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An Age-Stratified Data Collection Study in Adult Males and Females, Ages 18 and Above to Establish a Normative Database Using the 3D Optical Coherence Tomography 3D OCT-1000 Mark II

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified November 2010 by Topcon Corporation.
Recruitment status was:  Active, not recruiting
Information provided by:
Topcon Corporation Identifier:
First received: December 8, 2009
Last updated: November 8, 2010
Last verified: November 2010
To collect three dimensional retinal measurements of the optic disc and the macula lutea on healthy normal subjects using the 3D OCT-1000 Mark II for the purpose of developing a normative database that is stratified by age.

Condition Phase
Phase 4

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: An Age-Stratified Data Collection Study in Adult Males and Females, Ages 18 and Above to Establish a Normative Database Using the 3D Optical Coherence Tomography 3D OCT-1000 Mark II

Further study details as provided by Topcon Corporation:

Primary Outcome Measures:
  • A normative dataset containing a statistical description of expected norms of retinal nerve fiber layer (RNFL) and macula lutea thickness, stratified by age. [ Time Frame: 12 Months ]

Estimated Enrollment: 180
Study Start Date: April 2009
Estimated Study Completion Date: November 2010
Estimated Primary Completion Date: March 2010 (Final data collection date for primary outcome measure)
Normal Healthy Volunteers


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
180 male and female volunteers from 6 centers with normal, healthy eyes form six age groups, aged 18 years or older.

Inclusion Criteria:

  • Male and Females at least 18 years of age;
  • Must be a member of one of the 3 ethnic groups: Caucasian, Hispanic or African American. Asians, Eastern Indians, and Native Americans have been excluded from this study;
  • Signed, written informed consent obtained for the study;
  • BSCVA of 20/40 or better in both eyes;
  • Intraocular pressure (IOP) ≤ 21 mm Hg in both eyes.

Exclusion Criteria:

  • Ocular disease;
  • Cataract on slit lamp exam with a corresponding loss of BSCVA worse than 20/25;
  • Corneal surface disruption precluding imaging;
  • Prior ocular surgery except uncomplicated phacoemulsification or strabismus surgery;
  • Prior corneal refractive surgery of any type;
  • Family history of glaucoma among first generation relatives;
  • Current history of an acute or chronic disease or illness that would confound the normative outcome(s) of the study;
  • Current use of systemic medications that may confound the outcome of the study;
  • Nystagmus or any other condition that would prevent a steady gaze during study tests or measurements;
  • Current history of inflammation or infection of the eye or eyelids; injury to the eye.
  Contacts and Locations
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Please refer to this study by its identifier: NCT01027936

United States, California
Shiley Eye Center UCSD
La Jolla, California, United States, 92037
United States, Kansas
Durrie Vision
Overland Park, Kansas, United States, 66211
United States, New York
Glaucoma Associates of New York
New York, New York, United States, 10003
Vitreous-Retina-Macula Consultants of New York, P.C.
New York, New York, United States, 10022
New York, New York, United States, 10036
United States, Wisconsin
Eye Institute/Medical College of WI
Milwaukee, Wisconsin, United States, 53226
Sponsors and Collaborators
Topcon Corporation
Study Director: Robert Weinreb, M.D. University of California, San Diego; Shiley Eye Center
  More Information

Responsible Party: Bob Gibson/Senior Director of Marketing and Strategic Planning, Topcon Medical Systems, Inc. Identifier: NCT01027936     History of Changes
Other Study ID Numbers: NDB-001
Study First Received: December 8, 2009
Last Updated: November 8, 2010

Keywords provided by Topcon Corporation:
Healthy Volunteers processed this record on May 24, 2017