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
The recruitment status of this study is unknown because the information has not been verified recently.
Verified November 2010 by Topcon Corporation.
Recruitment status was Active, not recruiting
Information provided by:
First received: December 8, 2009
Last updated: November 8, 2010
Last verified: November 2010
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.
||Observational Model: Case Control
Time Perspective: Prospective
||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
Primary Outcome Measures:
- 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 ] [ Designated as safety issue: No ]
| Estimated Enrollment:
| Study Start Date:
| Estimated Study Completion Date:
| Estimated Primary Completion Date:
||March 2010 (Final data collection date for primary outcome measure)
Normal Healthy Volunteers
|Ages Eligible for Study:
||18 Years and older
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
180 male and female volunteers from 6 centers with normal, healthy eyes form six age groups, aged 18 years or older.
- 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.
- 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.
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01027936
|Shiley Eye Center UCSD
|La Jolla, California, United States, 92037 |
|Overland Park, Kansas, United States, 66211 |
|Vitreous-Retina-Macula Consultants of New York, P.C.
|New York, New York, United States, 10022 |
|New York, New York, United States, 10036 |
|Glaucoma Associates of New York
|New York, New York, United States, 10003 |
|Eye Institute/Medical College of WI
|Milwaukee, Wisconsin, United States, 53226 |
||Robert Weinreb, M.D.
||University of California, San Diego; Shiley Eye Center
No publications provided
||Bob Gibson/Senior Director of Marketing and Strategic Planning, Topcon Medical Systems, Inc.
History of Changes
|Other Study ID Numbers:
|Study First Received:
||December 8, 2009
||November 8, 2010
||United States: Institutional Review Board
Keywords provided by Topcon Corporation:
ClinicalTrials.gov processed this record on October 19, 2014