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A Prospective, Unmasked Evaluation of the iStent in Patients With Primary Open-Angle Glaucoma (SY)

Primary Purpose

Glaucoma, Eye Diseases, Glaucoma, Open-Angle

Status
Completed
Phase
Phase 4
Locations
International
Study Type
Interventional
Intervention
iStent
Sponsored by
Glaukos Corporation
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Glaucoma focused on measuring primary open angle glaucoma (POAG), OAG, glaucoma

Eligibility Criteria

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

Inclusion Criteria:

  • Diagnosis of primary open-angle glaucoma
  • Male or female at least 18 years of age and able to provide written informed consent
  • Mean IOP (at baseline visit after washout of any medications) must be at least 22 mm Hg and no greater than 38 mm Hg
  • Likely to be available and willing to attend follow-up visits

Exclusion Criteria:

  • Angle closure glaucoma
  • Secondary glaucomas
  • Prior glaucoma procedures
  • Elevated episcleral venous pressure from history of active thyroid orbitopathy, carotid-cavernous fistula, orbital tumors, or orbital congestive disease

Sites / Locations

  • S.V. Malayan's Ophtalmology Centre
  • Allgemeines Krankenhaus Wien
  • Chu de Lyon Hospital Edouard Herriot
  • CHNO des Quinze-Vingts
  • Hopital Saint-Joseph
  • Knapschaftskrankenhaus Bochum Langendreer
  • Universitatsklinkum Erlangen
  • Universitatsklinikum Magdeburg A.o.R.
  • Dietrich-Bonhoeffer-Klinikum Neubrandenburg
  • Universita' degli Studi di Parma
  • Universita'di Torino
  • Hospital clinico San Carlos
  • Hospital Torrevieja Salud, UTE

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

iStent

Arm Description

Outcomes

Primary Outcome Measures

IOP 18 mm Hg or less without medications
IOP 18 mm Hg or less with or without medications

Secondary Outcome Measures

Mean IOP

Full Information

First Posted
June 1, 2009
Last Updated
May 18, 2015
Sponsor
Glaukos Corporation
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1. Study Identification

Unique Protocol Identification Number
NCT00911924
Brief Title
A Prospective, Unmasked Evaluation of the iStent in Patients With Primary Open-Angle Glaucoma
Acronym
SY
Official Title
A Prospective, Unmasked Evaluation of the iStent in Patients With Primary Open-Angle Glaucoma
Study Type
Interventional

2. Study Status

Record Verification Date
May 2015
Overall Recruitment Status
Completed
Study Start Date
May 2009 (undefined)
Primary Completion Date
September 2013 (Actual)
Study Completion Date
September 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
Prospective, unmasked, evaluation of the iStent in patients that have primary open-angle glaucoma (OAG). Stent implantation in one eye will be used for analysis, with medication added at 6 months, as required.
Detailed Description
One hundred patients will be enrolled in the study at up to 21 sites; follow-up is through 1 year.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Glaucoma, Eye Diseases, Glaucoma, Open-Angle
Keywords
primary open angle glaucoma (POAG), OAG, glaucoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
112 (Actual)

8. Arms, Groups, and Interventions

Arm Title
iStent
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
iStent
Other Intervention Name(s)
stent, trabecular micro-bypass stent
Intervention Description
Glaukos iStent, medication
Primary Outcome Measure Information:
Title
IOP 18 mm Hg or less without medications
Time Frame
At 6 months
Title
IOP 18 mm Hg or less with or without medications
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Mean IOP
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Diagnosis of primary open-angle glaucoma Male or female at least 18 years of age and able to provide written informed consent Mean IOP (at baseline visit after washout of any medications) must be at least 22 mm Hg and no greater than 38 mm Hg Likely to be available and willing to attend follow-up visits Exclusion Criteria: Angle closure glaucoma Secondary glaucomas Prior glaucoma procedures Elevated episcleral venous pressure from history of active thyroid orbitopathy, carotid-cavernous fistula, orbital tumors, or orbital congestive disease
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
S.V. Malayan's Ophtalmology Centre
City
Yerevan
ZIP/Postal Code
375108
Country
Armenia
Facility Name
Allgemeines Krankenhaus Wien
City
Wien
ZIP/Postal Code
1090
Country
Austria
Facility Name
Chu de Lyon Hospital Edouard Herriot
City
Lyon
ZIP/Postal Code
69437
Country
France
Facility Name
CHNO des Quinze-Vingts
City
Paris
ZIP/Postal Code
75012
Country
France
Facility Name
Hopital Saint-Joseph
City
Paris
ZIP/Postal Code
75014
Country
France
Facility Name
Knapschaftskrankenhaus Bochum Langendreer
City
Bochum
ZIP/Postal Code
44892
Country
Germany
Facility Name
Universitatsklinkum Erlangen
City
Erlangen
Country
Germany
Facility Name
Universitatsklinikum Magdeburg A.o.R.
City
Magdeburg
ZIP/Postal Code
39120
Country
Germany
Facility Name
Dietrich-Bonhoeffer-Klinikum Neubrandenburg
City
Neubrandenburg
ZIP/Postal Code
17036
Country
Germany
Facility Name
Universita' degli Studi di Parma
City
Parma
ZIP/Postal Code
43100
Country
Italy
Facility Name
Universita'di Torino
City
Torino
ZIP/Postal Code
10128
Country
Italy
Facility Name
Hospital clinico San Carlos
City
Madrid
ZIP/Postal Code
28040
Country
Spain
Facility Name
Hospital Torrevieja Salud, UTE
City
Torrevieja
ZIP/Postal Code
03186
Country
Spain

12. IPD Sharing Statement

Citations:
PubMed Identifier
24452726
Citation
Voskanyan L, Garcia-Feijoo J, Belda JI, Fea A, Junemann A, Baudouin C; Synergy Study Group. Prospective, unmasked evaluation of the iStent(R) inject system for open-angle glaucoma: synergy trial. Adv Ther. 2014 Feb;31(2):189-201. doi: 10.1007/s12325-014-0095-y. Epub 2014 Jan 23.
Results Reference
result

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A Prospective, Unmasked Evaluation of the iStent in Patients With Primary Open-Angle Glaucoma

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