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NCT01444105 Clinical Trial

Open-angle Glaucoma Subjects on One Ocular Hypotensive Medication Randomized to Treatment With Two Trabecular Micro-bypass Stents or Selective Laser Trabeculoplasty

Open-angle Glaucoma Clinical Trial

Official title:
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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01444105
Other study ID # GCF-028
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date September 2011
Est. completion date April 9, 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 two iStent stents versus a SLT procedure in subjects with open-angle glaucoma on one ocular hypotensive medication.

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.

Recruitment information / eligibility
Status Completed
Enrollment 80
Est. completion date April 9, 2019
Est. primary completion date April 9, 2019
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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)

Study Design

Related Conditions & MeSH terms

Intervention

Device:
• iStent
Implantation of two iStent devices
Other:
• SLT
Laser treatment

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 Change from baseline in mean diurnal IOP (mm Hg) at the Month 12 visit. 12 Months
See also
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