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Optical Coherence Tomography (OCT) Data Collection Study

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Heidelberg Engineering GmbH
ClinicalTrials.gov Identifier:
NCT01641835
First received: July 13, 2012
Last updated: July 3, 2013
Last verified: July 2013

July 13, 2012
July 3, 2013
July 2012
December 2012   (final data collection date for primary outcome measure)
Primary Endpoints [ Time Frame: 3 months ] [ Designated as safety issue: No ]
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.
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Complete list of historical versions of study NCT01641835 on ClinicalTrials.gov Archive Site
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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
Observational Model: Case-Only
Time Perspective: Prospective
Not Provided
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Non-Probability Sample

No eye disease.

Glaucoma.
Not Provided
Normals
No eye disease.
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
322
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.
Both
18 Years to 90 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Canada
 
NCT01641835
S-2012-1 NORM-cc
Yes
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
July 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP