Ab-interno canaloplasty is akin to cardiac angioplasty for the eye. Comprising 360° catheterization of Schlemm’s canal followed by the delivery of OVD into the canal via a process of viscodilation, its multimodal mechanism addresses multiple points of blockage in the conventional outflow pathway. This makes it an effective treatment in the majority of my mild-moderate open-angle glaucoma patients…
Titled “MAGIC” – Multi-center Ab‑interno Glaucoma study Investigating Canaloplasty (NCT04769453) – the single-masked 2×2 factorial trial will assess a number of factors that impact the clinical outcomes of ab-interno canaloplasty, including a comparison of the iTrack™ canaloplasty microcatheter (Nova Eye Medical) with the OMNI® surgical system (Sight Sciences). The clinical impact of the type of ophthalmic viscosurgical device (OVD) used during the procedure, and the volume of OVD delivered, will also be assessed.
The MAGIC Trial will be performed over a 12-month period and will enrol up to 160 patients with mild to moderate, uncontrolled primary open-angle glaucoma (POAG) on 1 – 4 medications. Patients will be randomized to the iTrack™ and OMNI® treatment groups respectively. Primary endpoints will include reduction in mean IOP and mean number of anti-glaucoma medications. Secondary endpoints will include surgical and postoperative complications. Ab-interno canaloplasty will be performed as a standalone procedure during the MAGIC Trial, to eliminate the confounding effect of cataract surgery.
|TRIAL DESIGN||Prospective, multi-center, randomized, single-masked 2×2 factorial clinical trial with follow-up through 12 months|
|PATIENT POPULATION||Up to 78 eyes per arm of 156 qualified subjects|
|RANDOMIZATION||Participants will be randomized 1:1:1:1 into one of the four groups|
|(1) OMNI + Healon GV Pro|
|(2) OMNI + Healon Pro|
|(3) iTrack + Healon GV Pro|
|(4) iTrack + Healon Pro|
|PRIMARY ENDPOINTS||Change in mean Intraocular Pressure (IOP) and Medication use at 12 months compared to baseline|
|SECONDARY ENDPOINTS||Complications/adverse events associated with iTrack and OMNI, Healon Pro and Healon GV Pro respectively and visual acuity at 12 months|
|STUDY SITES||8 investigational sites in the USA|
ABOUT THE MAGIC STUDY INVESTIGATORS
Eye Physicians & Surgeons of Arizona, Arizona (USA)
Dr. Patel is in private practice at Eye Physician & Surgeons of Arizona. A fellowship-trained glaucoma and cataract surgeon, he specializes in medical and surgical glaucoma and modern cataract surgery methods. Dr. Patel is affiliated with St. Joseph’s Hospital and Medical Center.
Dean McGee Eye Institute, University of Oklahoma, Oklahoma City (USA)
Dr. Khaimi is a Clinical Professor at the Dean McGee Eye Institute, University of Oklahoma. His special interests include minimally invasive glaucoma surgery (MIGS), filtration and glaucoma drainage surgery for glaucoma, and complex cataracts. Dr. Khaimi was one of the first adopters of traditional ab-externo canaloplasty, having performed more than 1000 procedures. More recently, he has pioneered the MIGS procedure ab-interno canaloplasty. Dr. Khaimi was previously the primary investigator for the ‘Primary Trabeculectomy versus Tube’ study. He has been co-investigator for the Express mini shunt versus Trabeculectomy (XVT) study, the COMPASS study, and the Ologen versus Mitomycin C study.
El Paso Eye Surgeons, Texas (USA)
Dr. Gallardo is in private practice at El Paso Eye Surgeons. He has worked in ophthalmology for nearly 20 years and currently is affiliated with Hospitals of Providence Sierra Campus, Las Palmas Medical Center and University Medical Center of El Paso. His glaucoma expertise extends across the entire MIGS treatment armamentarium. Dr. Gallardo recently completed a 36-month review of ab-interno canaloplasty in POAG patients. He performs ab-interno canaloplasty across the entire glaucoma diseases process, including cases of severe glaucoma, and as both a stand-alone and combined procedure.In addition to his pioneering work with ab-interno canaloplasty, Dr. Gallardo is a study investigator for several MIGS-related studies, including iStent (Glaukos), Hydrus (Ivantis) and Kahook Dual Blade (New World Medical).
