Back to resultsReproducibility of Nerve Fiber Layer Thickness Measurements in Patients With Glaucoma and Healthy Controls Using Spectral-Domain and Time-Domain OCT
Primary Purpose
Glaucoma Patients and Healthy Controls
Status
Terminated
Phase
Phase 4
Locations
Switzerland
Study Type
Interventional
Intervention
Spectralis® SD-OCT, Heidelberg Engineering GmbH, H
Sponsored by
About this trial
This is an interventional diagnostic trial for Glaucoma Patients and Healthy Controls
Eligibility Criteria
Inclusion criteria: control group:
age 18yo or older, healthy
glaucom group: age 18yo or older, diagnosis of primary open angle glaucoma (POAG)
Exclusion criteria: Exclusion criteria in the control group were history of glaucoma, history of any other ocular disease, or intraocular pressure greater than 21mmHg. Exclusion criteria in the glaucoma group were history of other optic neuropathies.
or severe optic media opacities.
Sites / Locations
Outcomes
Primary Outcome Measures
reproducibility of retinal nerve fiber layer thickness measurement
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01273285
Brief Title
Reproducibility of Nerve Fiber Layer Thickness Measurements in Patients With Glaucoma and Healthy Controls Using Spectral-Domain and Time-Domain OCT
Study Type
Interventional
2. Study Status
Record Verification Date
January 2011
Overall Recruitment Status
Terminated
Study Start Date
April 2009 (undefined)
Primary Completion Date
March 2010 (Actual)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
University of Zurich
4. Oversight
5. Study Description
Brief Summary
To assess the reproducibility of Spectral-Domain-OCT (SD-OCT) retinal nerve fiber layer thickness (RNFL) thickness measurements in healthy volunteers and patients with glaucoma and to compare these results to conventional Time-Domain-OCT (TD-OCT).
Trial with medical device
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Glaucoma Patients and Healthy Controls
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
50 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Device
Intervention Name(s)
Spectralis® SD-OCT, Heidelberg Engineering GmbH, H
Primary Outcome Measure Information:
Title
reproducibility of retinal nerve fiber layer thickness measurement
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion criteria: control group:
age 18yo or older, healthy
glaucom group: age 18yo or older, diagnosis of primary open angle glaucoma (POAG)
Exclusion criteria: Exclusion criteria in the control group were history of glaucoma, history of any other ocular disease, or intraocular pressure greater than 21mmHg. Exclusion criteria in the glaucoma group were history of other optic neuropathies.
or severe optic media opacities.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
01 Studienregister MasterAdmins
Organizational Affiliation
UniversitaetsSpital Zuerich
Official's Role
Study Director
Facility Information:
City
Zurich
Country
Switzerland
12. IPD Sharing Statement
Citations:
PubMed Identifier
21909812
Citation
Toteberg-Harms M, Sturm V, Knecht PB, Funk J, Menke MN. Repeatability of nerve fiber layer thickness measurements in patients with glaucoma and without glaucoma using spectral-domain and time-domain OCT. Graefes Arch Clin Exp Ophthalmol. 2012 Feb;250(2):279-87. doi: 10.1007/s00417-011-1811-9. Epub 2011 Sep 10.
Results Reference
derived
Learn more about this trial
Reproducibility of Nerve Fiber Layer Thickness Measurements in Patients With Glaucoma and Healthy Controls Using Spectral-Domain and Time-Domain OCT
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