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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

This study has been terminated.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01273285
First Posted: January 10, 2011
Last Update Posted: January 10, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
University of Zurich
  Purpose

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

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic

Resource links provided by NLM:


Further study details as provided by University of Zurich:

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

Enrollment: 50
Study Start Date: April 2009
Primary Completion Date: March 2010 (Final data collection date for primary outcome measure)
  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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.

  Contacts and Locations
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
  More Information

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 Submitted: January 7, 2011
First Posted: January 10, 2011
Last Update Posted: January 10, 2011
Last Verified: January 2011

Additional relevant MeSH terms:
Glaucoma
Ocular Hypertension
Eye Diseases