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Optical Coherence Tomography (OCT) Data Collection Study

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

Study Description
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Brief Summary:
Collect OCT data to evaluate the range and age trend of ocular measurements.

Condition or disease
Glaucoma

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.
Study Design
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Study Type : Observational
Actual Enrollment : 303 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Optical Coherence Tomography (OCT) Data Collection Study "S-2012-1 Norm-cc"
Study Start Date : July 2012
Actual Primary Completion Date : December 2012
Actual Study Completion Date : December 2012

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Groups and Cohorts
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Group/Cohort
Normals
No eye disease.


Outcome Measures
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Primary Outcome Measures :
  1. 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.

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

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

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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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01641835


Locations
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Canada, Nova Scotia
Dalhousie University
Halifax, Nova Scotia, Canada, B3H 2Y9
Sponsors and Collaborators
Heidelberg Engineering GmbH
Investigators
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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
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Responsible Party: Heidelberg Engineering GmbH
ClinicalTrials.gov Identifier: NCT01641835    
Other Study ID Numbers: S-2012-1 NORM-cc
First Posted: July 17, 2012    Key Record Dates
Results First Posted: December 19, 2016
Last Update Posted: December 19, 2016
Last Verified: September 2016
Additional relevant MeSH terms:
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Glaucoma
Ocular Hypertension
Eye Diseases