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
Verified date | September 2022 |
Source | Glaukos Corporation |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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 |
Country | Name | City | State |
---|---|---|---|
Armenia | S.V. Malayan Ophthalmology Centre | Yerevan |
Lead Sponsor | Collaborator |
---|---|
Glaukos Corporation |
Armenia,
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 |