Hydrus plus cataract surgery maintains decreased IOP without medications

Furthermore, it is the first MIGS randomized controlled trial to report the effect of a glaucoma device using a “terminal washout” protocol, thus removing the confounding effects of glaucoma medications, Thomas W. Samuelson, MD, said at the annual meeting of the American Glaucoma Society.

“A really import effort was made to minimize bias,” Samuelson said. “Diurnal IOP measurements were performed following a medication washout protocol at baseline and again at annual visits, patients were subject to randomization at the time of surgery using a computer-generated list, and investigators followed a protocol that required adding back medications if the pressures were above 19 mm Hg.”

The Hydrus II trial is a European study comparing the Hydrus device (Ivantis) plus cataract surgery with cataract surgery alone for the reduction of IOP in open-angle glaucoma; the equivalent clinical trial in the U.S. is the Hydrus IV trial.

In this multicenter trial, 100 eyes were randomized to either phacoemulsification plus the Hydrus device or phacoemulsification only. At 24 months, 73% of Hydrus patients were medication-free vs. 38% of phaco-only patients (P = .0008). Among patients whose IOP decreased 20% after the surgery, 88% in the Hydrus arm maintained the decrease at 12 months vs. 74% in the control arm. At 24 months, the rate was 80% in the Hydrus arm and 46% in the control arm.

This endpoint of maintaining a 20% decrease in IOP after washout is similarly being used in other ongoing MIGS clinical trials, Samuelson said. – by Patricia Nale, ELS

Disclosure: Samuelson reports financial relationships with Aerie, Alcon, Abbott Medical Optics, AqueSys, Acumems, Endo Optiks, ForSight Labs, Glaukos, Ivantis, Inotek, Omeros, Ono, Santen, Transcend and Vindico/SLACK Incorporated.