A Manchester research team has treated the first two patients outside of the USA in a study looking at a next generation device for the treatment of glaucoma.
The Department of Eye Research at Manchester Royal Eye Hospital is delighted to have treated the first two European participants on the Summit study.
The Hydrus Microstent – developed by Ivantis, the study sponsor – is a ground-breaking “intracanalicular scaffold” the size of an eyelash.
The study is assessing the 12-month safety and effectiveness of the device in 60 advanced glaucoma patients, for whom conventional therapies to control intraocular pressure have proven unsuccessful.
The Hydrus Microstent has been designed to be less invasive than traditional glaucoma surgery and can be inserted during cataract surgery using the same microsurgical incisions.
The device relieves the high intraocular pressure (IOP) that is common in POAG (Primary Open Angle Glaucoma) patients, who have increased eye pressure because the eye’s fluid channels become blocked.
The tiny Hydrus scaffold is designed to be inserted into the primary fluid canal of the eye and open the channel. It then allows blocked fluid to flow more freely, thereby reducing the high pressure.
The Department of Eye Research is based at Manchester Royal Eye Hospital, part of Manchester University NHS Foundation Trust (MFT). The Chief Investigator for the study is Mr Leon Au, who is based at Manchester Royal Eye Hospital.
The Summit study is on the National Institute for Health Research (NIHR) portfolio and supported at MFT by Clinical Research Network, Greater Manchester.
In total, there are five sites outside of America, including three in Europe, taking part.
Monika Cien, Clinical Trials Manager at the Department of Eye Research, Manchester Royal Eye Hospital, said: “We are proud to have treated the first non-USA patients to this important study which could represent a real development in minimally invasive glaucoma surgery (MIGS).
“The achievement is thanks to the hard work and efficiency of our team, who ensured we were in a position to start recruitment as soon as the study was initiated at the hospital.”
Gretchen Haig, Ivantis Senior Clinical Director in charge of the study, said: “We are thrilled the team at Manchester Royal Eye Hospital has made such a fast start to the Summit study.
“Their department has set a benchmark for sites across Europe to match as we strive towards recruiting 60 patients suitable to be implanted with our ground-breaking Hydrus Microstent, which has already been the subject of a vast body of research.”