An Age-Stratified Data Collection Study to Establish a Normative Database Using the 3D Optical Coherence Tomography 3D OCT-1000 Mark II
Withdrawn
- Conditions
- Healthy
- Registration Number
- NCT01027936
- Lead Sponsor
- Topcon Corporation
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- WITHDRAWN
- Sex
- All
- Target Recruitment
- 180
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 & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (6)
Durrie Vision
🇺🇸Overland Park, Kansas, United States
Glaucoma Associates of New York
🇺🇸New York, New York, United States
Shiley Eye Center UCSD
🇺🇸La Jolla, California, United States
SUNY
🇺🇸New York, New York, United States
Eye Institute/Medical College of WI
🇺🇸Milwaukee, Wisconsin, United States
Vitreous-Retina-Macula Consultants of New York, P.C.
🇺🇸New York, New York, United States