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: