Purpose of This Study is to Evaluate the Safety and Efficacy of One, Two, or Three iStents for the Reduction of Intraocular Pressure in Open-angle Glaucoma Subjects

Primary Open Angle Glaucoma (POAG) Clinical Trial

Official title:

A Prospective, Randomized, Controlled Evaluation of Open-Angle Glaucoma Subjects on Two Topical Hypotensive Medications, Implanted With One, Two, or Three Trabecular Micro-Bypass Stents

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01252849
• Other study ID #: GCF-016
• Status: Completed
• Phase: N/A
• Start date: December 2010
• Est. completion date: October 8, 2019

Study information

• Verified date: August 2022
• Source: Glaukos Corporation
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to evaluate the safety and efficacy of the iStent medical device that is implanted into the eye and designed to reduce eye pressure in patients with your condition.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 119
• Est. completion date: October 8, 2019
• Est. primary completion date: October 8, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Diagnosed with primary open-angle glaucoma (POAG)

• Subject on two topical hypotensive medications

Exclusion Criteria:

• Traumatic, uveitic, neovascular, or angle closure glaucoma

• Fellow eye already enrolled

Related Conditions & MeSH terms

• Glaucoma
• Glaucoma, Open-Angle
• Primary Open Angle Glaucoma (POAG)

Intervention

Device:
• iStent
Implantation of One iStent through a small temporal clear corneal incision.
• iStent
Implantation of Two iStents through a small temporal clear corneal incision
• iStent
Implantation of Three iStents through a small temperal clear corneal incision

Locations

Country	Name	City	State
Armenia	S.V. Malayan's Ophthalmology Centre	Yerevan

Sponsors (1)

Lead Sponsor	Collaborator
Glaukos Corporation

Country where clinical trial is conducted

Armenia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mean diurnal IOP reduction of greater than or equal to 20% at month 12 vs. baseline		12 Months
Secondary	Mean diurnal IOP <18 mmHg at month 12		12 months