Primary Open Angle Glaucoma Clinical Trial
Official title:
The Safety and Effectiveness of the Hydrus Aqueous Implant for Lowering Intraocular Pressure in Glaucoma Patients Undergoing Cataract Surgery, A Prospective, Multicenter, Randomized, Controlled Clinical Trial
NCT number | NCT01539239 |
Other study ID # | CP-11-001 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | January 2012 |
Est. completion date | June 2020 |
Verified date | February 2021 |
Source | Ivantis, Inc. |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
This clinical trial is a prospective, randomized, controlled, multicenter, study. After informed consent is obtained, patients will be evaluated for eligibility based on glaucoma severity, eye health, and visual acuity. Following successful screening, use of all topical glaucoma medications will be stopped for a period of "washout" to establish a qualifying medication-free intraocular pressure (IOP) value. Clinical follow up will be scheduled over the course of the 24 month study, and examinations will be repeated to monitor eye health. At the 1 and 2 year follow up, those patients on ocular hypotensive medications will be instructed to washout, and then have the diurnal (IOP taken in the morning, mid-day, and afternoon in the same day) IOP evaluation. Annual follow up will occur up to 5 years. The primary effectiveness endpoint is a decrease in diurnal IOP from baseline compared to the 24 months diurnal IOP following medication washout.
Status | Completed |
Enrollment | 1143 |
Est. completion date | June 2020 |
Est. primary completion date | June 2017 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 45 Years and older |
Eligibility | Inclusion Criteria: - An operable age-related cataract - A diagnosis of POAG treated with 1 to 4 hypotensive medications - Medicated IOP = 31 mmHg - Diurnal IOP = 22 mmHg and = 34 mmHg Exclusion Criteria: - Congenital or developmental glaucoma - Previous argon laser trabeculoplasty - Ab-interno or ab-externo device implanted in or through Schlemm's Canal - Use of oral hypotensive medication for glaucoma for treatment of fellow eye |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Ivantis, Inc. |
United States, Canada, Germany, Italy, Mexico, Philippines, Poland, Spain, United Kingdom,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Reduction in Mean Diurnal IOP From Baseline at 24 Months Following Medication Washout. | Percentage of eyes in which diurnal IOP was reduced by greater than or equal to 20% at 24 months postoperative compared to baseline after washout of topical glaucoma medications. | Baseline and 24 months | |
Secondary | Mean Diurnal Washed Out IOP Change From Baseline at 24 Months Compared Between Treatment and Control Groups. | Mean diurnal IOP change from baseline at 24 months between both groups after washout of topical glaucoma medications. | Baseline and 24 months |
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