A Prospective Evaluation of Open-Angle Glaucoma Subjects on Two Topical Hypotensive Medications Treated With One Suprachoroidal Stent

Subject With Primary Open-angle Glaucoma (POAG) Clinical Trial

Official title:

A Prospective Evaluation of Open-angle Glaucoma Subjects on Two Topical Hypotensive Medication Treated With One Suprachoroidal Stent

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01252914
• Other study ID #: GCF-019
• Status: Completed
• Phase: Phase 4
• Start date: December 2010
• Est. completion date: December 16, 2019

Study information

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

Clinical Trial Summary

The purpose of this study is to assess the efficacy and safety of one iStent supra stent in the reduction of intraocular pressure associated with primary open-angle glaucoma.

Description:

The study assesses the efficacy and safety of one iStent supra stent in the reduction of intraocular pressure associated with primary open-angle glaucoma.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: December 16, 2019
• Est. primary completion date: December 16, 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)

• Subjects 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
• Subject With Primary Open-angle Glaucoma (POAG)

Intervention

Device:
• iStent Supra Stent
Implantation of one iStent Supra Stent through a small temporal clear corneal incision

Locations

Country	Name	City	State
Armenia	S.V. Malayan 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
Other	Safety	Rate of ocular adverse events through 61 months; Findings from Intraocular Pressure, best corrected visual acuity, visual field, specular microscopy measurements; Findings from slit-lamp, fundus and gonioscopic examinations	0-61 months
Primary	Mean diurnal Intraocular Pressure reduction of greater than or equal to 20% at month 12 vs. baseline		12 months
Secondary	Mean diurnal Intraocular Pressure < 18 mmHg at month 12		12 months