search
Back to results

A Study of the Trabecular Micro-bypass Stent in Combination With Cataract Surgery in Subjects With Open Angle Glaucoma

Primary Purpose

Open-Angle Glaucoma

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
iStent plus Cataract Surgery
Cataract surgery only
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, Cataract, Surgery

Eligibility Criteria

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

Inclusion Criteria: Diagnosed with open-angle glaucoma (OAG) in the study eye. Pseudoexfoliative and pigmentary glaucoma are also acceptable diagnoses. Subject on at least one glaucoma medication Able and willing to attend follow up visits for two years post operative Able and willing to sign informed consent Exclusion Criteria: Prior glaucoma procedures (eg trabeculectomy, viscocanalostomy, ALT, SLT, shunt implant, collagen implant, cyclo destructive procedures etc) Angle closure glaucoma Fellow eye already enrolled

Sites / Locations

  • Assil Eye Institute
  • North Bay Eye Associates Inc
  • Ellison Ambulatory Care Center
  • Harvard Eye Associates
  • Shepard Eye Center
  • Glaucoma Consultants of Colorado
  • Florida Eye Microsurgical Institute, Inc.
  • The Center for Excellence in Eye Care
  • International Eye Center
  • Clayton Eye Center
  • Indiana University
  • Stiles Eyecare Excellence
  • The Eye Care Institute Building
  • Williamson Nelson Eye Center
  • Kresge Eye Institute
  • Great Lakes Eye Care
  • Chu Vision Institute
  • University of Minnesota
  • Mayo Clinic
  • Discover Vision Centers
  • Silverstein Eye Centers
  • The Shepherd Eye Center
  • Glaucoma Consultants of Capital Region
  • Donald J. Digby and Associates
  • James Branch MD
  • Cinicinnati Eye Institute
  • Laurel Eye Center
  • Wills Eye Hospital
  • Associates in Ophthalmology
  • UPMC Eye Center
  • Southeast Texas Medical Association, L.L.P.

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

A--iStent plus Cataract Surgery

B--Cataract Surgery Only

Arm Description

iStent plus Cataract Surgery

Cataract Surgery only

Outcomes

Primary Outcome Measures

Intraocular Pressure (Measured in mm Hg) Less or Equal to 21 mm Hg on no Topical Hypotensive Meds
Subjects with an intraocular pressure (IOP) less than or equal to 21 mm Hg without use of topical hypotensive medication at 12 months

Secondary Outcome Measures

Efficacy
Subjects with an intraocular pressure (IOP) reduction from baseline of greater than or equal to 20% without use of topical hypotensive medication at 12 months

Full Information

First Posted
May 6, 2006
Last Updated
December 14, 2017
Sponsor
Glaukos Corporation
search

1. Study Identification

Unique Protocol Identification Number
NCT00323284
Brief Title
A Study of the Trabecular Micro-bypass Stent in Combination With Cataract Surgery in Subjects With Open Angle Glaucoma
Official Title
A Study of the Glaukos Trabecular Micro-Bypass Stent in Combination With Cataract Surgery in Open Angle Glaucoma Subjects.
Study Type
Interventional

2. Study Status

Record Verification Date
March 2016
Overall Recruitment Status
Completed
Study Start Date
June 2005 (undefined)
Primary Completion Date
July 2009 (Actual)
Study Completion Date
March 2010 (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
The purpose of this study is to evaluate the safety and efficacy of the iStent trabecular micro-bypass stent in reducing intraocular pressure (IOP) in subjects with open-angle glaucoma or ocular hypertension and co-existing cataract.
Detailed Description
The purpose of this study is to evaluate the safety and efficacy of the iStent trabecular micro-bypass stent in reducing intraocular pressure (IOP) in subjects with open-angle glaucoma or ocular hypertension and co-existing cataract. Pre-operative unmedicated baseline pressures will be compared with post operative values in both study arms.

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, Cataract, Surgery

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Masking Description
IOP measurement
Allocation
Randomized
Enrollment
240 (Actual)

