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:

Genetics Home Reference related topics: early-onset glaucoma

MedlinePlus related topics: Dietary Fiber Glaucoma

U.S. FDA Resources

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

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):

Langenegger SJ, Funk J, Töteberg-Harms M. Reproducibility of retinal nerve fiber layer thickness measurements using the eye tracker and the retest function of Spectralis SD-OCT in glaucomatous and healthy control eyes. Invest Ophthalmol Vis Sci. 2011 May 18;52(6):3338-44. Print 2011 May.

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 May 16, 2013

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