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Multicenter Post-Approval Study Of The Glaukos® iStent® Trabecular Micro-Bypass Stent System In Conjunction With Cataract Surgery

Primary Purpose

Primary Open Angle Glaucoma

Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
iStent
Cataract surgery
Sponsored by
Glaukos Corporation
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Primary Open Angle Glaucoma focused on measuring Primary open-angle glaucoma (POAG), Trabecular meshwork, iStent

Eligibility Criteria

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

Inclusion Criteria:

  • mild to moderate primary open-angle glaucoma
  • currently treated with ocular hypotensive medication
  • pseudoexfoliative and pigmentary glaucoma are acceptable diagnoses
  • subject scheduled to undergo cataract surgery

Exclusion Criteria:

  • primary angle-closure glaucoma; or secondary angle closure glaucoma, including neovascular glaucoma
  • retrobulbar tumor, thyroid eye disease, Sturge-Weber syndrome or any other type of condition that may cause elevated episcleral venous pressure

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

iStent

Cataract surgery

Arm Description

Implantation of one iStent in conjunction with cataract surgery

Cataract surgery alone

Outcomes

Primary Outcome Measures

Rate of sight-threatening adverse events

Secondary Outcome Measures

Other adverse events
For other adverse events such as increase in intra-ocular pressure (IOP) of ≥ 10 mmHg at any time postoperative, loss of best spectacle corrected visual acuity of ≥ 2 lines (≥ 10 letters) postoperative as compared to baseline or best recorded visual acuity measured at any visit postoperative, the rate of each event at each visit will be calculated for the two treatment groups separately.

Full Information

First Posted
April 24, 2013
Last Updated
October 18, 2021
Sponsor
Glaukos Corporation
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1. Study Identification

Unique Protocol Identification Number
NCT01841450
Brief Title
Multicenter Post-Approval Study Of The Glaukos® iStent® Trabecular Micro-Bypass Stent System In Conjunction With Cataract Surgery
Official Title
A Prospective, Controlled, Multicenter Post-Approval Study Of The Glaukos® iStent® Trabecular Micro-Bypass Stent System In Conjunction With Cataract Surgery
Study Type
Interventional

2. Study Status

Record Verification Date
October 2021
Overall Recruitment Status
Unknown status
Study Start Date
July 2013 (Actual)
Primary Completion Date
August 2021 (Actual)
Study Completion Date
November 2021 (Anticipated)

3. Sponsor/Collaborators

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

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The purpose of this study is to assess the long-term safety of the Glaukos® iStent® Trabecular Micro-Bypass Stent Model GTS100 in conjunction with cataract surgery vs. cataract surgery only, in subjects with mild to moderate open-angle glaucoma.
Detailed Description
The purpose of this study is to assess the long-term safety of the Glaukos® iStent® Trabecular Micro-Bypass Stent Model GTS100 in conjunction with cataract surgery compared to cataract surgery only, in subjects with mild to moderate open-angle glaucoma.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Primary Open Angle Glaucoma
Keywords
Primary open-angle glaucoma (POAG), Trabecular meshwork, iStent

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
360 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
iStent
Arm Type
Experimental
Arm Description
Implantation of one iStent in conjunction with cataract surgery
Arm Title
Cataract surgery
Arm Type
Active Comparator
Arm Description
Cataract surgery alone
Intervention Type
Device
Intervention Name(s)
iStent
Other Intervention Name(s)
GTS100
Intervention Description
Implantation of one iStent in conjunction with cataract surgery
Intervention Type
Procedure
Intervention Name(s)
Cataract surgery
Intervention Description
Cataract surgery alone
Primary Outcome Measure Information:
Title
Rate of sight-threatening adverse events
Time Frame
36 months
Secondary Outcome Measure Information:
Title
Other adverse events
Description
For other adverse events such as increase in intra-ocular pressure (IOP) of ≥ 10 mmHg at any time postoperative, loss of best spectacle corrected visual acuity of ≥ 2 lines (≥ 10 letters) postoperative as compared to baseline or best recorded visual acuity measured at any visit postoperative, the rate of each event at each visit will be calculated for the two treatment groups separately.
Time Frame
36 months
Other Pre-specified Outcome Measures:
Title
Diurnal IOP reduction ≥ 20%
Time Frame
Baseline and 24 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
22 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: mild to moderate primary open-angle glaucoma currently treated with ocular hypotensive medication pseudoexfoliative and pigmentary glaucoma are acceptable diagnoses subject scheduled to undergo cataract surgery Exclusion Criteria: primary angle-closure glaucoma; or secondary angle closure glaucoma, including neovascular glaucoma retrobulbar tumor, thyroid eye disease, Sturge-Weber syndrome or any other type of condition that may cause elevated episcleral venous pressure
Facility Information:
City
Irvine
State/Province
California
ZIP/Postal Code
92604
Country
United States
City
Montebello
State/Province
California
ZIP/Postal Code
90640
Country
United States
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30342
Country
United States
City
Edgewood
State/Province
Kentucky
ZIP/Postal Code
41017
Country
United States
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40217
Country
United States
City
Jackson
State/Province
Michigan
ZIP/Postal Code
49202
Country
United States
City
Saint Joseph
State/Province
Michigan
ZIP/Postal Code
49085
Country
United States
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64151
Country
United States
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63131
Country
United States
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27101
Country
United States
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45242
Country
United States
City
Mentor
State/Province
Ohio
ZIP/Postal Code
44060
Country
United States
City
Kingston
State/Province
Pennsylvania
ZIP/Postal Code
18704
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Multicenter Post-Approval Study Of The Glaukos® iStent® Trabecular Micro-Bypass Stent System In Conjunction With Cataract Surgery

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