Sight Sciences announced that positive outcomes from a new multicenter study of one of the OMNI Surgical System’s predecessor devices, TRAB360, were published in the American Journal of Ophthalmology.
Following a 2019 publication1 of a clinical study which evaluated the safety and effectiveness of circumferential ab interno trabeculotomy (goniotomy) using TRAB360 in standalone MIGS surgery in adults, this study is the first multicenter trial to evaluate the same procedure performed in pediatric patients.
The study, titled “Trabeculotomy Ab Interno with the TRAB360 Device for Childhood Glaucomas,”2 is a multicenter, retrospective interventional case series of 46 eyes in 41 patients with a median age of 12 months and a median follow-up period of 14.5 months. Median preoperative IOP was 30 mm Hg and median post-operative IOP was 18 mm Hg from this standalone pediatric surgery at the median follow-up period of 14.5 months. Surgical success, defined as postoperative IOP of ≤24 mm Hg with or without medications and no additional surgery required to control IOP, was achieved in 67.4% of eyes. Among 40 eyes for which trabeculotomy with the TRAB360 was the first glaucoma surgery, the success rate was 70%. Among 18 primary congenital glaucoma (PCG) eyes for which trabeculotomy with the TRAB360 was the first glaucoma surgery, the success rate was 83.3%. Cyclodialysis-related hypotony was reported in two eyes (4.3%). Both of these eyes had angle anomalies that likely predisposed them to forming cyclodialysis clefts when traction was exerted on the trabecular meshwork. One eye resolved without further intervention and the other eye required surgical intervention to treat the hypotony. No other significant complications were reported.
“This study, the first to critically evaluate outcomes of circumferential ab interno trabeculotomy using the TRAB360 device to treat childhood glaucoma, shows that the procedure is a compelling early surgical intervention in pediatric glaucoma,” Alana Grajewski, MD, Professor of Clinical Ophthalmology and Director of The Samuel & Ethel Balkan International Pediatric Glaucoma Center at the Bascom Palmer Eye Institute, and co-author of the study, said in a company news release. “For years, my pediatric glaucoma specialist colleagues around the country and I have been using the Sight Sciences devices in pediatric cases because the technology uniquely provides access to all 360 degrees of the diseased conventional outflow pathway through a single clear corneal incision. Moving beyond TRAB360 with OMNI, we are adding viscodilation of the distal outflow system to the trabeculotomy, thereby providing our patients two sequential, comprehensive, canal-based MIGS procedures that together can target all 360 degrees of disease at all three levels of outflow resistance.”
OMNI targets all three levels of outflow resistance: a trabeculotomy procedure to address trabecular meshwork, and a viscodilation procedure to address Schlemm’s canal and the collector channels.
“As an early adopter of Sight Sciences’ first two single-purpose devices—TRAB360 for trabeculotomy and VISCO360 for canal viscodilation—I am pleased to have provided positive reinforcement and encouragement to the Sight Sciences team early on as they pushed forward to develop the fully integrated, dual-procedure OMNI Surgical System so that glaucoma surgeons around the world could better care for their patients with a comprehensive, multi-modal canal-based solution,” Dr. Grajewski said.
“Reviewing the positive clinical outcomes of the OMNI predecessor procedure in childhood glaucoma and thinking about our company’s role in helping equip pediatric surgeons with the tools they need to fight pediatric blindness has been truly inspirational for our team here at Sight Sciences, and is arguably one of the most satisfying and rewarding developments in my career personally,” said Sight Sciences co-founder and CEO Paul Badawi. “We have really enjoyed our close relationships with the pediatric glaucoma community and have learned so much from them over the years. As canal physiology experts, pediatric ophthalmic surgeons such as Dr. Grajewski, Dr. James Brandt (UC Davis), and many other surgeons beyond this published study have been major sources of inspiration to us over the years as we listen to customer needs and strive to provide them with the best shots on goal within the conventional outflow pathway.”