Correction of Farsightedness in Children Study (CHICS)

The Ohio State University

Status: Completed

Conditions: Farsightedness; Hyperopia

Treatments: Device: Spectacles; Device: Control

Study type: Interventional

Funder types: Other

Identifiers

NCT00472212

2001H0401

Details and patient eligibility

About

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.

Full 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.

Enrollment: 58 patients

Sex: All

Ages: 6 to 11 years old

Volunteers: Accepts Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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58 participants in 2 patient groups, including a placebo group

Spectacles

Experimental group

Description:

Spectacles with hyperopic lenses

Treatment:

Device: Spectacles

Control

Placebo Comparator group

Description:

Spectacles with placebo lenses

Treatment:

Device: Control