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

Primary Purpose

Open-angle Glaucoma

Status
Completed
Phase
Not Applicable
Locations
Armenia
Study Type
Interventional
Intervention
iStent
SLT
Sponsored by
Glaukos Corporation
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Open-angle Glaucoma focused on measuring Open angle glaucoma, Pseudoexfoliative glaucoma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • S.V. Malayan Ophthalmological Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

iStent

SLT

Arm Description

implantation of two iStent devices

Laser treatment

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
September 28, 2011
Last Updated
August 29, 2022
Sponsor
Glaukos Corporation
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1. Study Identification

Unique Protocol Identification Number
NCT01444105
Brief Title
Open-angle Glaucoma Subjects on One Ocular Hypotensive Medication Randomized to Treatment With Two Trabecular Micro-bypass Stents or Selective Laser Trabeculoplasty
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
Study Type
Interventional

2. Study Status

Record Verification Date
August 2022
Overall Recruitment Status
Completed
Study Start Date
September 2011 (Actual)
Primary Completion Date
April 9, 2019 (Actual)
Study Completion Date
April 9, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Glaukos Corporation

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Open-angle Glaucoma
Keywords
Open angle glaucoma, Pseudoexfoliative glaucoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
80 (Actual)

8. Arms, Groups, and Interventions

Arm Title
iStent
Arm Type
Active Comparator
Arm Description
implantation of two iStent devices
Arm Title
SLT
Arm Type
Active Comparator
Arm Description
Laser treatment
Intervention Type
Device
Intervention Name(s)
iStent
Intervention Description
Implantation of two iStent devices
Intervention Type
Other
Intervention Name(s)
SLT
Intervention Description
Laser treatment
Primary Outcome Measure Information:
Title
Change from baseline in mean diurnal IOP (mm Hg) at the Month 12 visit.
Time Frame
12 Months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lilit A Voskanyan, MD, PhD
Organizational Affiliation
S.V. Malayan Ophthalmological Center, Yerevan, Armenia
Official's Role
Principal Investigator
Facility Information:
Facility Name
S.V. Malayan Ophthalmological Center
City
Yerevan
ZIP/Postal Code
0001
Country
Armenia

12. IPD Sharing Statement

Citations:
PubMed Identifier
35943114
Citation
Rolim-de-Moura CR, Paranhos A Jr, Loutfi M, Burton D, Wormald R, Evans JR. Laser trabeculoplasty for open-angle glaucoma and ocular hypertension. Cochrane Database Syst Rev. 2022 Aug 9;8(8):CD003919. doi: 10.1002/14651858.CD003919.pub3.
Results Reference
derived

Learn more about this trial

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

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