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Thursday / May 30.
HomeminewsiTrack Advance CATALYST Study Launched

iTrack Advance CATALYST Study Launched

The first patient has been enrolled in a prospective, randomised, multicentre study to investigate canaloplasty with the new iTrack Advance CATALYST Study.

Dr Ondrejka (right) performs a canaloplasty procedure with the new iTrack Advance device. During the withdrawal of the microcatheter, the scrub nurse (left) titrates the ViscoInjector viscoelastic delivery device to deliver a custom volume of OVD, based on the patient’s pathology.

To be conducted across five sites in Germany, CATALYST will assess the effectiveness, safety and quality of life (QoL) outcomes of the canaloplasty procedure using the Company’s new iTrack Advance device. The multicentre study 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 (‘Canaloplasty Group’) compared to cataract surgery-only (‘Control Group’).

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 QoL using a patient reported outcome measure.

Prof. Dr. med. Norbert Koerber, FEBO, Augencentrum Köln-Porz, Köln, Germany, will assume the role of Primary Investigator for the CATALYST Study.

An internationally renowned glaucoma surgeon and one of the pioneers of the canaloplasty procedure, Prof. 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. 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.”

Dr Ondrejka with the new iTrack Advance device, which features a proprietary illuminated tip that enables the surgeon to visualize the microcatheter through every procedural step.

The iTrack Advance is cleared for canaloplasty both with and without cataract surgery. All canaloplasty procedures in the CATALYST Study will be performed in combination with cataract surgery, however.

“Along with my co-investigator 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. 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,” commented Prof. Dr. med. Koerber.

Tom Spurling, Managing Director of Nova Eye Medical, said, “We are pleased to have commenced this important European study with our latest generation canaloplasty device iTrack Advance. We are also proud and humbled that, just over 10 years after participating in the 2011 pivotal multi-centre 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.”

The CATALYST Study is expected to reinforce the clinical utility of canaloplasty in the treatment of mild to moderate glaucoma patients.