8. Arms, Groups, and Interventions

Arm Title
A--iStent plus Cataract Surgery
Arm Type
Active Comparator
Arm Description
iStent plus Cataract Surgery
Arm Title
B--Cataract Surgery Only
Arm Type
Active Comparator
Arm Description
Cataract Surgery only
Intervention Type
Device
Intervention Name(s)
iStent plus Cataract Surgery
Other Intervention Name(s)
iStent Surgery
Intervention Description
ab interno trabecular bypass stent surgery
Intervention Type
Procedure
Intervention Name(s)
Cataract surgery only
Other Intervention Name(s)
Phacoemulsification
Intervention Description
Cataract surgery only
Primary Outcome Measure Information:
Title
Intraocular Pressure (Measured in mm Hg) Less or Equal to 21 mm Hg on no Topical Hypotensive Meds
Description
Subjects with an intraocular pressure (IOP) less than or equal to 21 mm Hg without use of topical hypotensive medication at 12 months
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Efficacy
Description
Subjects with an intraocular pressure (IOP) reduction from baseline of greater than or equal to 20% without use of topical hypotensive medication at 12 months
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Diagnosed with open-angle glaucoma (OAG) in the study eye. Pseudoexfoliative and pigmentary glaucoma are also acceptable diagnoses. Subject on at least one glaucoma medication Able and willing to attend follow up visits for two years post operative Able and willing to sign informed consent Exclusion Criteria: Prior glaucoma procedures (eg trabeculectomy, viscocanalostomy, ALT, SLT, shunt implant, collagen implant, cyclo destructive procedures etc) Angle closure glaucoma Fellow eye already enrolled
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jeff Wells, PharmD, MBA
Organizational Affiliation
Glaukos Corporation
Official's Role
Study Director
Facility Information:
Facility Name
Assil Eye Institute
City
Beverly Hills
State/Province
California
ZIP/Postal Code
90210
Country
United States
Facility Name
North Bay Eye Associates Inc
City
Petaluma
State/Province
California
ZIP/Postal Code
94954
Country
United States
Facility Name
Ellison Ambulatory Care Center
City
Sacramento
State/Province
California
ZIP/Postal Code
95817
Country
United States
Facility Name
Harvard Eye Associates
City
San Clemente
State/Province
California
ZIP/Postal Code
92673
Country
United States
Facility Name
Shepard Eye Center
City
Santa Maria
State/Province
California
ZIP/Postal Code
93454
Country
United States
Facility Name
Glaucoma Consultants of Colorado
City
Littleton
State/Province
Colorado
ZIP/Postal Code
80120
Country
United States
Facility Name
Florida Eye Microsurgical Institute, Inc.
City
Boynton Beach
State/Province
Florida
ZIP/Postal Code
33426
Country
United States
Facility Name
The Center for Excellence in Eye Care
City
Miami
State/Province
Florida
ZIP/Postal Code
33176
Country
United States
Facility Name
International Eye Center
City
Tampa
State/Province
Florida
ZIP/Postal Code
33603
Country
United States
Facility Name
Clayton Eye Center
City
Morrow
State/Province
Georgia
ZIP/Postal Code
30260
Country
United States
Facility Name
Indiana University
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46260
Country
United States
Facility Name
Stiles Eyecare Excellence
City
Overland Park
State/Province
Kansas
ZIP/Postal Code
66213
Country
United States
Facility Name
The Eye Care Institute Building
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40206
Country
United States
Facility Name
Williamson Nelson Eye Center
City
Baton Rouge
State/Province
Louisiana
ZIP/Postal Code
70806
Country
United States
Facility Name
Kresge Eye Institute
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48201
Country
United States
Facility Name
Great Lakes Eye Care
City
Saint Joseph
State/Province
Michigan
ZIP/Postal Code
49085
Country
United States
Facility Name
Chu Vision Institute
City
Edina
State/Province
Minnesota
ZIP/Postal Code
55435
Country
United States
Facility Name
University of Minnesota
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55404
Country
United States
Facility Name
Mayo Clinic
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
Facility Name
Discover Vision Centers
City
Independence
State/Province
Missouri
ZIP/Postal Code
64055
Country
United States
Facility Name
Silverstein Eye Centers
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64133
Country
United States
Facility Name
The Shepherd Eye Center
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89121
Country
United States
Facility Name
Glaucoma Consultants of Capital Region
City
Slingerlands
State/Province
New York
ZIP/Postal Code
12159
Country
United States
Facility Name
Donald J. Digby and Associates
City
Greensboro
State/Province
North Carolina
ZIP/Postal Code
27408
Country
United States
Facility Name
James Branch MD
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27101
Country
United States
Facility Name
Cinicinnati Eye Institute
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45242
Country
United States
Facility Name
Laurel Eye Center
City
Brookville
State/Province
Pennsylvania
ZIP/Postal Code
15825
Country
United States
Facility Name
Wills Eye Hospital
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19107
Country
United States
Facility Name
Associates in Ophthalmology
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15122
Country
United States
Facility Name
UPMC Eye Center
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15213
Country
United States
Facility Name
Southeast Texas Medical Association, L.L.P.
City
Beaumont
State/Province
Texas
ZIP/Postal Code
77702
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
20828829
Citation
Samuelson TW, Katz LJ, Wells JM, Duh YJ, Giamporcaro JE; US iStent Study Group. Randomized evaluation of the trabecular micro-bypass stent with phacoemulsification in patients with glaucoma and cataract. Ophthalmology. 2011 Mar;118(3):459-67. doi: 10.1016/j.ophtha.2010.07.007. Epub 2010 Sep 15.
Results Reference
result
PubMed Identifier
22814041
Citation
Craven ER, Katz LJ, Wells JM, Giamporcaro JE; iStent Study Group. Cataract surgery with trabecular micro-bypass stent implantation in patients with mild-to-moderate open-angle glaucoma and cataract: two-year follow-up. J Cataract Refract Surg. 2012 Aug;38(8):1339-45. doi: 10.1016/j.jcrs.2012.03.025.
Results Reference
result

Learn more about this trial

A Study of the Trabecular Micro-bypass Stent in Combination With Cataract Surgery in Subjects With Open Angle Glaucoma

We'll reach out to this number within 24 hrs