CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 240 enrolled
Drug / intervention
iStent plus Cataract Surgery +1 moredevice
Likely dose
Not stated in record
Key inclusion· 3
  • ✓Diagnosed with open-angle glaucoma (OAG) in the study eye; pseudoexfoliative and pigmentary glaucoma also acceptable
  • ✓Currently on at least one glaucoma medication
  • ✓Willing and able to attend follow-up visits for 2 years post-operative
Key exclusion· 3
  • ✕Prior glaucoma procedures (trabeculectomy, viscocanalostomy, argon laser trabeculoplasty, selective laser trabeculoplasty, shunt implant, collagen implant, cyclo-destructive procedures, etc.)
  • ✕Angle-closure glaucoma
  • ✕Fellow eye already enrolled in the study

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00323284
NCT00323284Phase 3Completed
CompareCT.gov

A Study of the Glaukos Trabecular Micro-Bypass Stent in Combination With Cataract Surgery in Open Angle Glaucoma Subjects.

Glaukos Corporation·interventional·Posted May 9, 2006·Updated Jan 12, 2018

In Brief

A Phase 3 clinical trial evaluating iStent plus Cataract Surgery and Cataract surgery only for Open-Angle Glaucoma. Completed, enrolled 240 participants across 31 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsOpen-Angle Glaucoma
CountriesUnited States
Collaborators--

Timeline

Phase 3CompletedFinished
20052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedMay 9, 2006
Enrollment StartJun 1, 2005
Primary CompletionJul 1, 2009
Study CompletionMar 1, 2010
TodayJul 2, 2026
Enrollment to primary: 4.1 yearsPosted 20.1 years ago

Interventions

iStent plus Cataract Surgerydevice

ab interno trabecular bypass stent surgery

Cataract surgery onlyprocedure

Cataract surgery only