 mmHg and ≤ 38 mmHg were enrolled. Thirty-nine qualified subjects received two stents (Glaukos) through a 1 mm clear corneal incision, followed by postoperatively prescribed travoprost. IOP, fundus/optic nerve exam, slit-lamp, gonioscopy, surgical/postoperative complications and best corrected visual acuity were assessed. Efficacy endpoints at Month 12 included IOP reduction ≥ 20% vs. baseline with reduction of one medication, and IOP ≤ 18 mmHg with reduction of one medications. Safety assessment through 60 months is ongoing.
Results
Current data are available through 18 months. Average age was 64 ± 12 years; 88% of eyes were phakic. Mean IOP was 22.3 ± 2.5 mmHg before medication washout, and 25.1 ± 1.9 mmHg after washout. One subject experienced transient hypotony at one week; this resolved without intervention or further sequelae by one month. No other complications were reported. All eyes achieved Month 12 IOP reduction ≥ 20% vs. baseline, and Month 12 IOP ≤ 18 mmHg, with reduction of one medication. Month 18 mean IOP was 11.8 ± 2.5 mmHg, a decrease from preoperative medicated IOP of 10.5 mmHg.
Conclusion
Significant IOP and medication reduction through 18 months postoperative was achieved in phakic or pseudophakic OAG subjects not controlled on two preoperative medications. Results through two years postoperative will be reported.