An Age-Stratified Data Collection Study to Establish a Normative Database Using the 3D Optical Coherence Tomography 3D OCT-1000 Mark II

Topcon

Status: Withdrawn

Conditions: Healthy

Study type: Observational

Funder types: Industry

Identifiers

NCT01027936

NDB-001

Details and patient eligibility

About

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.

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

0 participants in 1 patient group

Normal Healthy Volunteers