Purpose: To compare differences in medication required to maintain intraocular pressure (IOP) in open angle glaucoma (OAG) for two microinvasive glaucoma surgery (MIGS) devices.
Setting: The study recruited volunteers from 12 clin- ical practices located in 9 countries in Europe, South America, Asia, and the Middle East with open angle glaucoma. Local ethics committee approval was obtained at all sites.
Methods: This was a prospective, multi-centre ran- domized clinical trial. 152 eyes on ≥2 hypotensive medications and washed out diurnal IOP between 23-39 mm Hg were randomized 1:1 on the day of surgery to either single Hydrus Microstent (Ivantis, Irvine, CA) or two GTS100 iStent Trabecular Micro- Bypass Stents (Glaukos, San Clemente, CA) . There was no concomitant cataract surgery. Follow up was conducted at 1, 3, 6, and 12 months postoperative.
Results: Matched Hydrus Microstent (HMS) and
2 iStent (2IS). At 12M, the proportion of patients with 1 or more glaucoma medications reduced and a 20% or more reduction in IOP was 82.2% and 61.3% for HMS and 2IS, respectively (P = 0.0061). The mean change in medications at 12 months was
−1.6 1.2 in the HMS group vs −1.0 1.2for the 2IS group (P < 0.001 vs baseline, difference in change = −0.6 medications, P = 0.004). Conclusion: Both MIGS devices reduced medica- tion count at 12 months. The medication reduction in the HMS group was signiﬁcantly greater than in the 2IS group, deﬁned as reduction of 31 medication and 320% reduction in IOP.
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