Adelaide-based Nova Eye Medical has enrolled the first patient in its multicentre study to assess the effectiveness, safety and quality of life outcomes of the canaloplasty procedure using its new iTrack Advance device.
To be conducted across five sites in Germany, the prospective, randomised study, known as CATALYST, will enrol up to 80 patients with mild to moderate, uncontrolled open-angle glaucoma on one to four medications.
Patients will be randomised to treatment with canaloplasty performed in combination with cataract surgery compared to cataract surgery-only.
Key assessment outcomes will include reduction in mean intraocular pressure (IOP) and mean number of glaucoma medications, surgical and postoperative complications, endothelial cell count, and quality of life utilising a patient reported outcome measure.
Professor Norbert Koerber, from Augencentrum Köln-Porz, Köln, Germany, is the primary investigator. An internationally renowned glaucoma surgeon and one of the pioneers of the canaloplasty procedure, Koerber has been performing canaloplasty for nearly two decades.
“I have been a proponent of traditional canaloplasty for many years and continue to offer it to my severe glaucoma patients to push back the need for trabeculotomy or tube shunt surgery. More recently I have adopted canaloplasty via an ab-interno surgical technique in patients with mild-moderate glaucoma,” he said.
“Many of these patients experience unwanted side effects from glaucoma medications or fail to administer their medications as prescribed. For these patients, modern-day canaloplasty, performed via an ab-interno surgical technique, offers an early surgical intervention that acts in a similar way to angioplasty to flush out the eye’s drainage channel and lower IOP, eliminating or reducing the need for medications.”
Nova Eye Medical’s iTrack Advance is cleared for canaloplasty both with and without cataract surgery. However, all canaloplasty procedures in the CATALYST study will be performed in combination with cataract surgery.
“Along with my co-investigator Dr Simon Ondrejka, we have performed more than 20 procedures with the new iTrack Advance device. The major advantage of this new device for the surgeon is that it allows canaloplasty to be a truly single-handed surgical procedure,” Koerber said.
“The handpiece features a custom-designed cannula which enables the surgeon to create an opening in the meshwork, before using the injector on the handpiece to guide the microcatheter easily into the canal – all using only one hand.
“We believe this progress in the device design is a crucial step in encouraging more cataract surgeons to perform ab-interno canaloplasty in combination with cataract surgery. The combined cataract surgery-canaloplasty procedure offers a number of benefits to patients,” he said.
Mr Tom Spurling, managing director of Nova Eye Medical, said the company is pleased to have commenced the study with its latest generation canaloplasty device.
“We are also proud and humbled that, just over 10 years after participating in the 2011 pivotal multicentre study which underpinned market clearance of the traditional (ab-externo) canaloplasty procedure, Professor Koerber will join his German colleagues to further bolster the clinical evidence in support of modern-day canaloplasty, or ab-interno canaloplasty,” Spurling said.
The CATALYST study is expected to reinforce the clinical utility of canaloplasty in the treatment of mild to moderate glaucoma patients.
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