Back in June of this year we covered the FDA’s approval of the first glaucoma stent, the so-called i-Stent. That device was indicated for use in combination with cataract surgery to reduce intraocular pressure in adult patients with mild or moderate open-angle glaucoma and a cataract who are currently being treated with medication to reduce intraocular pressure.
Now clinical trial results have been released which suggest another such device can successfully control eye pressure a year after implantation.
Open-angle glaucoma, the most common form of the disease, affects nearly three million people in the U.S and 60 million worldwide. Currently the only proven way to prevent vision loss is by reducing intraocular pressure (IOP). The treatment choices are effective but less than ideal, as some patients may not use eye drop medications consistently enough to control their IOP, while others may not respond to the drugs.
Surgical procedures to open blocked drainage channels or implant larger stents, which are used only for patients with advanced glaucoma, carry risks of infection, bleeding, deterioration of other parts of the eye, and vision loss.
So to these so-called glaucoma stents, which work by providing a new drainage channel for the eye’s aqueous fluid, circumventing the patient’s own clogged or blocked channels. The Hydrus stent, manufactured by Californian company Ivantis Inc., is no larger than an eyelash, yet may significantly reduce eye pressure in glaucoma patients and allow some to stop using eye-drop medications, according to year-one clinical trial results for the device.
Results of the HYDRUS I clinical trial, which indicate successful control of eye pressure in all study participants, was presented at this week’s 116th Annual Meeting of the American Academy of Ophthalmology. 69 patients suffering mild to moderate open-angle glaucoma demonstrated reduction in IOP to acceptable levels in 100 percent of participants after they received minimally invasive stent implant surgery. At the six-month follow up, 85 percent of combined surgery and 70 percent of stent-only patients no longer needed eye drop medications to control their IOP.
Reductions in IOP were consistent among all patients and remained stable at the one year follow up.
“So far, mini-stents appear to have important advantages in that they allow us to treat open-angle glaucoma at earlier stages and with lower complication risk,” said Thomas W. Samuelson, M.D., a glaucoma specialist with Minnesota Eye Consultants, who served as the HYDRUS I trial’s medical monitor. “If the devices can effectively control IOP over many years, it would be a real breakthrough in combating this blinding disease.”
The Hydrus Microstent is available on an investigational only basis in the United States.
Source: This feature is extracted from an item published on medicalxpress.com, itself based on an article provided by American Academy of Ophthalmology