N/A
Completed N=152
Comparing Effectiveness of the Hydrus Microstent (TM) to Two iStents to Lower IOP in Phakic Eyes
Open-angle glaucoma · Pseudoexfoliative Glaucoma · Pigmentary Glaucoma
Source: ClinicalTrials.gov NCT02023242 ↗
Enrolled (actual)
152
Serious AEs
13.8%
Results posted
Dec 2019
Primary outcomePrimary: Unmedicated IOP </= 19 mmHg at 12 Months — 34.2; 13.3 percentage of participants
Summary
This clinical trial compares two implantable devices intended to lower the pressure inside the eye of glaucoma patients.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Unmedicated IOP </= 19 mmHg at 12 Months |
34.2; 13.3 | — |
| SECONDARY The Percentage of Subjects Who Are Not Using Ocular Hypotensive Medications at 12 and 24 Months |
46.6; 24.0; 38.0; 18.7 | — |
| SECONDARY Mean Medication Use at 12 and 24 Months |
0.99; 1.69; 1.23; 1.91 | — |
| SECONDARY Unmedicated IOP </= 19 mmHg at 24 Months |
23.9; 13.3 | — |
| SECONDARY Unmedicated IOP </= 18 mmHg at 12 Months |
30.1; 9.3 | — |
Eligibility Criteria
Inclusion Criteria
- A diagnosis of primary open angle glaucoma (POAG), Pseudoexfoliative (PXG) glaucoma, or Pigmentary glaucoma (PG)
- A phakic lens with BCVA of 20/30 or better
Exclusion Criteria
- Forms of primary or secondary glaucoma not listed above
- Prior glaucoma surgery in the study eye
Data sourced from ClinicalTrials.gov (NCT02023242). 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.