Santa Rosa De Copan

This clinical trial is designed to evaluate the safety and effectiveness of a canaloplasty device in adults with open-angle glaucoma who are also undergoing cataract surgery. The trial focuses on subjects diagnosed with open-angle glaucoma characterized by specific eye pressure levels. It aims to gather data on how this new surgical system performs in a real-world setting. Participants in the study will receive treatment using the DF12 Canaloplasty and Trabeculotomy Surgical System during their cataract surgery. This device is intended to help manage eye pressure associated with glaucoma. The trial is prospective and multicenter, involving several locations to assess the device's safety and effectiveness in a first-in-human setting. Throughout the study, researchers will monitor changes in eye pressure over a 12-month period after treatment. Participants will be evaluated for safety and the impact of the device on glaucoma management. The total duration and follow-up include assessments to ensure ongoing monitoring of the treatment outcomes and any potential side effects.