N/A
N=306
Comparing Hydrus Microstent(TM) to the iStent for Lowering IOP in Glaucoma Patients Undergoing Cataract Surgery
Primary Open Angle Glaucoma · Pseudoexfoliative Glaucoma · Pigmentary Dispersion Glaucoma
Bottom Line
View on ClinicalTrials.gov: NCT02024464 ↗Enrolled (actual)
306
Serious AEs
3.3%
Results posted
Jun 2024
Primary outcome: Primary: Unmedicated Mean Diurnal Intraocular Pressure (DIOP) at Month 12 — 16.9; 18.1 mmHg
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Hydrus Microstent (Device); iStent Trabecular Micro Bypass (Device); Cataract removal and intraocular lens (IOL) implantation (Procedure)
- Age
- Adult, Older Adult · 21+ yrs
- Sex
- All
- Sponsor
- Ivantis, Inc.
- Primary completion
- Mar 2017
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Unmedicated Mean Diurnal Intraocular Pressure (DIOP) at Month 12 |
16.9; 18.1 | — |
| SECONDARY Percentage of Subjects With 20% Reduction From Baseline in Unmedicated DIOP at Month 12 |
82.0; 83.7 | — |
| SECONDARY Percentage of Subjects With Unmedicated DIOP of Not Less Than 5 mmHg and Not More Than 18 mmHg at Month 12 |
68.3; 67.4 | — |
Summary
This clinical trial compares two implantable devices intended to lower the pressure inside the eye of glaucoma patients. One of the two devices will be implanted immediately following cataract surgery and the placement of a posterior chamber intra-ocular lens. Only one eye (study eye) will be implanted.
Eligibility Criteria
Inclusion Criteria
- A diagnosis of primary open angle glaucoma (POAG), Pseudoexfoliative (PXG) glaucoma, or Pigmentary dispersion glaucoma (PDG)
- An operable age-related cataract with BCVA of 20/40 or worse, eligible for phacoemulsification.
Exclusion Criteria
- Forms of primary or secondary glaucoma not listed above
- Prior glaucoma surgery in the study eye
Data sourced from ClinicalTrials.gov (NCT02024464). 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.