Overview

This trial is active, not recruiting.

Condition healthy
Phase phase 4
Sponsor Topcon Corporation
Start date April 2009
End date March 2010
Trial size 180 participants
Trial identifier NCT01027936, NDB-001

Summary

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.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Observational model case control
Time perspective prospective
Arm

Primary Outcomes

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

Eligibility Criteria

Male or female participants at least 18 years old.

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.

Additional Information

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
Trial information was received from ClinicalTrials.gov and was last updated in November 2010.
Information provided to ClinicalTrials.gov by Topcon Corporation.