Clinical Trial to Evaluate the Safety and Effectiveness of a Canaloplasty Device in Subjects With Open-Angle Glaucoma
Sponsor
New World Medical, Inc. (Industry)
Overall Status
Not yet recruiting
CT.gov ID
NCT05696561
Collaborator
(none)
40
1
15
Study Details
Study Description
Brief Summary
Clinical Trial to Evaluate the Safety and Effectiveness of a Canaloplasty Device in Subjects with Open-Angle Glaucoma
Condition or Disease | Intervention/Treatment | Phase |
---|---|---|
|
N/A |
Study Design
Study Type:
Interventional
Anticipated Enrollment
:
40 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Clinical Trial to Evaluate the Safety and Effectiveness of a Canaloplasty Device in Subjects With Open-Angle Glaucoma
Anticipated Study Start Date
:
Aug 1, 2023
Anticipated Primary Completion Date
:
Jun 1, 2024
Anticipated Study Completion Date
:
Nov 1, 2024
Arms and Interventions
Arm | Intervention/Treatment |
---|---|
Experimental: Treatment with a Canaloplasty Device Canaloplasty Device |
Device: Canaloplasty Device
Canaloplasty
|
Outcome Measures
Primary Outcome Measures
- IOP decrease [Month6]
proportion of treated eyes with > 20% decrease in unmedicated IOP
Secondary Outcome Measures
- IOP [Months 6 and 12]
Reduction in IOP
- IOP meds [Month 6 and 12]
Change in number of IOP lowering medications
Eligibility Criteria
Criteria
Ages Eligible for Study:
22 Years
and Older
Sexes Eligible for Study:
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:
- Patients who cannot be washed-out of IOP-lowering medications.
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- New World Medical, Inc.
Investigators
- Study Director: Mark Sun, PhD, New World Medical, Inc.
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
New World Medical, Inc.
ClinicalTrials.gov Identifier:
NCT05696561
Other Study ID Numbers:
- DF12-CL-22-01
First Posted:
Jan 25, 2023
Last Update Posted:
Jan 25, 2023
Last Verified:
Jan 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
Yes
Product Manufactured in and Exported from the U.S.:
Yes
Additional relevant MeSH terms: