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I MIGS UPDATE N FOCUS 38 | EYEWORLD | JULY 2019 Contact information Ahmed: ikeahmed@mac.com Chang: dceye@earthlink.net Okeke: iglaucoma@gmail.com by Vanessa Caceres EyeWorld Contributing Writer medications after surgery, and more Hydrus subjects were medication-free at 12 months (P=0.0057). When researchers analyzed factors that may affect which eyes were medication-free at 12 months, such as age, ethnicity, or number of baseline medications, the strongest factor they found was treatment with the Hydrus. Lower baseline diurnal IOP and milder visual field severity were also significant predictors of zero medication use at 12 months. Safety was similar in both groups. Two eyes in the Hydrus group and one in the iStent group lost two lines of BCVA. Four cases of IOP elevation greater than 10 mm Hg occurred in the iStent group compared with three cases in the Hydrus group. Device obstruction rates were similar in both groups; obstructions related to iris or tissue adhesions were more common in the iStent group, and peripheral anterior synechiae was the large cause in the Hydrus group. In the iStent group, two eyes had secondary glaucoma surgery performed (3.9%) compared with zero of the Hydrus eyes. No hypotony, device migration, or dislocation occurred in either group. "This is the first study to directly compare the efficacy of different MIGS devices for use in glaucoma management without concurrent cataract surgery," the researchers wrote. Adding to the MIGS evidence Beyond the results themselves, the COMPARE study provides yet more evidence to help comprehensive ophthalmologists in their deci- sion-making, surgeons said. "Having multiple MIGS procedures avail- able to us means that we need better compar- ative data in order to decide which procedure to use and when," said COMPARE co-study author David F. Chang, MD. "For canal-based MIGS procedures, all of the FDA clinical trials compared the stent when used concomitant- ly with phaco to phaco alone. This makes it difficult to compare the relative efficacy of these different devices. The COMPARE trial is therefore important because it is a prospective E ven though the recently published results from the COMPARE trial may not imitate real-life circumstances for cataract and glaucoma surgeons, they still offer clinical pearls and insights. The COMPARE prospective, mul- ticenter, randomized clinical trial pitted the Hydrus Microstent (Ivantis) head-to-head against the use of two iStent Trabecular Micro- Bypass (Glaukos) devices in 152 eyes from 152 patients, 148 of whom completed the study until its 12-month follow up. 1 The goal was to compare the efficacy of the MIGS devices to reduce IOP and medication use among the patients, all of whom had open angle glaucoma. Patients were between 45 and 84 years old, had a Shaffer angle grade of III to IV, a best corrected visual acuity (BCVA) of 20/30 or better, and an IOP of 23 to 39 mm Hg after washout of all hypotensive medications. Patients with angle closure glaucoma, exudative age-related macular degeneration, proliferative diabetic retinopathy, secondary glaucoma except pseudoexfoliation or pigmentary glaucoma, and those at significant risk for secondary glaucoma during the washout period were excluded. Eyes in the study were randomized 1:1 to standalone MIGS with one Hydrus or two iStent devices. However, unlike the "real world," no phacoemulsification was performed. The U.S. FDA approval for both devices currently requires device use combined with phaco. The study's main outcome measures were within-group and between-group differences in IOP and medications at 12 months. Research- ers also considered freedom from any repeat glaucoma surgery, an IOP of 18 mm Hg or less, and no use of glaucoma medications. Safety measures were frequency of surgical complica- tions, visual acuity changes, slit lamp findings, and adverse event rates. The results Both the two iStents and Hydrus were found to lower IOP and medications. The Hydrus had a greater rate of complete surgical success (P<0.001) at 12 months, according to research- ers. Those receiving the Hydrus also used fewer Comparing the COMPARE results to the real world At a glance • Results from the recently published COMPARE trial compared the Hydrus Microstent to the use of two iStent Trabecular Micro-Bypass devices in approximately 150 open angle glaucoma patients. • Both the two iStents and Hydrus lowered IOP and medication use as standalone procedures. More patients in the Hydrus group had reduced medication use or were medi- cation-free at 12 months. • The trial did not include phaco, which is part of the current U.S. FDA approval for the two devices. • A larger number of studies that compare MIGS devices are needed, surgeons think. continued on page 40

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