Correction of Farsightedness in Children Study

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

58 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-11-30

Study Completion Date

2008-03-31

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.

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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.

Conditions

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Hyperopia Farsightedness

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Spectacles

Spectacles with hyperopic lenses

Group Type EXPERIMENTAL

Spectacles

Intervention Type DEVICE

Hyperopic spectacle lenses

Control

Spectacles with placebo lenses

Group Type PLACEBO_COMPARATOR

Control

Intervention Type DEVICE

Plano (no power, control) spectacle lenses

Interventions

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Spectacles

Hyperopic spectacle lenses

Intervention Type DEVICE

Control

Plano (no power, control) spectacle lenses

Intervention Type DEVICE

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)

Minimum Eligible Age

6 Years

Maximum Eligible Age

11 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes