LAUSR

OBJECTIVE To compare the efficacy of different MIGS devices for reducing intraocular pressure (IOP) and medications in open-angle glaucoma (OAG). DESIGN Prospective, multicenter, randomized clinical trial. STUDY PARTICIPANTS 152 eyes from 152 patients aged 45-84 years with OAG, Shaffer angle grade III-IV, BCVA 20/30 or better, and IOP 23-39 mmHg after wash out of all hypotensive medications. Eyes with secondary glaucoma other than pseudoexfoliative or pigmentary glaucoma, angle closure, previous incisional glaucoma surgery, or any significant ocular pathology other than glaucoma were excluded. INTERVENTION Study eyes were randomized 1:1 to standalone microinvasive glaucoma surgery (MIGS) consisting of either one Hydrus® Microstent (Ivantis, Inc., Irvine, CA) or two iStent® Trabecular Micro Bypass devices (Glaukos Inc., San Clemente CA). Follow-up was performed 1 day, 1 week, and 1, 3, 6, and 12 months postoperative. MAIN OUTCOME MEASURES Within-group and between-group differences in IOP and medications at 12 months and complete surgical success rates, defined as freedom from repeat glaucoma surgery, IOP 18 mmHg or less, and no glaucoma medicatios. Safety measures included the frequency of surgical complications, changes in visual acuity, slit lamp findings, and adverse event rates. RESULTS Study groups were well matched for baseline demographics, glaucoma status, medication use and baseline IOP. Twelve month follow up was completed in 148/152 randomized subjects (97.3%). At 12 months, the Hydrus had a greater rate of complete surgical success (p<0.001) and reduced medication use (difference = -0.6 medications, p=0.004). More Hydrus subjects were medication free at 12 months (difference = 22.6% p=0.0057). Secondary glaucoma surgery was performed in 2 eyes in the 2 iStents group (3.9%) and in none of the Hydrus eyes. Two eyes in the Hydrus group and 1 in the 2 iStent group had BCVA loss of 2 lines. CONCLUSION Standalone MIGS in open angle glaucoma with the Hydrus resulted in a higher surgical success rate and fewer medications compared to the 2 iStent procedure. The two MIGS devices have similar safety profiles.