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NCT03255798 Clinical Trial

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

Glaucoma, Open-Angle Clinical Trial

— GCF-041  

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

Clinical Trial Details — Status: Terminated

Administrative data
NCT number NCT03255798
Other study ID # GCF-041
Secondary ID
Status Terminated
Phase N/A
First received
Last updated
Start date August 1, 2017
Est. completion date June 6, 2019

Study information
Verified date September 2022
Source Glaukos Corporation
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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

Description:

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

Recruitment information / eligibility
Status Terminated
Enrollment 7
Est. completion date June 6, 2019
Est. primary completion date June 6, 2019
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Device:
• G2 and G3
Two iStent inject devices and one iStent supra device

Locations
Country Name City State
Germany Prof. Dr. med. Carl Erb Berlin

Sponsors (1)
Lead Sponsor Collaborator
Glaukos Corporation

Country where clinical trial is conducted

Germany, 

Outcome
Type Measure Description Time frame Safety issue
Primary 20% IOP reduction IOP reduction observed compared to baseline IOP, measured by Goldmann tonometry in mm Hg Month 12
Secondary IOP less than or equal to 18 mm Hg IOP compared to baseline IOP, measured by Goldmann tonometry in mm Hg Month 12
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