NCT05696561RecruitingNot Applicable
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
New World Medical, Inc.3 sites in 3 countries70 target enrollmentStarted: September 9, 2025Last updated:
Conditions
Interventions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- New World Medical, Inc.
- Enrollment
- 70
- Locations
- 3
- Primary Endpoint
- IOP change
Study Overview
Brief Summary
Clinical Trial to Evaluate the Safety and Effectiveness of a Canaloplasty Device in Subjects with Open-Angle Glaucoma
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 22 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Subjects qualifying for cataract surgery
- •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.
Arms & Interventions
Treatment with a Canaloplasty Device
Other
US. FDA Approved Canaloplasty Device
Intervention: Canaloplasty Device (Device)
Outcomes
Primary Outcomes
IOP change
Time Frame: Month12
Reduction in unmedicated IOP
Secondary Outcomes
- IOP(Month12)
- IOP meds(Month12)
Investigators
Study Sites (3)
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