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NCT01539239 · ClinicalTrials.gov registry record · NA
Safety & Effectiveness Study of the Hydrus Microstent for Lowering IOP in Glaucoma Patients Undergoing Cataract Surgery (HORIZON)
A NA study, sponsored by Ivantis.
- Completed
- Registry status
- NA
- Development phase
- 1,143
- Enrollment target
NCT01539239 is a NA study that has completed, run by Ivantis. The registered enrollment target is 1,143 participants.
The verdict
NCT01539239, a NA study, has completed, sponsored by Ivantis.
- COMPLETED
- Registry status
- NA
- Development phase
- 1,143 participants
- Enrollment target
Study Summary
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.
Interventions
- PROCEDURE Cataract surgery
- DEVICE Hydrus Aqueous Implant
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,143 participants |
| Start Date | 2012-01 |
| Est. Completion | 2020-06 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01539239
The ClinicalTrials.gov registry entry for NCT01539239 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 1,143 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Ivantis, which has 3 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Cataract surgery is the first listed.
NCT01539239 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01539239 about?
NCT01539239 is a clinical study titled "Safety & Effectiveness Study of the Hydrus Microstent for Lowering IOP in Glaucoma Patients Undergoing Cataract Surgery (HORIZON)". 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 ...
What is the current status of trial NCT01539239?
This trial is currently completed. It is a NA study. The enrollment target is 1,143 participants. The study started on 2012-01. Estimated completion is 2020-06.
What interventions are being tested in trial NCT01539239?
The interventions under investigation include: Cataract surgery (PROCEDURE), Hydrus Aqueous Implant (DEVICE).
Who is sponsoring clinical trial NCT01539239?
This trial is sponsored by Ivantis, which has 3 total clinical trials registered on ClinicalTrials.gov.
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