The multicentre, retrospective interventional clinical study involved 46 eyes in 41 patients, with a median age of 12 months and a median follow-up period of 14.5 months
US-based medical device company Sight Sciences, has unveiled positive results from a new multicentre study of TRAB360 device, a predecessor of OMNI Surgical System.
The multicentre, retrospective interventional clinical study, involving 46 eyes in 41 patients, is titled ‘Trabeculotomy Ab Interno with the TRAB360 Device for Childhood Glaucomas’, and its results were published in the American Journal of Ophthalmology.
The company said that its current clinical study follows a 2019 trial, which evaluated circumferential ab interno trabeculotomy (goniotomy) using TRAB360 in standalone MIGS surgery.
Sight Sciences co-founder and CEO Paul Badawi 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.
“As canal physiology experts, pediatric ophthalmic surgeons such as Dr. Alana Grajewski, Dr. James Brandt, 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.”
TRAB360 Trabeculotomy System is a manual surgical ophthalmic instrument
The study has demonstrated positive results for TRAB360, with 67.4% surgical success, and 70% success rate in 40 eyes, for which trabeculotomy using TRAB360 is the first glaucoma surgery, along with 83.3% success rate in 18 primary congenital glaucoma (PCG) eyes.
The OMNI Surgical System is a manually operated device, designed to deliver small amounts of viscoelastic fluid during ophthalmic surgery, and also indicated to cut trabecular meshwork tissue during trabeculotomy procedures.
The system is said to combine the functionalities of its two predecessor devices, TRAB360 for trabeculotomy and VISCO360 for transluminal viscoelastic delivery, into one device, to target the sources of resistance in the conventional outflow pathway, including trabecular meshwork, Schlemm’s canal, and collector channels with a single device and single surgery.
Sight Sciences said that its TRAB360 Trabeculotomy System is a manual surgical ophthalmic instrument designed to mechanically cut the trabecular meshwork.
Co-author of the study Alana Grajewski said: “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.
“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.”