A Prospective Evaluation of Glaucoma Subjects Treated With Two Second Generation iStents and One iStent Supra

Not Applicable

Terminated

• Conditions: Glaucoma, Open-Angle
• Interventions: Device: G2 and G3

• Registration Number: NCT03255798
• Lead Sponsor: Glaukos Corporation

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

Study Timeline

• Study Start: 2017-08-01
• Study First Submitted: 2017-08-17
• Study First Submitted QC: 2017-08-17
• Study First Posted: 2017-08-21
• Primary Completion: 2019-06-06
• Study Completion: 2019-06-06
• Status Verified: 2022-09
• Last Update Submitted: 2022-09-06
• Last Update Posted: 2022-09-09

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 7

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
G2 and G3 implantation	G2 and G3	Two iStent inject stents and one iStent Supra stent

Primary Outcome Measures

Name	Time	Method
20% IOP reduction	Month 12	IOP reduction observed compared to baseline IOP, measured by Goldmann tonometry in mm Hg

Secondary Outcome Measures

Name	Time	Method
IOP less than or equal to 18 mm Hg	Month 12	IOP compared to baseline IOP, measured by Goldmann tonometry in mm Hg

Trial Locations

Locations (1)

Prof. Dr. med. Carl Erb; 🇩🇪 Berlin, Germany