N/A
Completed N=556
Safety & Effectiveness Study of the Hydrus Microstent for Lowering IOP in Glaucoma Patients Undergoing Cataract Surgery (HORIZON)
Source: ClinicalTrials.gov NCT01539239 ↗Enrolled (actual)
556
Serious AEs
2.9%
Results posted
Sep 2019
Primary outcomePrimary: Reduction in Mean Diurnal IOP From Baseline at 24 Months Following Medication Washout. — 77.2; 57.8 percentage of eyes
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Reduction in Mean Diurnal IOP From Baseline at 24 Months Following Medication Washout. |
77.2; 57.8 | — |
| SECONDARY Mean Diurnal Washed Out IOP Change From Baseline at 24 Months Compared Between Treatment and Control Groups. |
-7.5; -5.3 | — |
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT01539239). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.