Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
NA
358 participants
INTERVENTIONAL
2020-09-22
2026-05-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Implantation
Subjects will undergo cataract surgery and then implantation of the iStent Inject trabecular micro-bypass device.
iStent Inject Implantation
Subjects will be implanted with the iStent Injection Micro-Bypass device
Interventions
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iStent Inject Implantation
Subjects will be implanted with the iStent Injection Micro-Bypass device
Eligibility Criteria
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Inclusion Criteria
2. Mild to moderate primary open-angle glaucoma
3. Scheduled to undergo cataract surgery
4. Able and willing to attend scheduled follow-up exams for three years postoperatively
5. Able and willing to provide written informed consent on the IRB approved Informed Consent Form
Operative Inclusion Criterion:
6. Successful, uncomplicated cataract surgery
Exclusion Criteria
2. Traumatic, malignant, uveitic, or neovascular glaucoma or discernible congenital anomalies of the anterior chamber angle
3. Retrobulbar tumor, thyroid eye disease, Sturge-Weber Syndrome or any other type of condition that may cause elevated episcleral venous pressure
22 Years
ALL
No
Sponsors
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Glaukos Corporation
INDUSTRY
Responsible Party
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Locations
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Eye Doctors of Arizona, PLLC
Phoenix, Arizona, United States
Wolstan and Goldberg Eye Associates
Torrance, California, United States
Glaucoma Associates of Texas
Dallas, Texas, United States
Countries
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Other Identifiers
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IG2M-105-PASN
Identifier Type: -
Identifier Source: org_study_id
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