EyeWorld Asia-Pacific September 2019 Issue
32 EWAP SEPTEMBER 2019 SECONDARY FEATURE 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, multicenter, 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 Ü>Ã Ì V«>Ài Ì
i ivwV>VÞ v 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 >}i }À>`i v Ì 6] > LiÃÌ VÀÀiVÌi` ÛÃÕ> >VÕÌÞ 6Ƃ® v 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 Ã}wV>Ì ÀÃ vÀ ÃiV`>ÀÞ 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 «
>ViÕÃwV>Ì Ü>Ã 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. Researchers 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 complications, visual >VÕÌÞ V
>}iÃ] ÃÌ >« w`}Ã] 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 researchers. Those receiving the Hydrus also used fewer 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 ÛÃÕ> wi` ÃiÛiÀÌÞ ÜiÀi >à Ã}wV>Ì «Ài`VÌÀà v âiÀ medication use at 12 months. Safety was similar in both groups. Two eyes in the Hydrus group and one in the iStent }ÀÕ« ÃÌ ÌÜ ià v 6Ƃ° Four cases of IOP elevation greater than 10 mmHg 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. º/
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i ivwV>VÞ v different MIGS devices for use in by Vanessa Caceres EyeWorld Contributing Writer 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 medication-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. Comparing the COMPARE results to the real world Contact information Ahmed: ikeahmed@mac.com Chang: dceye@earthlink.net Okeke: iglaucoma@gmail.com Hydrus This article originally appeared in the July 2019 issue of EyeWorld . It has been UNKIJVN[ OQFKƂGF CPF CRRGCTU JGTG YKVJ permission from the ASCRS Ophthalmic Services Corp.
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