NCT01027936
Withdrawn
Not Applicable
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
ConditionsHealthy
Overview
- Phase
- Not Applicable
- Status
- Withdrawn
- Sponsor
- Topcon Corporation
- Enrollment
- 180
- Locations
- 6
- Primary Endpoint
- A normative dataset containing a statistical description of expected norms of retinal nerve fiber layer (RNFL) and macula lutea thickness, stratified by age.
Overview
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.
Study Design
- Study Type
- Observational
- Observational Model
- Case Control
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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.
Outcomes
Primary Outcomes
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
Secondary Outcomes
No secondary outcomes reported
Investigators
Study Sites (6)
Loading locations...
Similar Trials
Completed
Not Applicable
Optical Coherence Tomography (OCT) Data Collection StudyNo Eye DiseaseNCT01459731Optovue400
Completed
Not Applicable
Seven Year Update of Macular Degeneration PatientsAge-related Macular DegenerationNCT01256827University of California, San Francisco65
Completed
Not Applicable
Optical Coherence Tomography (OCT) Data Collection StudyGlaucomaNCT01641835Heidelberg Engineering GmbH303
Completed
Not Applicable
Research on age-related macular degeneration and diabetic complications using non-invasive AGEs measurement equipment.age-related macular degeneration, diabetic retinopathyJPRN-UMIN000010741Shinshu University Graduate School of Medicine, Department of Ophthalmology500
Completed
Not Applicable
Dynamic Light Scattering for Studying Lens Aging and Cataract FormationCataractNCT00081991National Eye Institute (NEI)267