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A Study of the iStent in Combo With Cataract Surgery in Newly Diagnosed Open Angle Glaucoma or OH Patients.

Primary Purpose

Open-Angle Glaucoma

Status
Completed
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Glaucoma 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, Surgery, Cataract

Eligibility Criteria

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

Inclusion Criteria: Newly diagnosed with open-angle glaucoma (OAG) or Ocular Hypertension with subjects not yet taking any glaucoma medications or recently diagnosed with mild open-angle glaucoma and are currently being treated with up to 2 glaucoma medications. All subjects must need cataract surgery. Exclusion Criteria: Angle closure glaucoma Secondary glaucomas except pseudoexfoliative and pigmentary; no neovascular, uveitic or angle recession glaucoma Prior glaucoma procedures (eg trabeculectomy, viscocanalostomy, ALT, SLT, shunt implant, collagen implant, cyclo destructive procedures etc) Fellow eye already enrolled

Sites / Locations

  • Vienna Medical Hospital
  • Mainz University
  • Augenklinik der Technischen Universitat
  • Universitats- Augenklinik
  • The Netherlands Ophthalmic Research Institute
  • Ophthalmic Clinic
  • Clinico San Carlos
  • Instituto Oftalmológico de Aragón
  • Beyoglu Eye Research and Education Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

1

2

Arm Description

Outcomes

Primary Outcome Measures

Efficacy

Secondary Outcome Measures

Full Information

First Posted
May 12, 2006
Last Updated
March 7, 2018
Sponsor
Glaukos Corporation
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1. Study Identification

Unique Protocol Identification Number
NCT00326066
Brief Title
A Study of the iStent in Combo With Cataract Surgery in Newly Diagnosed Open Angle Glaucoma or OH Patients.
Official Title
A Study of the Trabecular Micro-bypass Stent in Combination With Cataract Surgery in Subjects With Newly Diagnosed Open Angle Glaucoma and Subjects Diagnosed With Ocular Hypertension
Study Type
Interventional

2. Study Status

Record Verification Date
March 2018
Overall Recruitment Status
Completed
Study Start Date
February 2005 (undefined)
Primary Completion Date
May 2013 (Actual)
Study Completion Date
May 2013 (Actual)

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 evaluate the safety and efficacy of the iStent trabecular micro-bypass stent in reducing intraocular pressure (IOP) in subjects with newly diagnosed open-angle glaucoma and subjects diagnosed with Ocular hypertension.
Detailed Description
The study will compare the reduction in IOP of those subjects implanted with two Glaukos micro-stents with the reduction in IOP for patients receiving only primary medical therapy (Xalatan - Latanoprost) or cataract surgery alone. Both groups will undergo routine cataract surgery.

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, Surgery, Cataract

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Active Comparator
Arm Title
2
Arm Type
Placebo Comparator
Intervention Type
Device
Intervention Name(s)
Glaucoma Surgery
Other Intervention Name(s)
two Glaukos iStent Trabecular Bypass Microstents
Intervention Description
Comparing the effect in reducing IOP with two Trabecular Bypass Microstents Versus none in patients undergoing cataract surgery, with early open angle glaucoma or ocular hypertension.
Intervention Type
Procedure
Intervention Name(s)
cataract surgery only
Other Intervention Name(s)
Phacoemulsification
Intervention Description
Subjects will undergo routine cataract surgery only (no stent implant).
Primary Outcome Measure Information:
Title
Efficacy
Time Frame
24 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Newly diagnosed with open-angle glaucoma (OAG) or Ocular Hypertension with subjects not yet taking any glaucoma medications or recently diagnosed with mild open-angle glaucoma and are currently being treated with up to 2 glaucoma medications. All subjects must need cataract surgery. Exclusion Criteria: Angle closure glaucoma Secondary glaucomas except pseudoexfoliative and pigmentary; no neovascular, uveitic or angle recession glaucoma Prior glaucoma procedures (eg trabeculectomy, viscocanalostomy, ALT, SLT, shunt implant, collagen implant, cyclo destructive procedures etc) Fellow eye already enrolled
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Head of Clinical Affairs
Organizational Affiliation
Glaukos Corporation
Official's Role
Study Director
Facility Information:
Facility Name
Vienna Medical Hospital
City
Vienna
ZIP/Postal Code
A-1090
Country
Austria
Facility Name
Mainz University
City
Mainz
Country
Germany
Facility Name
Augenklinik der Technischen Universitat
City
Munich
ZIP/Postal Code
81675
Country
Germany
Facility Name
Universitats- Augenklinik
City
Wurzburg
ZIP/Postal Code
D-97080
Country
Germany
Facility Name
The Netherlands Ophthalmic Research Institute
City
Amsterdam
Country
Netherlands
Facility Name
Ophthalmic Clinic
City
Rotterdam
Country
Netherlands
Facility Name
Clinico San Carlos
City
Madrid
ZIP/Postal Code
28040
Country
Spain
Facility Name
Instituto Oftalmológico de Aragón
City
Zaragoza
ZIP/Postal Code
50007
Country
Spain
Facility Name
Beyoglu Eye Research and Education Hospital
City
Istanbul
Country
Turkey

12. IPD Sharing Statement

Citations:
PubMed Identifier
20207977
Citation
Fernandez-Barrientos Y, Garcia-Feijoo J, Martinez-de-la-Casa JM, Pablo LE, Fernandez-Perez C, Garcia Sanchez J. Fluorophotometric study of the effect of the glaukos trabecular microbypass stent on aqueous humor dynamics. Invest Ophthalmol Vis Sci. 2010 Jul;51(7):3327-32. doi: 10.1167/iovs.09-3972. Epub 2010 Mar 5.
Results Reference
derived

Learn more about this trial

A Study of the iStent in Combo With Cataract Surgery in Newly Diagnosed Open Angle Glaucoma or OH Patients.

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