Phase 3
Completed N=239
A Study of the Trabecular Micro-bypass Stent in Combination With Cataract Surgery in Subjects With Open Angle Glaucoma
Source: ClinicalTrials.gov NCT00323284 ↗Enrolled (actual)
239
Serious AEs
0.8%
Results posted
Oct 2012
Primary outcomePrimary: Intraocular Pressure (Measured in mm Hg) Less or Equal to 21 mm Hg on no Topical Hypotensive Meds — 68; 50 percent of subjects achieving endpoint
Summary
The purpose of this study is to evaluate the safety and efficacy of the iStent trabecular micro-bypass stent in reducing intraocular pressure (IOP) in subjects with open-angle glaucoma or ocular hypertension and co-existing cataract.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Intraocular Pressure (Measured in mm Hg) Less or Equal to 21 mm Hg on no Topical Hypotensive Meds |
68; 50 | — |
| SECONDARY Efficacy |
64; 47 | — |
Eligibility Criteria
Inclusion Criteria
- Diagnosed with open-angle glaucoma (OAG) in the study eye. Pseudoexfoliative and pigmentary glaucoma are also acceptable diagnoses.
- Subject on at least one glaucoma medication
- Able and willing to attend follow up visits for two years post operative
- Able and willing to sign informed consent
Exclusion Criteria
- Prior glaucoma procedures (eg trabeculectomy, viscocanalostomy, ALT, SLT, shunt implant, collagen implant, cyclo destructive procedures etc)
- Angle closure glaucoma
- Fellow eye already enrolled
Data sourced from ClinicalTrials.gov (NCT00323284). 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.