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
Location: See all (3) locations...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY
Clinical Trial to Evaluate the Safety and Effectiveness of a Canaloplasty Device in Subjects with Open-Angle Glaucoma
Eligibility
Participation Requirements
Sex: All
Minimum Age: 22
Healthy Volunteers: f
View:
• Subjects qualifying for cataract surgery
• Subjects with diagnosis of open-angle glaucoma in at least one eye with unmedicated IOP of 22-34 mmHg.
Locations
Other Locations
Chile
Centro de la Vision
RECRUITING
Santiago
Costa Rica
Clínica 20/20
RECRUITING
San José
Honduras
Centro Oftalmologico Robles
NOT_YET_RECRUITING
Santa Rosa De Copán
Contact Information
Primary
Swetha Mandava, MS
smandava@newworldmedical.com
9732049467
Backup
Elysia Ison, OD,FAAO
eison@newworldmedical.com
4083487408
Time Frame
Start Date: 2025-09-09
Estimated Completion Date: 2027-10
Participants
Target number of participants: 70
Treatments
Other: Treatment with a Canaloplasty Device
US. FDA Approved Canaloplasty Device
Related Therapeutic Areas
Sponsors
Leads: New World Medical, Inc.