Nova Eye Medical Announces Global Data Registry to Support Role of Canaloplasty for Glaucoma
Nova Eye Medical announced the establishment of the iTrack Global Data Registry to collect prospective, multicenter, longitudinal data for canaloplasty in the treatment of glaucoma.
A collaboration with the International Glaucoma Surgery Registry (IGSR), the iTrack Global Data Registry will be led by world-renowned surgeons Iqbal Ike K. Ahmed, MD, FRCSC, (John A. Moran Eye Center, Utah, USA and Prism Eye Institute, Toronto, Canada); David Lubeck, MD, (Arbor Centers for EyeCare, Chicago, USA); and Nathan Kerr, BHB, MBChB, MD, FRANZCO (Eye Surgery Associates, Melbourne, Australia), with the support of an educational grant from Nova Eye Medical.
The iTrack Global Data Registry will capture real-world clinical evidence for canaloplasty across Europe, the Asia Pacific, and North America. The company’s portfolio of proprietary canaloplasty devices – the iTrack and iTrack Advance – will feature in the Registry.
Dr. Kerr is one of the founders of the IGSR and has spearheaded the development of the iTrack Global Data Registry. He will present an interim data analysis for the iTrack Global Data Registry during the Asia Pacific Glaucoma Congress (APGC), August 4-7, 2022, in Malaysia.
“The iTrack Global Data Registry is providing high-quality, real-world evidence of the effectiveness and safety of canaloplasty to treat glaucoma and ocular hypertension. Importantly, it provides a robust means by which to collect uniform data to evaluate specified outcomes across the spectrum of glaucoma. It will make a major contribution to our understanding of the clinical effectiveness of canaloplasty and will enable evidence-based decision making,” Dr. Kerr said in a Nova Eye Medical news release.
According to Dr. Lubeck, the Registry will ensure the fullest utilization of canaloplasty in daily clinical practice.
“Despite 14 years and tens of thousands of procedures performed globally there is still much to be learned about the nuances and versatility of the canaloplasty procedure. The Registry will address key treatment parameters such as patient specific needs, preferences, type of glaucoma, disease stage and tolerance to prior treatment. The data collected will help guide surgeon decision-making when planning surgery for their glaucoma patients, said Dr. Lubeck.
According to Dr. Ahmed, the Registry will help surgeons determine when, and how, to use canaloplasty in clinical practice.
“The emergence of new treatment options for glaucoma, including MIGS, and the possibility to intervene earlier in the treatment paradigm is a huge win for both patients and surgeons. With the increased array of available treatment options, however, there is a need to better understand when and how these treatments should be utilized. With the data to be generated by the Registry my hope is that we can build an algorithm to inform on the utilization of canaloplasty," Dr. Ahmed said.
“We have provided support for the IGSR to accommodate the necessary canaloplasty data but will not be involved in the management of the Registry data," Tom Spurling, Managing Director of Nova Eye Medical, said in the news release. "The Registry provides surgeons with a platform through which they can independently document their canaloplasty outcomes. Right from the outset, it was very important that the Registry be surgeon driven. We are grateful for the active commitment, self-direction, and follow-through of all participating surgeons, especially doctors Lubeck, Ahmed and Kerr.”
The iTrack Global Data Registry will follow canaloplasty outcomes for a minimum of 24 months and will enrol more than 300 patients.
IRB Approval information:
- WCG IRB (approval number)- 20200728
- Australian New Zealand Clinical Trials Registry (ACTRN trial number 12620001021965)