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
Recruitment status was Active, not recruiting
Sponsor:
Topcon Corporation
Information provided by:
Topcon Corporation
ClinicalTrials.gov Identifier:
NCT01027936
First received: December 8, 2009
Last updated: November 8, 2010
Last verified: November 2010
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Purpose
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 Type: | Observational |
| Study Design: | Observational Model: Case Control Time Perspective: Prospective |
| Official Title: | 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 |
Further study details as provided by Topcon Corporation:
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: | 180 |
| Study Start Date: | April 2009 |
| Estimated Study Completion Date: | November 2010 |
| Estimated Primary Completion Date: | March 2010 (Final data collection date for primary outcome measure) |
| Groups/Cohorts |
|---|
| Normal Healthy Volunteers |
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
| 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.
Criteria
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.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01027936
Locations
| United States, California | |
| Shiley Eye Center UCSD | |
| La Jolla, California, United States, 92037 | |
| United States, Kansas | |
| Durrie Vision | |
| Overland Park, Kansas, United States, 66211 | |
| United States, New York | |
| Vitreous-Retina-Macula Consultants of New York, P.C. | |
| New York, New York, United States, 10022 | |
| SUNY | |
| New York, New York, United States, 10036 | |
| Glaucoma Associates of New York | |
| New York, New York, United States, 10003 | |
| United States, Wisconsin | |
| Eye Institute/Medical College of WI | |
| Milwaukee, Wisconsin, United States, 53226 | |
Sponsors and Collaborators
Topcon Corporation
Investigators
| Study Director: | Robert Weinreb, M.D. | University of California, San Diego; Shiley Eye Center |
More Information
No publications provided
| Responsible Party: | Bob Gibson/Senior Director of Marketing and Strategic Planning, Topcon Medical Systems, Inc. |
| ClinicalTrials.gov Identifier: | NCT01027936 History of Changes |
| Other Study ID Numbers: | NDB-001 |
| Study First Received: | December 8, 2009 |
| Last Updated: | November 8, 2010 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Topcon Corporation:
|
Healthy Volunteers |
ClinicalTrials.gov processed this record on May 16, 2013