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NCT01455467 Clinical Trial

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

Open-angle Glaucoma Clinical Trial

Official title:
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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01455467
Other study ID # GCF-024
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date September 2011
Est. completion date October 18, 2019

Study information
Verified date August 2022
Source Glaukos Corporation
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 79
Est. completion date October 18, 2019
Est. primary completion date October 18, 2019
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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)

Study Design

Related Conditions & MeSH terms

Intervention

Device:
• One iStent
Implantation of one iStent in conjunction with cataract surgery
• Two iStent
Implantation of two iStent in conjunction with cataract surgery

Locations
Country Name City State
Armenia S.V. Malayan Ophthalmological Center Yerevan

Sponsors (1)
Lead Sponsor Collaborator
Glaukos Corporation

Country where clinical trial is conducted

Armenia, 

Outcome
Type Measure Description Time frame Safety issue
Primary Mean diurnal IOP reduction of = 20% vs. baseline mean diurnal IOP 12 Months
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