Q&A: Registry focuses on long-term iTrack, iTrack Advance canaloplasty data
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With support from Nova Eye Medical, a group of surgeons has launched a registry that will capture real-world data on canaloplasty procedures performed with the iTrack and iTrack Advance devices.
The group is led by canaloplasty surgeons David Lubeck, MD, of the United States, Nathan Kerr, BHB, MBChB, MD, FRANZCO, of Australia, and Ike Ahmed, MD, FRCSC, of Canada.
Source: Adobe Stock.
The registry will be housed within the International Glaucoma Surgery Registry and will follow canaloplasty outcomes for a minimum of 24 months.
Healio/OSN spoke with Lubeck regarding the registry and how it is expected to help inform surgeon decision-making in the future.
Healio/OSN: What are the iTrack and iTrack Advance, and what makes them unique as MIGS devices?
Lubeck: Canaloplasty with the iTrack is a unique procedure in that it is the only MIGS surgery that is nondestructive, does not leave an implant or any other foreign body in the eye, and uses pressurized viscodilation to increase facility of outflow through the trabecular meshwork, Schlemm’s canal and distal outflow system.
Healio/OSN: What are the long-term goals for the new registry, and what do you hope to learn?
Lubeck: Canaloplasty with iTrack has been performed for many years and tens of thousands of times, but there has never been a pivotal or large-number study to validate its efficacy and safety. In the world of ophthalmology, it has been hard to attract the attention of a larger population of surgeons and to get validation from insurance companies, as well as from glaucoma and medical societies. The registry project is intended to capture clinical and surgical data from a large number of patients in a relatively short period of time.
The goal is to enroll between 600 and 1,000 patients in the first year. Presently, it is recruiting from 20 sites in three continents, Australia, the United States and Europe. Asian surgeons will likely begin enrolling by the end of the year. The data sets will be comprehensive and include diverse patient populations. Surgical data being captured will include incision parameters for iTrack access, the type of viscoelastic used and the amount delivered during the procedure. A detailed risk and complication profile including endothelial cell loss will be generated.
Healio/OSN: You mentioned it can be difficult to attract new surgeons to the procedure. How would you pitch canaloplasty with iTrack to a colleague?
Lubeck: My call to surgeons is that if they have not looked at canaloplasty, they are missing an opportunity to do a nondestructive, non-stent procedure improving outflow through all segments of the conventional outflow system that can be performed in patients with all grades of glaucoma. That includes mild to severe and in combination with cataract surgery or as a stand-alone procedure. It fills a void between medical/laser treatment and filtration surgery. This procedure often can lower pressure and reduce medication burden to a point that filtration or cyclodestructive surgery is not needed.
The original technique of the canaloplasty procedure has a legacy of being more technically difficult to perform. The utility of iTrack canaloplasty is still significant, and new iterations of the surgery make it more approachable. The next-generation delivery system, iTrack Advance, currently available in Europe and Canada, will make the procedure even more efficient. It can be hard to bring people back to something that they have not made part of their routine practice, but surgeons need to dismiss their prior misconceptions and reconsider iTrack canaloplasty in their glaucoma treatment regimen.
For more information:
David Lubeck, MD, can be reached at email: dr.lubeck@arboreyecare.com.
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