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

This study has been terminated.
Sponsor:
Information provided by:
University of Zurich
ClinicalTrials.gov Identifier:
NCT01228721
First received: October 25, 2010
Last updated: NA
Last verified: October 2010
History: No changes posted
  Purpose

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

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic

Resource links provided by NLM:


Further study details as provided by University of Zurich:

Primary Outcome Measures:
  • retinal nerve fiber layer thickness measurement

Study Start Date: January 2009
Estimated Study Completion Date: December 2010
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01228721

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: NCT01228721     History of Changes
Other Study ID Numbers: RNFL-Eyetracker-Foll
Study First Received: October 25, 2010
Last Updated: October 25, 2010
Health Authority: Switzerland: Swissmedic

Additional relevant MeSH terms:
Glaucoma
Ocular Hypertension
Eye Diseases

ClinicalTrials.gov processed this record on August 26, 2014