Ignite Creation Date:
2024-05-05 @ 10:00 AM
Last Modification Date:
2024-10-26 @ 9:01 AM
Study NCT ID:
NCT00000169
Status:
UNKNOWN
Last Update Posted:
2005-06-24
First Post:
1999-09-23
Brief Title:
The Collaborative Longitudinal Evaluation of Ethnicity and Refractive Error CLEERE Study
Sponsor:
National Eye Institute NEI
Organization:
National Eye Institute NEI
Study Overview
Official Title:
None
Status:
UNKNOWN
Status Verified Date:
2001-06
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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 1200 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 ACA 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 1300 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 ACA ratio measurement videophakometry peripheral refraction and A-scan ultrasonography
Patients are examined at 4 clinical centers The clinical centers have enrolled 3493 patients as of April 28 1999
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 ACA 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 1300 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 ACA ratio measurement videophakometry peripheral refraction and A-scan ultrasonography
Patients are examined at 4 clinical centers The clinical centers have enrolled 3493 patients as of April 28 1999
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None