Glaukos® iStent Infinite Trabecular Micro-Bypass System in Subjects With Mild to Moderate Primary Open-angle Glaucoma
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
1 other identifier
interventional
245
1 country
1
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Sep 2023
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2023
CompletedFirst Submitted
Initial submission to the registry
September 21, 2023
CompletedFirst Posted
Study publicly available on registry
September 28, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2027
ExpectedSeptember 28, 2023
September 1, 2023
1.9 years
September 21, 2023
September 26, 2023
Conditions
Outcome Measures
Primary Outcomes (1)
Mean Diurnal Intraocular Pressure (IOP) 12-Month reduction ≥ 20% from Baseline
12 Months
Study Arms (1)
iStent Infinite
EXPERIMENTALiStent Infinite Trabecular Micro-Bypass System
Interventions
Eligibility Criteria
You may qualify if:
- Diagnosis of primary open-angle glaucoma
- Phakic or pseudophakic
- Age 35 years or older
You may not qualify if:
- Traumatic, uveitic, neovascular, angle-closure glaucoma or
- glaucoma associated with vascular disorders
- Active corneal inflammation or edema
- Retinal disorders not associated with glaucoma
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Glaukos Investigator Site
Cincinnati, Ohio, 45242, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 21, 2023
First Posted
September 28, 2023
Study Start
September 1, 2023
Primary Completion
August 1, 2025
Study Completion (Estimated)
August 1, 2027
Last Updated
September 28, 2023
Record last verified: 2023-09
Data Sharing
- IPD Sharing
- Will not share