Correction of Farsightedness in Children Study (CHICS)
Hyperopia (farsightedness) has been reported to be associated with reduced visual perceptual and reading abilities. However, there is controversy regarding whether or not to prescribe for low to moderate amounts of hyperopia. The Correction of Hyperopia In Children Study (CHICS) is a placebo-controlled, randomized, masked investigation of the effect of spectacle correction for moderate amounts of hyperopia on visual function, symptoms, attention, and reading skills in children.
Device: Glasses for the correction of low to moderate farsightedness
Device: Glasses with placebo lens
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||Correction of Hyperopia in Children Study|
- Reading ability [ Time Frame: 6 week primary outcome ] [ Designated as safety issue: No ]Reading ability as measured by the Kaufman Test of Educational Achievement (K-TEA).
- Attention [ Time Frame: 6 week primary outcome ] [ Designated as safety issue: No ]Attention as measured by the Cognitive Assessment System.
- Symptoms [ Time Frame: 6 week primary outcome ] [ Designated as safety issue: No ]Improvement in symptoms as measured by a standardized questionnaire.
- Visual ability [ Time Frame: 6 week primary outcome ] [ Designated as safety issue: No ]Improvement in accommodative and/or vergence function.
|Study Start Date:||November 2003|
|Study Completion Date:||March 2008|
|Primary Completion Date:||March 2008 (Final data collection date for primary outcome measure)|
Spectacles with hyperopic lenses
|Device: Glasses for the correction of low to moderate farsightedness|
Placebo Comparator: Control
Spectacles with placebo lenses
|Device: Glasses with placebo lens|
Please refer to this study by its ClinicalTrials.gov identifier: NCT00472212
|United States, Illinois|
|Illinois College of Optometry/Illinois Eye Institute|
|Chicago, Illinois, United States, 60616|
|United States, New York|
|SUNY College of Optometry/University Optometric Center|
|New York, New York, United States, 10036|
|United States, Ohio|
|The Ohio State University|
|Columbus, Ohio, United States, 43210|
|United States, Tennessee|
|Southern College of Optometry|
|Memphis, Tennessee, United States, 38104|
|Principal Investigator:||Marjean Kulp, OD, MS||Ohio State University|