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

Withdrawn before enrolling

Conditions studied: Healthy

In brief

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.

Key facts

Study ID

NCT01027936

Run by

Topcon Corporation

People needed

0

Starts

2009-04-30

Expected to finish

2009-04-30

Last updated by the study team

2024-12-13

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

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

Full record on ClinicalTrials.gov

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