NCT01444105
Completed
Not Applicable
A Prospective, Randomized, Controlled, Parallel Groups Evaluation of Open-angle Glaucoma Subjects on One Ocular Hypotensive Medication Randomized to Treatment With Two Trabecular Micro-bypass Stents or Selective Laser Trabeculoplasty
ConditionsOpen-angle Glaucoma
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Open-angle Glaucoma
- Sponsor
- Glaukos Corporation
- Enrollment
- 80
- Locations
- 1
- Primary Endpoint
- Change from baseline in mean diurnal IOP (mm Hg) at the Month 12 visit.
- Status
- Completed
- Last Updated
- 3 years ago
Overview
Brief Summary
Evaluation of intraocular pressure (IOP) lowering effect of two iStent stents versus a SLT procedure in subjects with open-angle glaucoma on one ocular hypotensive medication.
Detailed Description
Evaluation of intraocular pressure (IOP) lowering effect of two iStent stents versus a SLT procedure in subjects with open-angle glaucoma on one ocular hypotensive medication.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Phakic study eye or study eye with a posterior chamber intraocular lens (PC-IOL)
- •Primary open-angle glaucoma (including pseudoexfoliative)
Exclusion Criteria
- •Aphakic or pseudophakic with anterior chamber IOLs (AC-IOLs) (study eye)
- •Prior stent implantations (study eye)
Outcomes
Primary Outcomes
Change from baseline in mean diurnal IOP (mm Hg) at the Month 12 visit.
Time Frame: 12 Months
Study Sites (1)
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