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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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ClinicalTrials.gov Identifier: NCT01273285
Recruitment Status : Terminated
First Posted : January 10, 2011
Last Update Posted : January 10, 2011
Sponsor:
Information provided by:
University of Zurich

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

Condition or disease Intervention/treatment Phase
Glaucoma Patients and Healthy Controls Device: Spectralis® SD-OCT, Heidelberg Engineering GmbH, H Phase 4

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 50 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Study Start Date : April 2009
Actual Primary Completion Date : March 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Glaucoma
U.S. FDA Resources




Primary Outcome Measures :
  1. reproducibility of retinal nerve fiber layer thickness measurement


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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01273285


Locations
Switzerland
Zurich, Switzerland
Sponsors and Collaborators
University of Zurich
Investigators
Study Director: 01 Studienregister MasterAdmins UniversitaetsSpital Zuerich

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Funk Jens, Prof. Dr. Dr., University hospital Zurich, AUG Augenklinik
ClinicalTrials.gov Identifier: NCT01273285     History of Changes
Other Study ID Numbers: RNFL-Repro
First Posted: January 10, 2011    Key Record Dates
Last Update Posted: January 10, 2011
Last Verified: January 2011

Additional relevant MeSH terms:
Glaucoma
Ocular Hypertension
Eye Diseases