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.

Study Overview

• Status: Unknown
• Conditions: Healthy

• Study Type: Observational
• Enrollment (Anticipated): 180

Contacts and Locations

Study Locations

• United States
  • California
    • La Jolla, California, United States, 92037
      • Shiley Eye Center UCSD
  • Kansas
    • Overland Park, Kansas, United States, 66211
      • Durrie Vision
  • New York
    • New York, New York, United States, 10003
      • Glaucoma Associates of New York
    • New York, New York, United States, 10036
      • SUNY
    • New York, New York, United States, 10022
      • Vitreous-Retina-Macula Consultants of New York, P.C.
  • Wisconsin
    • Milwaukee, Wisconsin, United States, 53226
      • Eye Institute/Medical College of WI

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• 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.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Normal Healthy Volunteers

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Topcon Corporation
• Investigators: Study Director: Robert Weinreb, M.D., University of California, San Diego; Shiley Eye Center

Study record dates

Study Major Dates

• Study Start: April 1, 2009
• Primary Completion (Anticipated): March 1, 2010
• Study Completion (Anticipated): November 1, 2010

Study Registration Dates

• First Submitted: December 8, 2009
• First Submitted That Met QC Criteria: December 8, 2009
• First Posted (Estimate): December 9, 2009

Study Record Updates

• Last Update Posted (Estimate): November 10, 2010
• Last Update Submitted That Met QC Criteria: November 8, 2010
• Last Verified: November 1, 2010

More Information

Terms related to this study

• Keywords: Healthy Volunteers
• Other Study ID Numbers: NDB-001