N/A
N=100
Hydrus Microstent for Refractory Open-Angle Glaucoma
Open-angle Glaucoma
Bottom Line
View on ClinicalTrials.gov: NCT03267134 ↗Enrolled (actual)
100
Serious AEs
2.5%
Results posted
Jan 2026
Primary outcome: Primary: Percentage of Subjects With Greater Than or Equal to a 20 Percent Decrease From Baseline in Mean Diurnal Intraocular Pressure (MDIOP) at Month 12 While Maintaining the Same or Fewer Number of Medications as at Baseline — 43.0 percentage of subjects
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Hydrus Microstent (Device); Ophthalmic surgery (Procedure)
- Age
- Adult, Older Adult · 45+ yrs
- Sex
- All
- Sponsor
- Ivantis, Inc.
- Primary completion
- Dec 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Subjects With Greater Than or Equal to a 20 Percent Decrease From Baseline in Mean Diurnal Intraocular Pressure (MDIOP) at Month 12 While Maintaining the Same or Fewer Number of Medications as at Baseline |
43.0 | — |
| SECONDARY Mean Change From Baseline in MDIOP at Month 12 |
-3.77 | — |
Summary
The purpose of this study is to assess the safety and effectiveness of the Hydrus Microstent in patients with refractory open-angle glaucoma.
Eligibility Criteria
Inclusion Criteria
- Open-angle glaucoma with optic nerve pathology;
- BCVA of 20/80 or better in study eye;
- Refractory glaucoma;
- Other protocol-specified inclusion criteria may apply.
Exclusion Criteria
- Secondary glaucoma other than pseudoexfoliative and pigmentary glaucoma;
- Acute angle closure, chronic angle closure, or congenial, malignant, or developmental glaucoma;
- Pre-perimetric glaucoma;
- Ocular hypertension
- Shallow or flat anterior chamber;
- Other protocol-specified exclusion criteria may apply.
Data sourced from ClinicalTrials.gov (NCT03267134). 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.