- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01027936
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
November 8, 2010 updated by: Topcon Corporation
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 Overview
Status
Unknown
Conditions
Study Type
Observational
Enrollment (Anticipated)
180
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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California
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La Jolla, California, United States, 92037
- Shiley Eye Center UCSD
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Kansas
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Overland Park, Kansas, United States, 66211
- Durrie Vision
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New York
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New York, New York, United States, 10003
- Glaucoma Associates of New York
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New York, New York, United States, 10036
- SUNY
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New York, New York, United States, 10022
- Vitreous-Retina-Macula Consultants of New York, P.C.
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Wisconsin
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Milwaukee, Wisconsin, United States, 53226
- Eye Institute/Medical College of WI
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
180 male and female volunteers from 6 centers with normal, healthy eyes form six age groups, aged 18 years or older.
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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Normal Healthy Volunteers
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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
|
12 Months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Robert Weinreb, M.D., University of California, San Diego; Shiley Eye Center
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
April 1, 2009
Primary Completion (Anticipated)
March 1, 2010
Study Completion (Anticipated)
November 1, 2010
Study Registration Dates
First Submitted
December 8, 2009
First Submitted That Met QC Criteria
December 8, 2009
First Posted (Estimate)
December 9, 2009
Study Record Updates
Last Update Posted (Estimate)
November 10, 2010
Last Update Submitted That Met QC Criteria
November 8, 2010
Last Verified
November 1, 2010
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- NDB-001
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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