FDA grants IDE for clinical trial of higher-volume Omni device
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The FDA has issued an investigational device exemption for a clinical study to evaluate the safety and effectiveness of a higher-volume Omni device for canal viscodilation in adults with primary open-angle glaucoma.
The three-armed randomized controlled PRECISION trial will evaluate the higher-volume Omni (Sight Sciences) and iStent inject (Glaukos), according to a press release from Sight Sciences.
“The higher volume (21 µL vs. 11 µL) of viscoelastic may provide for a greater expansion of Schlemm’s canal and the distal collector system, which in turn may allow for enhanced aqueous outflow with a resultant reduction in pressure,” Mark Gallardo, MD, principal investigator of the PRECISION trial, said in the release. “This procedure can become a valuable first-line MIGS procedure for adults with mild to moderate POAG.”
Four hundred fifty-nine patients will be included in the trial. Patients will be administered cataract surgery in conjunction with ab interno canaloplasty alone with higher-volume Omni, sequential canaloplasty and trabeculotomy using higher-volume Omni, or implantation of two iStent injects.
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