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
  Purpose

Collect OCT data to evaluate the range and age trend of ocular measurements.


Condition
Glaucoma.

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 ] [ 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.


Enrollment: 322
Study Start Date: July 2012
Study Completion Date: December 2012
Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts
Normals
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.

  Eligibility

Ages Eligible for Study:   18 Years to 90 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01641835

Locations
Canada, Nova Scotia
Dalhousie University
Halifax, Nova Scotia, Canada, B3H 2Y9
Sponsors and Collaborators
Heidelberg Engineering GmbH
Investigators
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

No publications provided

Responsible Party: Heidelberg Engineering GmbH
ClinicalTrials.gov Identifier: NCT01641835     History of Changes
Other Study ID Numbers: S-2012-1 NORM-cc
Study First Received: July 13, 2012
Last Updated: July 3, 2013
Health Authority: United States: Food and Drug Administration
Canada: Health Canada
Germany: Federal Institute for Drugs and Medical Devices

Additional relevant MeSH terms:
Glaucoma
Ocular Hypertension
Eye Diseases

ClinicalTrials.gov processed this record on July 28, 2014