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

Sponsor
National Eye Institute (NEI) (NIH)
Overall Status
Unknown status
CT.gov ID
NCT00000169
Collaborator
(none)
3

Study Details

Study Description

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 Intervention/Treatment Phase

    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

    Study Type:
    Observational
    Study Start Date :
    Apr 1, 1999

    Outcome Measures

    Primary Outcome Measures

      Eligibility Criteria

      Criteria

      Ages Eligible for Study:
      6 Years to 14 Years
      Sexes Eligible for Study:
      All
      Accepts Healthy Volunteers:
      Yes

      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

      Locations

      Site City State Country Postal Code
      1 West Alabama Health Services, Inc. Eutaw Alabama United States 35462
      2 Southern California College of Optometry Fullerton California United States 92831
      3 University of Houston, College of Optometry Houston Texas United States 77204-2020

      Sponsors and Collaborators

      • National Eye Institute (NEI)

      Investigators

      None specified.

      Study Documents (Full-Text)

      None provided.

      More Information

      Publications

      Responsible Party:
      , ,
      ClinicalTrials.gov Identifier:
      NCT00000169
      Other Study ID Numbers:
      • NEI-72
      First Posted:
      Sep 24, 1999
      Last Update Posted:
      Jun 24, 2005
      Last Verified:
      Jun 1, 2001
      Additional relevant MeSH terms:

      Study Results

      No Results Posted as of Jun 24, 2005