NCT05696561

Clinical Trial to Evaluate the Safety and Effectiveness of a Canaloplasty Device in Subjects With Open-Angle Glaucoma

A Prospective, Multicenter, First in Human Clinical Trial to Evaluate the Safety and Effectiveness of the DF12 CANALOPLASTY AND TRABECULOTOMY SURGICAL SYSTEM in Subjects With Open-Angle Glaucoma Undergoing Cataract Surgery

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 70 (estimated)
• Sponsor: New World Medical, Inc. · Industry
• Sex: All
• Age: 22 Years
• Healthy volunteers: Not accepted

Summary

Clinical Trial to Evaluate the Safety and Effectiveness of a Canaloplasty Device in Subjects with Open-Angle Glaucoma

Conditions

• OAG - Open-Angle Glaucoma

Interventions

Type	Name	Description
DEVICE	Canaloplasty Device	Canaloplasty

Timeline

• Start date: 2025-09-09
• Primary completion: 2027-09-01
• Completion: 2027-10-01
• First posted: 2023-01-25
• Last updated: 2026-02-27

Locations

3 sites across 3 countries: Chile, Costa Rica, Honduras

Regulatory

• FDA-regulated device study