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Completed

NCT Number: NCT00472212

Correction of Farsightedness in Children Study

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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Key information

Conditions

Hyperopia Eye Diseases Farsightedness Refractive Errors

Age range

6 year–11 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Illinois College of Optometry/Illinois Eye Institute, Chicago, Illinois, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Spectacles

Device

Hyperopic spectacle lenses

Control

Device

Plano (no power, control) spectacle lenses

Primary outcomes

  1. 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

  1. Change in Cognitive Assessment System (CAS) Attention Scores as Measured From Baseline to After 6 Weeks of Assigned Treatment (Hyperopic or Control Correction)

    Time frame: 6 week outcome exam

    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.

  2. Change in Accommodative Response From Baseline to After 6 Weeks of Assigned Treatment (Hyperopic or Control Correction)

    Time frame: 6 week outcome exam

    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.

Sponsors and collaborators

Lead sponsor

Ohio State University

Other

Collaborators

  • American Academy of Optometry
  • College of Optometrists in Vision Development
  • Ohio Lions Eye Research Foundation
  • SUNY Research Foundation
  • Transitions

Registry information

Official study title

Correction of Hyperopia in Children Study

Acronym: CHICS

Important dates

Study start
2003
Primary completion
2008
Study completion
2008
First posted
May 11, 2007
Registry last updated
Apr 18, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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