First patient enrolled in stand-alone Hydrus microstent trial
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The first patient has been enrolled in a trial investigating the stand-alone use of the Hydrus microstent in mild to moderate open-angle glaucoma, according to a press release from Ivantis.
The FRONTIER pivotal clinical trial will investigate the effectiveness of the Hydrus microstent in patients who have already had cataract surgery. In the HORIZON pivotal trial, patients who received the microstent and underwent cataract surgery at the same time had a reduction in visual field loss and were less likely to require medications or additional surgeries after 5 years.
“With the FRONTIER trial, we are embarking on an exciting opportunity to change the course of the disease in the U.S., offering hope for thousands of glaucoma patients and the practitioners who care for them,” Dave Van Meter, president and CEO of Ivantis, said in the release. The microstent is often implanted without cataract surgery outside of the U.S.
The trial will evaluate 234 eyes that will receive the Hydrus microstent after cataract surgery. Patients must have had no complications during cataract surgery and not undergone MIGS, cilioablation or incisional glaucoma surgery. Co-primary effectiveness endpoints are the proportion of subjects with a 20% or greater unmedicated diurnal IOP reduction at 12 months compared with baseline and the mean change in unmedicated diurnal IOP at 12 months compared with baseline.
The device received FDA approval for use with cataract surgery in 2018.
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