Safety & Effectiveness Study of the Hydrus Microstent for Lowering IOP in Glaucoma Patients Undergoing Cataract Surgery (HORIZON)
Public ClinicalTrials.gov record NCT01539239. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
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
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT01539239
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Not applicable
- Enrollment
- 1,143 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 45 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Jan 2012 (Type not available)
- Primary completion
- Jun 2017 (Actual)
- Completion
- Jun 2020 (Actual)
- Last update posted
- Mar 12, 2021
2012 – 2020
United States locations
- U.S. sites
- 26
- U.S. states
- 17
- U.S. cities
- 26
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Not listed | Phoenix | Arizona | — | — |
| Not listed | Tucson | Arizona | — | — |
| Not listed | Fayetteville | Arkansas | — | — |
| Not listed | La Jolla | California | — | — |
| Not listed | Orange | California | — | — |
| Not listed | Sacramento | California | — | — |
| Not listed | Fort Collins | Colorado | — | — |
| Not listed | Parker | Colorado | — | — |
| Not listed | Bradenton | Florida | — | — |
| Not listed | Fort Myers | Florida | — | — |
| Not listed | Ocala | Florida | — | — |
| Not listed | Sioux City | Iowa | — | — |
| Not listed | Garden City | Kansas | — | — |
| Not listed | Louisville | Kentucky | — | — |
| Not listed | Sandwich | Massachusetts | — | — |
| Not listed | Bloomington | Minnesota | — | — |
| Not listed | Chesterfield | Missouri | — | — |
| Not listed | Wilmington | North Carolina | — | — |
| Not listed | Cleveland | Ohio | — | — |
| Not listed | Mason | Ohio | — | — |
| Not listed | Maryville | Tennessee | — | — |
| Not listed | Austin | Texas | — | — |
| Not listed | Dallas | Texas | — | — |
| Not listed | Fort Worth | Texas | — | — |
| Not listed | Salt Lake City | Utah | — | — |
| Not listed | Racine | Wisconsin | — | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 12 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT01539239, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Mar 12, 2021 · Synced Oct 21, 2026
Related: full search, browse by condition, browse by drug or therapy, browse by sponsor, browse by U.S. city.
Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT01539239 live on ClinicalTrials.gov.