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Clinical Trials/NCT03255798
NCT03255798
Terminated
Not Applicable

A Prospective Evaluation of Mild to Moderate Open-Angle Glaucoma Subjects Treated With Two Second Generation Micro-bypass Stents and One Suprachoroidal Stent

Glaukos Corporation1 site in 1 country7 target enrollmentAugust 1, 2017

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Glaucoma, Open-Angle
Sponsor
Glaukos Corporation
Enrollment
7
Locations
1
Primary Endpoint
20% IOP reduction
Status
Terminated
Last Updated
3 years ago

Overview

Brief Summary

Prospective Evaluation of Open-Angle Glaucoma Subjects treated with two second generation iStents and one iStent Supra

Detailed Description

Prospective Evaluation of Mild to Moderate Open-Angle Glaucoma Subjects treated with Two Second Generation Microbypass Stents and One Suprachoroidal Stent

Registry
clinicaltrials.gov
Start Date
August 1, 2017
End Date
June 6, 2019
Last Updated
3 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Phakic or pseudophakic subjects with posterior chamber IOLs Primary open-angle glaucoma or pseudoexfoliative glaucoma diagnosis Subject on two ocular hypotensive medications Medicated screening IOP greater than or equal to 18 mm Hg and less than or equal to 30 mm Hg Visual field or optic nerve defect characteristic of glaucoma Normal iridocorneal angle anatomy Absence of peripheral anterior synechiae Mean diurnal IOP at baseline between 21 and 45 mm Hg

Exclusion Criteria

  • Subjects with anterior chamber IOLs Prior SLT or stent implantation in study eye Traumatic, uveitic, or neovascular glaucoma Fellow eye BCVA worse than 20/200

Outcomes

Primary Outcomes

20% IOP reduction

Time Frame: Month 12

IOP reduction observed compared to baseline IOP, measured by Goldmann tonometry in mm Hg

Secondary Outcomes

  • IOP less than or equal to 18 mm Hg(Month 12)

Study Sites (1)

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