Reproducibility of Retinal Nerve Fiber Layer Thickness Measurements Using the Eye Tracker and Retest Function of Spectralis® SD-OCT in Glaucomatous Eyes and Healthy Controls

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. Identifier: NCT01228721
Recruitment Status : Terminated
First Posted : October 26, 2010
Last Update Posted : October 26, 2010
Information provided by:
University of Zurich

Brief Summary:

PURPOSE. To evaluate the impact of self-acting eyetracking and retest software on the reproducibility of retinal nerve fiber layer (RNFL) thickness measurements in glaucoma patients and healthy control subjects using Spectralis® SD-OCT.

METHODS. RNFL thickness was measured in 56 normal and 47 glaucomatous eyes by one operator within one session with a brief rest between measurements. Three measurements were taken with the eye-tracker and retest function, and three were taken without this function, alternating between measurement methods.

  • Trial with medical device

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

Study Type : Interventional  (Clinical Trial)
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Study Start Date : January 2009
Study Completion Date : December 2010

Resource links provided by the National Library of Medicine

U.S. FDA Resources

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

Information from the National Library of Medicine

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

Inclusion criteria:

  • Visual acuity of more or equal to 0.5 Snellen, refractive error less than ±5.00 diopters (D) spheric and ±3.00 D cylindrical and no history of ocular trauma or of any other severe ocular disease (particularly diseases affecting the optic nerve or surgery other than uncomplicated cataract surgery).
  • Additional inclusion criteria for the glaucoma group were a diagnosis of primary open angle glaucoma (POAG) or PEX-glaucoma.

Exclusion criteria:

  • Exclusion criteria for the control group were history of glaucoma or intraocular pressure beyond 21 mmHg and optic disc cupping of more than 0.6

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 identifier (NCT number): NCT01228721

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

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Funk Jens, Prof. Dr. Dr., University Hospital Zurich, AUG Augenklinik, Identifier: NCT01228721     History of Changes
Other Study ID Numbers: RNFL-Eyetracker-Foll
First Posted: October 26, 2010    Key Record Dates
Last Update Posted: October 26, 2010
Last Verified: October 2010