Dec. 1, 2021
The Food and Drug Administration (FDA) has granted an Investigational Device Exemption (IDE) authorizing Sight Sciences to conduct a clinical study to assess the safety and effectiveness of a new, higher volume (21 microliters of viscoelastic fluid dispensed), investigational OMNI device to perform canal viscodilation alone to lower intraocular pressure (IOP) in adults with primary open-angle glaucoma (POAG), according to reporting by Vision Monday.
The Precision clinical trial is designed as a three-armed randomized controlled trial (RCT), which Sight Sciences believes will be the first of its kind and represents the largest MIGS (minimally invasive glaucoma surgery) clinical trial ever initiated, based on total number of patients receiving MIGS interventions in conjunction with cataract surgery. The devices that will be evaluated in the study are the higher volume OMNI from Sight Sciences) and the iStent Inject Canal Implant from Glaukos.
The OMNI Surgical System is a handheld, single use therapeutic device for MIGS. It is indicated for canaloplasty (the microcatheterization and viscodilation of Schlemm’s canal) followed by trabeculotomy (the cutting of trabecular meshwork) to reduce intraocular pressure in adult patients with POAG.
Other Articles to Explore
“I’m excited to begin this prospective study evaluating the safety and efficacy of standalone ab interno canaloplasty using the higher volume OMNI,” said Mark Gallardo, MD, El Paso Eye Surgeons, principal investigator of the Precision clinical trial. He said the procedure can become “a valuable first-line MIGS procedure for adults with mild to moderate POAG.”
