Correction of Hyperopia in Children Study
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Ohio State University
- Enrollment
- 58
- Locations
- 4
- Primary Endpoint
- Change in Kaufman Test of Educational Achievement (K-TEA) Reading Comprehension Score as Measured From Baseline to After 6 Weeks of Assigned Treatment (Hyperopic or Control Correction)
Study Overview
Brief Summary
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, attention, and reading skills in children.
Detailed Description
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, attention, and reading skills in children.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 6 Years to 11 Years (Child)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Age 6-11 years;
- •At least +1.00D Hyperopia (farsightedness);
- •< +4.00D Hyperopia;
- •< 1.00D Astigmatism;
- •< 1.00D Anisometropia (difference between the two eyes);
- •Willing to be randomized;
- •Best corrected visual acuity of 20/25 or better in each eye;
- •Willing to wear eyeglasses full-time;
- •Willing to return for follow-up visits
Exclusion Criteria
- •Previous wear of glasses or contacts for farsightedness/hyperopia;
- •Eye disease that affects visual function;
- •Amblyopia (lazy eye);
- •Strabismus (eye turn);
- •History of strabismus surgery;
- •Chronic use of any of the following medications:
- •Antianxiety agents (Librium, Valium)
- •Antiarrythmic agents (Cifenline, Cibenzoline)
- •Anticholinergics (Motion sickness patch - scopolamine)
- •Bladder spasmolytic (Propiverine)
- •Chloroquine
- •Phenothiazines (Compazine, Mellaril, Thorazine)
- •Tricyclic antidepressants (Elavil, Nortriptyline, Tofranil)
Arms & Interventions
Spectacles
Spectacles with hyperopic lenses
Intervention: Spectacles (Device)
Control
Spectacles with placebo lenses
Intervention: Control (Device)
Outcomes
Primary Outcomes
Change in Kaufman Test of Educational Achievement (K-TEA) Reading Comprehension Score as Measured From Baseline to After 6 Weeks of Assigned Treatment (Hyperopic or Control Correction)
Time Frame: 6 week outcome exam
The Kaufman Test of Educational Achievement (K-TEA) was used to measure change in reading skill (reading comprehension). The K-TEA is a well-established, individually administered, standardized test for assessment of achievement in reading, with a mean standard score of 100 and standard deviation of 15. Higher values represent better performance.
Secondary Outcomes
- Change in Cognitive Assessment System (CAS) Attention Scores as Measured From Baseline to After 6 Weeks of Assigned Treatment (Hyperopic or Control Correction)(6 week outcome exam)
- Change in Accommodative Response From Baseline to After 6 Weeks of Assigned Treatment (Hyperopic or Control Correction)(6 week outcome exam)
Investigators
Marjean Kulp
Professor
Ohio State University