Optical Coherence Tomography (OCT) Data Collection Study

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: NCT01641835
Recruitment Status : Completed
First Posted : July 17, 2012
Results First Posted : December 19, 2016
Last Update Posted : December 19, 2016
Information provided by (Responsible Party):
Heidelberg Engineering GmbH

July 13, 2012
July 17, 2012
August 1, 2014
December 19, 2016
December 19, 2016
July 2012
December 2012   (Final data collection date for primary outcome measure)
  • 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 ]
Not Provided
Complete list of historical versions of study NCT01641835 on Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
Optical Coherence Tomography (OCT) Data Collection Study
Optical Coherence Tomography (OCT) Data Collection Study "S-2012-1 Norm-cc"
Collect OCT data to evaluate the range and age trend of ocular measurements.
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.
Observational Model: Case-Only
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample
No eye disease.
Not Provided
No eye disease.
Not Provided

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
December 2012
December 2012   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
18 Years to 90 Years   (Adult, Senior)
Contact information is only displayed when the study is recruiting subjects
S-2012-1 NORM-cc
Not Provided
Not Provided
Heidelberg Engineering GmbH
Heidelberg Engineering GmbH
Not Provided
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
Heidelberg Engineering GmbH
September 2016