Correction of Farsightedness in Children Study

Study Overview
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Brief Summary
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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
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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.

Official Title
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Correction of Hyperopia in Children Study

Conditions
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Hyperopia, Farsightedness

Intervention / Treatment
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* Device: Spectacles
* Device: Control


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 6 Years
Maximum Age: 11 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Spectacles<br>Spectacles with hyperopic lenses | Device: Spectacles<br>* Hyperopic spectacle lenses<br>|
| Placebo Comparator: Control<br>Spectacles with placebo lenses | Device: Control<br>* Plano (no power, control) spectacle lenses<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | 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. | 6 week outcome exam | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Cognitive Assessment System (CAS) Attention Scores as Measured From Baseline to After 6 Weeks of Assigned Treatment (Hyperopic or Control Correction) | Individually administered battery designed to measure cognitive processing abilities. CAS is based on PASS (Planning, Attention, Simultaneous, and Successive), a well-researched cognitive/neuropsychological theory. A higher score indicates a better outcome. | 6 week outcome exam | 
| Change in Accommodative Response From Baseline to After 6 Weeks of Assigned Treatment (Hyperopic or Control Correction) | Accommodative response, Right eye. This is a measure the accuracy of focusing (accommodative accuracy or response) while the subject views a near target. Lower (positive) values represent better accuracy of focusing. | 6 week outcome exam |