Text Size

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:
Information provided by:
University of Zurich
ClinicalTrials.gov Identifier:
NCT01273285
First received: January 7, 2011
Last updated: NA
Last verified: January 2011
History: No changes posted
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic

Resource links provided by NLM:

U.S. FDA Resources

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01273285

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

No publications provided by University of Zurich

Additional 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
Study First Received: January 7, 2011
Last Updated: January 7, 2011
Health Authority: Switzerland: Swissmedic

Additional relevant MeSH terms:
Glaucoma
Ocular Hypertension
Eye Diseases

ClinicalTrials.gov processed this record on May 19, 2013