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Optical Coherence Tomography (OCT) Data Collection Study

This study has been completed.
Information provided by (Responsible Party):
Heidelberg Engineering GmbH Identifier:
First received: July 13, 2012
Last updated: October 26, 2016
Last verified: September 2016
Collect OCT data to evaluate the range and age trend of ocular measurements.


Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Optical Coherence Tomography (OCT) Data Collection Study "S-2012-1 Norm-cc"

Resource links provided by NLM:

Further study details as provided by Heidelberg Engineering GmbH:

Primary Outcome Measures:
  • Primary Endpoints [ Time Frame: 3 months ]
    The primary endpoints are the structural measurement values of (1) the ONH, (2) the peri-papillary RNFL, and (3) the macula obtained using the Spectralis OCT and the statistical descriptors such as mean, standard deviation, and distribution percentiles.

  • Bruch's Membrane Opening - Minimum Rim Area, Global [ Time Frame: 3 months ]

Enrollment: 303
Study Start Date: July 2012
Study Completion Date: December 2012
Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
No eye disease.

Detailed Description:
This is a prospective, multi-center study. Ocular history and examination will be conducted on consented subjects to determine further participation in the study. Subjects qualified to continue will undergo imaging of both eyes using the SPECTRALIS OCT.

Ages Eligible for Study:   18 Years to 90 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
No eye disease.

Inclusion Criteria:

  • Subject is not an employee of the eye clinic.
  • Age ≥18 to 90.
  • Able and willing to undergo the test procedures, give consent, and to follow instructions.
  • Healthy eye without prior intraocular surgery (except cataract surgery and Lasik) and without clinically significant vitreal, retinal or choroidal diseases, diabetic retinopathy, or disease of the optic nerve.
  • Caucasian decent (self-reported).
  • Negative history of glaucoma.
  • Intraocular pressure ≤21mmHg.
  • Best corrected visual acuity ≥0.5.
  • Refraction between +6 and -6 diopters and astigmatism ≤ 2 diopters.
  • Normal visual field with Glaucoma Hemifield Test and Mean Deviation within normal limits.
  • Clinically normal appearance of the optic disc, with normal appearing neuroretinal rim with respect to color and shape. The optic disc is examined ophthalmoscopically and by evaluation of stereo photographs.
  • When both eyes are eligible, both eyes enter the study for inter-eye asymmetry; one randomly selected eye will be used for all other measures.

Exclusion Criteria:

  • Unreliable visual field. The reliability indices should be used as guide as well as the perimetrist's notes.
  • Unusable disc stereo photos.
  • Inability to undergo the tests.
  • Insufficient quality of Spectralis OCT images (this is not determined until after Spectralis OCT examination, and is an unusual circumstance). Minimum requirements are:

    • Retina completely included in image frame,
    • Quality Score ≥ 20 in the stored ART mean images, and
    • For ONH-R scan: Center position error ≤ 100 μm.
  • Note: Inability of a subject to perform one of the two scan patterns or insufficient image quality in one scan pattern does not exclude the subject or eye from the study.
  Contacts and Locations
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Please refer to this study by its identifier: NCT01641835

Canada, Nova Scotia
Dalhousie University
Halifax, Nova Scotia, Canada, B3H 2Y9
Sponsors and Collaborators
Heidelberg Engineering GmbH
Principal Investigator: Balwantray Chauhan, PhD Dalhousie University, Halifax, NS, Canada
Principal Investigator: Claude Burgoyne, MD Devers Eye Institute, Portland, OR, USA
Principal Investigator: Christopher Girkin, MD Callahan Eye Foundation Hospital, Birmingham, AL, USA
Principal Investigator: Christian Mardin, MD Augenklinik des Universitätsklinikums Erlangen, Erlangen, Germany
Principal Investigator: Alexander Scheuerle, MD Universitätsaugenklinik, Heidelberg, Germany
  More Information

Responsible Party: Heidelberg Engineering GmbH Identifier: NCT01641835     History of Changes
Other Study ID Numbers: S-2012-1 NORM-cc
Study First Received: July 13, 2012
Results First Received: August 1, 2014
Last Updated: October 26, 2016 processed this record on April 28, 2017