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Clinical Trials/NCT01455467
NCT01455467
Completed
Not Applicable

A Prospective Evaluation of Open-angle Glaucoma Subjects on One Topical Hypotensive Medication Randomized to Treatment With One or Two Trabecular Micro-bypass Stents in Conjunction With Cataract Surgery

Glaukos Corporation1 site in 1 country79 target enrollmentSeptember 2011
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ConditionsOpen-angle Glaucoma

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Open-angle Glaucoma
Sponsor
Glaukos Corporation
Enrollment
79
Locations
1
Primary Endpoint
Mean diurnal IOP reduction of ≥ 20% vs. baseline mean diurnal IOP
Status
Completed
Last Updated
3 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSitesSimilar Trials

Overview

Brief Summary

Evaluation of intraocular pressure (IOP) lowering effect of one iStent versus two iStents in conjunction with cataract surgery in subjects with primary open-angle glaucoma, washed out of one anti-glaucoma medication prior to stent implantation.

Registry
clinicaltrials.gov
Start Date
September 2011
End Date
October 18, 2019
Last Updated
3 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • •Phakic study eye requiring cataract removal and posterior chamber intraocular lens (PC-IOL) implantation
  • •Primary open-angle glaucoma (including pigmentary or pseudoexfoliative)

Exclusion Criteria

  • •Aphakic or pseudophakic with posterior or anterior chamber IOLs (PC-IOLs or AC-IOLs) (study eye)
  • •Prior stent implantations (study eye)

Outcomes

Primary Outcomes

Mean diurnal IOP reduction of ≥ 20% vs. baseline mean diurnal IOP

Time Frame: 12 Months

Study Sites (1)

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