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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: Completed NA study, sponsored by Ivantis.
NCT01539239 is a NA study that has completed, run by Ivantis. The registered enrollment target is 1,143 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (19% lower). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
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.
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 |
What the finished NCT01539239 record still lists
NCT01539239 is an interventional study that assigns participants to a tested intervention. Its 1,143 participants enrollment target places it among the larger protocols in the corpus, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (19% lower).
The record links to 0 conditions, and to 2 interventions - of which Cataract surgery is the first listed.
NCT01539239 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01539239's enrollment target sits among peer trials
1,143 92nd of 2000 higher than 1,909 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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