Actively Recruiting
Study of the DF12 Canaloplasty and Trabeculotomy Surgical System for Treating Open-Angle Glaucoma During Cataract Surgery
Led by New World Medical, Inc. · Updated on 2026-02-27
70
Participants Needed
3
Research Sites
4 weeks
Total Duration
AI-Summary
What this Trial Is About
Researchers are evaluating a canaloplasty device for people with open-angle glaucoma undergoing cataract surgery. The study aims to assess the safety and effectiveness of this device in managing eye pressure in this condition. This first-in-human trial is conducted by New World Medical, Inc. and is designed to provide important information about this surgical system. Participants will be treated with a US FDA-approved canaloplasty device during their cataract surgery. The study focuses on how the device affects intraocular pressure IOP and the need for IOP-lowering medications over time. There is one treatment group involving the use of this canaloplasty and trabeculotomy surgical system. During the study, participants will have their intraocular pressure measured, with the main outcome being the change in IOP one year after surgery. Researchers will also monitor IOP levels and medication use at 12 months. The study begins in September 2025 and continues through October 2027, involving regular follow-up visits to track safety and effectiveness results.
CONDITIONS
Brief Title
Clinical Trial to Evaluate the Safety and Effectiveness of a Canaloplasty Device in Subjects With Open-Angle Glaucoma
Research Team
S
Swetha Mandava, MS
E
Elysia Ison, OD,FAAO
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