OCLI Vision, Connecticut (USA)
Dr. Robert J. Noecker is in private practice at OCLI Vision and specializes in the medical, laser and surgical management of glaucoma and cataracts, including MIGS procedures and femto-laser assisted surgery. Dr. Noecker did his undergraduate work in engineering at MIT, medical school at the University of North Carolina in Chapel Hill, residency in Ophthalmology at the University of Arizona and Fellowship in glaucoma at Tufts University in Boston. He is currently an Assistant Professor of Ophthalmology at Yale University School of Medicine and Professor of Surgery at the Frank Netter School of Medicine of Quinnipiac University.
Eye Physicians & Surgeons of Arizona, Arizona (USA)
Dr. Reiss is in private practice at Eye Physician & Surgeons of Arizona and has extensive experience with advanced cataract surgery techniques. Dr. Reiss is a long-standing clinical research investigator for emerging glaucoma devices and medications. His medical background includes receiving his Medical Doctor degree from the State University of New York with an internship at Winthrop University Hospital in Mineola, NY, and residency at the Mayo Clinic in Rochester, Minnesota. Dr. Reiss received his glaucoma fellowship training at the University of Illinois Eye Center in Chicago.
Cataract & Laser Institute, Oregon (USA)
Dr. Spaulding is a glaucoma specialist at the Cataract & Laser Institute in Orgeon. He is also an osteopathic physician. He has a special interest in minimally invasive glaucoma surgery (MIGS) combined with cataract surgery, and refractive cataract surgery with premium lenses. He undertook his glaucoma fellowship at the Dean McGee Eye Institute, University of Oklahoma. Before his medical career he served as a firefighter with the US Forest Service.
Coastal Vision, California (USA)
Dr. Tran is in private practice at Coastal Vision, California. His education and experience encompasses both engineering and medicine. The first surgeon in the world to use an IntraLase laser to perform All-Laser LASIK procedures, Dr. Tran has trialled many innovative technologies which have today become accepted as standard of care.
The Eye Centers of Racine & Kenosha, Wisconsin (USA)
Dr. Singh is a glaucoma specialist in private practice at The Eye Centers of Racine & Kenosha and has extensive expertise across the entire MIGS treatment armamentarium. He completed his fellowship in Glaucoma at Duke University in July 2004, his residency at Cook County Hospital – Division of Ophthalmology, and his internship at Michael Reese Hospital – Department of Medicine, both in Chicago, Illinois. Dr Singh is on the Board of Directors for The Glaucoma Forum and serve on the editorial boards for the journals Glaucoma Today and Glaucoma Physician. Dr. Singh is a study investigator for several MIGS-related studies, including Glaukos), Ivantis and New World Medical.
Beverly Hills Institute of Ophthalmology, California (USA)
Dr. Billy Pan is in private practice at the Beverly Hills Institute of Ophthalmology. He obtained both his Bachelor of Science and Doctor of Medicine degrees from the University of Southern California (USC). During medical school, he was inducted into Alpha Omega Alpha, the medical honor society, and awarded the Order of Areté – the highest honor accorded to graduate students of USC. He then went on to pursue his ophthalmology residency at Los Angeles County, University of Southern California (LAC-USC) / Roski Eye Institute. After residency, he undertook a glaucoma fellowship with Dr. Louis Pasquale at the Massachusetts Eye and Ear Infirmary at Harvard Medical School where he was named the Richard J. Simmons and Ruthanne B. Simmons Glaucoma Fellow.
Arbor Eye Centers for EyeCare, Chicago (USA)
Dr. David Lubeck is a founder and world-renowned surgeon at Arbor Centers for EyeCare, specializing in cataract, cornea and refractive surgery. He is Assistant Clinical Professor of Ophthalmology at the University of Illinois, Chicago and lectures regularly. Dr. Lubeck has developed curricula that have been integrated into surgical teaching programs across the USA and abroad. He has hosted and participated in live surgery programs in China, India, Vietnam, Korea, Australia, the Philippines, and the USA.
Along with the other trial investigators, I am of the strong opinion that the removal of tissue should be avoided in the treatment of mild-moderate glaucoma patients, where possible. We know that glaucoma is a multifactorial disease. I want to preserve the trabecular meshwork tissue to leave us with the option to treat the patient’s drainage system again, depending on how their disease progresses.
The iTrack™ canaloplasty microcatheter has been cleared for the indication of fluid infusion and aspiration during surgery, and for catheterization and viscodilation of Schlemm’s canal to reduce intraocular pressure in adult patients with open-angle glaucoma.