- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03478293
iStent Inject in OAG Subjects on 2 Pre-op Topical Ocular Hypotensive Medications
September 6, 2022 updated by: Glaukos Corporation
A Prospective Evaluation of the Second Generation iStent Inject in Open-Angle Glaucoma Subjects on Two Preoperative Topical Ocular Hypotensive Medications
The purpose of this study is to evaluate the intraocular pressure (IOP) lowering effect of iStent inject in eyes of subjects with primary open-angle glaucoma previously on two anti-glaucoma medications.
Study Overview
Status
Terminated
Conditions
Intervention / Treatment
Detailed Description
The purpose of this study is to evaluate the intraocular pressure (IOP) lowering effect of iStent inject in eyes of subjects with primary open-angle glaucoma previously on two anti-glaucoma medications.
Outcomes will be evaluated at 12 and 24 months.
Study Type
Interventional
Enrollment (Actual)
6
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
São Paulo, Brazil, 04023-62
- Department of Ophthalmology - UNIFESP/ Hospital São Paulo
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Diagnosed with primary open angle glaucoma (POAG)
- Subject on two ocular hypotensive medications
Exclusion Criteria:
- Traumatic, uveitic, neovascular, or angle closure glaucoma
- Fellow eye already enrolled
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: iStent inject surgery
Single-arm study.
Intervention is micro-invasive glaucoma surgery (MIGS) to implant iStent inject
|
Micro-invasive glaucoma surgery (MIGS) to implant iStent inject
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
IOP reduction at 12 and 24 months on same number or fewer medications
Time Frame: 12 months and 24 months
|
IOP reduction at 12 and 24 months on same number or fewer medications
|
12 months and 24 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Kerry Stephens, OD, Glaukos Corporation
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
February 27, 2018
Primary Completion (Actual)
December 30, 2020
Study Completion (Actual)
December 30, 2020
Study Registration Dates
First Submitted
March 20, 2018
First Submitted That Met QC Criteria
March 20, 2018
First Posted (Actual)
March 27, 2018
Study Record Updates
Last Update Posted (Actual)
September 9, 2022
Last Update Submitted That Met QC Criteria
September 6, 2022
Last Verified
September 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- GCF-045
Drug and device information, study documents
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
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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