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

Primary Purpose

Myopia

Status
Unknown status
Phase
Locations
United States
Study Type
Observational
Intervention
Sponsored by
National Eye Institute (NEI)
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an observational trial for Myopia

Eligibility Criteria

6 Years - 14 Years (Child)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • West Alabama Health Services, Inc.Recruiting
  • Southern California College of OptometryRecruiting
  • University of Houston, College of OptometryRecruiting

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
September 23, 1999
Last Updated
June 23, 2005
Sponsor
National Eye Institute (NEI)
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1. Study Identification

Unique Protocol Identification Number
NCT00000169
Brief Title
The Collaborative Longitudinal Evaluation of Ethnicity and Refractive Error (CLEERE) Study
Study Type
Observational

2. Study Status

Record Verification Date
June 2001
Overall Recruitment Status
Unknown status
Study Start Date
April 1999 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
National Eye Institute (NEI)

4. Oversight

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Myopia

7. Study Design

10. Eligibility

Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
14 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Lisa A. Jones, Ph.D.
Phone
1-614-292-7097
Email
jones.809@osu.edu
Facility Information:
Facility Name
West Alabama Health Services, Inc.
City
Eutaw
State/Province
Alabama
ZIP/Postal Code
35462
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sandral Hullett, MD, et al
Phone
205-372-3674
Email
kleinstein@icare.opt.uab.edu
Facility Name
Southern California College of Optometry
City
Fullerton
State/Province
California
ZIP/Postal Code
92831
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Julie A. Yu, OD
Phone
714-992-7806
Email
jyu@scco.edu
Facility Name
University of Houston, College of Optometry
City
Houston
State/Province
Texas
ZIP/Postal Code
77204-2020
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ruth E. Manny, OD PhD
Phone
713-743-1944
Email
rmanny@uh.edu

12. IPD Sharing Statement

Citations:
PubMed Identifier
1559777
Citation
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Citation
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PubMed Identifier
8807648
Citation
Walline JJ, Zadnik K, Mutti DO. Validity of surveys reporting myopia, astigmatism, and presbyopia. Optom Vis Sci. 1996 Jun;73(6):376-81. doi: 10.1097/00006324-199606000-00004.
Results Reference
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PubMed Identifier
8233371
Citation
Zadnik K, Mutti DO, Friedman NE, Adams AJ. Initial cross-sectional results from the Orinda Longitudinal Study of Myopia. Optom Vis Sci. 1993 Sep;70(9):750-8. doi: 10.1097/00006324-199309000-00012.
Results Reference
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PubMed Identifier
8158816
Citation
Zadnik K, Satariano WA, Mutti DO, Sholtz RI, Adams AJ. The effect of parental history of myopia on children's eye size. JAMA. 1994 May 4;271(17):1323-7.
Results Reference
background
PubMed Identifier
7634141
Citation
Zadnik K, Friedman NE, Mutti DO. Repeatability of corneal topography: the "corneal field". J Refract Surg. 1995 Mar-Apr;11(2):119-25. doi: 10.3928/1081-597X-19950301-12. Erratum In: J Refract Surg 1995 May-Jun;11(3):164.
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PubMed Identifier
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Citation
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Results Reference
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PubMed Identifier
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Citation
Zadnik K, Mutti DO, Fusaro RE, Adams AJ. Longitudinal evidence of crystalline lens thinning in children. Invest Ophthalmol Vis Sci. 1995 Jul;36(8):1581-7.
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PubMed Identifier
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Citation
Friedman NE, Zadnik K, Mutti DO, Fusaro RE. Quantifying corneal toricity from videokeratography with Fourier analysis. J Refract Surg. 1996 Jan-Feb;12(1):108-13. doi: 10.3928/1081-597X-19960101-20.
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Citation
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Citation
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Citation
Kleinstein RN, Mutti DO, Manny RE, Shin JA, Zadnik K. Cycloplegia in African-American children. Optom Vis Sci. 1999 Feb;76(2):102-7. doi: 10.1097/00006324-199902000-00017.
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PubMed Identifier
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Citation
Shin JA, Manny RE, Kleinstein RN, Mutti DO, Zadnik K. Short-term repeatability of hand-held keratometry measurements. Optom Vis Sci. 1999 Apr;76(4):247-53. doi: 10.1097/00006324-199904000-00029.
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Citation
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Citation
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PubMed Identifier
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Citation
Kleinstein RN, Mutti DO, Sinnott LT, Jones-Jordan LA, Cotter SA, Manny RE, Twelker JD, Zadnik K; Collaborative Longitudinal Evaluation of Ethnicity and Refractive Error (CLEERE) Study Group. Uncorrected Refractive Error and Distance Visual Acuity in Children Aged 6 to 14 Years. Optom Vis Sci. 2021 Jan 1;98(1):3-12. doi: 10.1097/OPX.0000000000001630.
Results Reference
derived

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

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