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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 because the information has not been verified recently.
Verified November 2010 by Topcon Corporation.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
Topcon Corporation
ClinicalTrials.gov Identifier:
NCT01027936
First received: December 8, 2009
Last updated: November 8, 2010
Last verified: November 2010

December 8, 2009
November 8, 2010
April 2009
March 2010   (final data collection date for primary outcome measure)
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 ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01027936 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
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
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

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.

Not Provided
Observational
Observational Model: Case Control
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample

180 male and female volunteers from 6 centers with normal, healthy eyes form six age groups, aged 18 years or older.

Healthy
Not Provided
Normal Healthy Volunteers
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
180
November 2010
March 2010   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01027936
NDB-001
No
Bob Gibson/Senior Director of Marketing and Strategic Planning, Topcon Medical Systems, Inc.
Topcon Corporation
Not Provided
Study Director: Robert Weinreb, M.D. University of California, San Diego; Shiley Eye Center
Topcon Corporation
November 2010

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