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