Glaukos® iStent Infinite Trabecular Micro-Bypass System in Subjects With Mild to Moderate Primary Open-angle Glaucoma
Sponsor
Glaukos Corporation (Industry)
Overall Status
Recruiting
CT.gov ID
NCT06057051
Collaborator
(none)
245
1
1
47
5.2
Study Details
Study Description
Brief Summary
Prospective, multicenter, single-arm study of the iStent infinite in adult pseudophakic or phakic subjects with mild to moderate primary open angle glaucoma who have not failed conventional medical and surgical treatment
Condition or Disease | Intervention/Treatment | Phase |
---|---|---|
|
N/A |
Study Design
Study Type:
Interventional
Anticipated Enrollment
:
245 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Prospective, Multicenter Study of the Glaukos® iStent Infinite Trabecular Micro-Bypass System Model iS3 in Subjects With Mild to Moderate Primary Open-angle Glaucoma
Actual Study Start Date
:
Sep 1, 2023
Anticipated Primary Completion Date
:
Aug 1, 2025
Anticipated Study Completion Date
:
Aug 1, 2027
Arms and Interventions
Arm | Intervention/Treatment |
---|---|
Experimental: iStent Infinite iStent Infinite Trabecular Micro-Bypass System |
Device: iStent Infinite
iStent Infinite Trabecular Micro-Bypass System
|
Outcome Measures
Primary Outcome Measures
- Mean Diurnal Intraocular Pressure (IOP) 12-Month reduction ≥ 20% from Baseline [12 Months]
Eligibility Criteria
Criteria
Ages Eligible for Study:
35 Years
and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
-
Diagnosis of primary open-angle glaucoma
-
Phakic or pseudophakic
-
Age 35 years or older
Exclusion Criteria:
-
Traumatic, uveitic, neovascular, angle-closure glaucoma or
-
glaucoma associated with vascular disorders
-
Active corneal inflammation or edema
-
Retinal disorders not associated with glaucoma
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
---|---|---|---|---|---|
1 | Glaukos Investigator Site | Cincinnati | Ohio | United States | 45242 |
Sponsors and Collaborators
- Glaukos Corporation
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
Glaukos Corporation
ClinicalTrials.gov Identifier:
NCT06057051
Other Study ID Numbers:
- GLK-401-01
First Posted:
Sep 28, 2023
Last Update Posted:
Sep 28, 2023
Last Verified:
Sep 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
Additional relevant MeSH terms: