N/A
Completed N=108
Post-approval Study of The Glaukos® iStent® Trabecular Micro-bypass Stent: Extended Follow-up of the Premarket Cohort
Source: ClinicalTrials.gov NCT01836042 ↗Enrolled (actual)
108
Serious AEs
0.0%
Results posted
Apr 2016
Primary outcomePrimary: Rate of Sight-threatening Adverse Events — 27.8; 45.7; 34.3 percentage of subjects
Summary
The purpose of this study is to assess the long-term safety of the Glaukos® iStent® Trabecular Micro-Bypass Stent Model GTS100R/L in subjects previously enrolled in Glaukos Study GC-003.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Rate of Sight-threatening Adverse Events |
27.8; 45.7; 34.3 | — |
Eligibility Criteria
Inclusion Criteria
- Subjects previously enrolled in Glaukos Study GC-003 who are able and willing to participate in this extended follow-up study
Exclusion Criteria
- Subjects previously enrolled in Glaukos Study GC-003 who are not able or willing to participate in this extended follow-up study
- Patients not previously enrolled in Glaukos Study GC-003
Data sourced from ClinicalTrials.gov (NCT01836042). 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.