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
  Purpose

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
Healthy
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 ] [ Designated as safety issue: No ]

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)
Groups/Cohorts
Normal Healthy Volunteers

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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.

Criteria

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
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: NCT01027936

Locations
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
SUNY
New York, New York, United States, 10036
Vitreous-Retina-Macula Consultants of New York, P.C.
New York, New York, United States, 10022
United States, Wisconsin
Eye Institute/Medical College of WI
Milwaukee, Wisconsin, United States, 53226
Sponsors and Collaborators
Topcon Corporation
Investigators
Study Director: Robert Weinreb, M.D. University of California, San Diego; Shiley Eye Center
  More Information

No publications provided

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

Keywords provided by Topcon Corporation:
Healthy Volunteers

ClinicalTrials.gov processed this record on October 21, 2014