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

POAG Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05696561
• Other study ID #: DF12-CL-22-01
• Status: Not yet recruiting
• Phase: N/A
• Start date: June 2024
• Est. completion date: December 2025

Study information

• Verified date: April 2024
• Source: New World Medical, Inc.
• Contact: Heather P Reynolds, MS
• Phone: 8176881689
• Email: hreynolds[@]newworldmedical.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 100
• Est. completion date: December 2025
• Est. primary completion date: July 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 22 Years and older

Eligibility

Inclusion Criteria:

1. Subjects qualifying for cataract surgery

2. Subjects with diagnosis of open-angle glaucoma in at least one eye with unmedicated IOP of 22-34 mmHg.

Exclusion Criteria:

1. Patients who cannot be washed-out of IOP-lowering medications.

Related Conditions & MeSH terms

• Glaucoma
• Glaucoma, Open-Angle
• POAG

Intervention

Device:
• Canaloplasty Device
Canaloplasty

Locations

Country	Name	City	State
Costa Rica	Clinica 20/20	San José
Honduras	Centro Oftalmologico Robles	Santa Rosa De Copán
Mexico	Laser y Ultrasonido Ocular	Puebla

Sponsors (1)

Lead Sponsor	Collaborator
New World Medical, Inc.

Countries where clinical trial is conducted

Costa Rica,  Honduras,  Mexico, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	IOP change	proportion of treated eyes with > 20% change in unmedicated IOP	Month6
Secondary	IOP	Change in IOP	Months 6 and 12
Secondary	IOP meds	Change in number of IOP lowering medications	Month 6 and 12