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The Collaborative Longitudinal Evaluation of Ethnicity and Refractive Error (CLEERE) Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00000169
Recruitment Status : Unknown
Verified June 2001 by National Eye Institute (NEI).
Recruitment status was:  Recruiting
First Posted : September 24, 1999
Last Update Posted : June 24, 2005
Sponsor:
Information provided by:
National Eye Institute (NEI)

Study Description
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Brief Summary:

To compare and contrast normal eye growth, ocular component development, and refractive error development in Hispanic, African-American, and Asian schoolchildren with what happens in Caucasian children from the Orinda Longitudinal Study of Myopia.

To investigate risk factors for the development of myopia.

To conduct DNA-based studies on nearsighted children and their families.


Condition or disease
Myopia

Detailed Description:

The Orinda Longitudinal Study of Myopia (OLSM) was started in 1989 to investigate normal eye growth and the development of myopia in over 1,200 school-aged children to date. Beginning in 1997, three parallel study phases are being conducted. Phase 1 investigates additional factors that may predict the onset of juvenile myopia (accommodative function, peripheral refractive error, intraocular pressure, and school achievement). Phase 2 compares and contrasts the optical ocular components and refractive error profiles of other ethnic groups with the predominantly Caucasian Orinda database. Phase 3 conducts DNA-based studies on the prevalent OLSM myopes and their families to use these phenotypically well-characterized children and a panel of candidate genes to look for evidence of genetic factors. In parallel with the candidate gene association, family material is used in an allele sharing approach to identify loci using highly variable, PCR-based markers.

In Phase 1 we continue to examine Orinda Union School District children in grades 1 through 8 (ages 6 through 14 years) annually. The measurement of accommodative response, accommodative lag, phoria, response AC/A ratio, peripheral refractive error, and intraocular pressure will be added to the existing protocol, and photokeratoscopy and two measures of tonic accommodation will be eliminated to minimize respondent burden. Parents of children in the study will be contacted for their permission to release school achievement data (Iowa Test of Basic Skills).

Phase 2 adds a major component by adding three clinical centers to assess the influence of ethnicity on normal ocular and refractive error development. Children in these three are examined annually with initial enrollment in all grades from 1 through 8 using the revised OLSM protocol as described above.

Increased prevalence of myopia among children of myopic parents, twin studies, segregation analysis, and our own preliminary analyses from the OLSM support a genetic etiologic component for myopia. In phase 3, we use the phenotypic characterization of children in the Orinda Longitudinal Study of Myopia to identify prevalent cases of myopia and their families. These well-defined phenotypic myopes and non-myopic siblings and their parents are being explored, seeking to develop a panel of candidate genes for myopia and to conduct an allele sharing analysis in these families

The Collaborative Longitudinal Evaluation of Ethnicity and Refractive Error (CLEERE) Study is a multi-center, observational investigation of ocular development and refractive error development in schoolchildren. It adds three clinical centers to the Orinda Longitudinal Study of Myopia (OLSM), begun in 1989, specifically to describe normal ocular growth in children ages 6 to 14 years, and to develop the ability to predict juvenile onset myopia before it is clinically evident. In addition to the more than 1,300 predominantly Caucasian children enrolled in the OLSM, three additional clinical sites enroll African-American, Hispanic, and Asian children. The children are examined annually for at least four years. Examinations include visual acuity, refraction by a variety of methods (cycloplegic autorefraction being the primary outcome measure), cover test at distance and near, accommodative response assessment with the autorefractor, response AC/A ratio measurement, videophakometry, peripheral refraction, and A-scan ultrasonography.

Patients are examined at 4 clinical centers. The clinical centers have enrolled 3,493 patients as of April 28, 1999.

Study Design
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Study Type : Observational
Study Start Date : April 1999

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Outcome Measures
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Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   6 Years to 14 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria
Children were eligible if they were enrolled in the first through eighth grades in selected schools in Eutaw, Alabama; Houston, Texas; Orinda, California; or Irvine, California in the 1997-98 academic year and in the first grade only in Eutaw, Houston, and Irvine in the 1998-99 academic year.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00000169


Contacts
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Contact: Lisa A. Jones, Ph.D. 1-614-292-7097 jones.809@osu.edu

Locations
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United States, Alabama
West Alabama Health Services, Inc. Recruiting
Eutaw, Alabama, United States, 35462
Contact: Sandral Hullett, MD, et al    205-372-3674    kleinstein@icare.opt.uab.edu   
United States, California
Southern California College of Optometry Recruiting
Fullerton, California, United States, 92831
Contact: Julie A. Yu, OD    714-992-7806    jyu@scco.edu   
United States, Texas
University of Houston, College of Optometry Recruiting
Houston, Texas, United States, 77204-2020
Contact: Ruth E. Manny, OD PhD    713-743-1944    rmanny@uh.edu   
Sponsors and Collaborators
National Eye Institute (NEI)
More Information
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Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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ClinicalTrials.gov Identifier: NCT00000169    
Other Study ID Numbers: NEI-72
First Posted: September 24, 1999    Key Record Dates
Last Update Posted: June 24, 2005
Last Verified: June 2001
Additional relevant MeSH terms:
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Myopia
Refractive Errors
Eye Diseases