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Correction of Farsightedness in Children Study (CHICS)

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ClinicalTrials.gov Identifier: NCT00472212
Recruitment Status : Completed
First Posted : May 11, 2007
Last Update Posted : October 16, 2014
Sponsor:
Collaborators:
American Academy of Optometry
Transitions
Ohio Lions Eye Research Foundation
College of Optometrists in Vision Development
SUNY Research Foundation
Information provided by (Responsible Party):
Marjean Kulp, Ohio State University

Brief Summary:
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, symptoms, attention, and reading skills in children.

Condition or disease Intervention/treatment Phase
Hyperopia Farsightedness Device: Glasses for the correction of low to moderate farsightedness Device: Glasses with placebo lens Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 48 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Correction of Hyperopia in Children Study
Study Start Date : November 2003
Actual Primary Completion Date : March 2008
Actual Study Completion Date : March 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Eye Wear
U.S. FDA Resources

Arm Intervention/treatment
Experimental: Spectacles
Spectacles with hyperopic lenses
Device: Glasses for the correction of low to moderate farsightedness
Placebo Comparator: Control
Spectacles with placebo lenses
Device: Glasses with placebo lens



Primary Outcome Measures :
  1. Reading ability [ Time Frame: 6 week primary outcome ]
    Reading ability as measured by the Kaufman Test of Educational Achievement (K-TEA).


Secondary Outcome Measures :
  1. Attention [ Time Frame: 6 week primary outcome ]
    Attention as measured by the Cognitive Assessment System.

  2. Symptoms [ Time Frame: 6 week primary outcome ]
    Improvement in symptoms as measured by a standardized questionnaire.

  3. Visual ability [ Time Frame: 6 week primary outcome ]
    Improvement in accommodative and/or vergence function.



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Ages Eligible for Study:   6 Years to 11 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00472212


Locations
United States, Illinois
Illinois College of Optometry/Illinois Eye Institute
Chicago, Illinois, United States, 60616
United States, New York
SUNY College of Optometry/University Optometric Center
New York, New York, United States, 10036
United States, Ohio
The Ohio State University
Columbus, Ohio, United States, 43210
United States, Tennessee
Southern College of Optometry
Memphis, Tennessee, United States, 38104
Sponsors and Collaborators
Ohio State University
American Academy of Optometry
Transitions
Ohio Lions Eye Research Foundation
College of Optometrists in Vision Development
SUNY Research Foundation
Investigators
Principal Investigator: Marjean Kulp, OD, MS Ohio State University

Responsible Party: Marjean Kulp, Professor, Ohio State University
ClinicalTrials.gov Identifier: NCT00472212     History of Changes
Other Study ID Numbers: 2001H0401
First Posted: May 11, 2007    Key Record Dates
Last Update Posted: October 16, 2014
Last Verified: October 2014

Additional relevant MeSH terms:
Hyperopia
Refractive Errors
Eye Diseases
Methamphetamine
Central Nervous System Stimulants
Physiological Effects of Drugs
Sympathomimetics
Autonomic Agents
Peripheral Nervous System Agents
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Adrenergic Agents
Adrenergic Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Dopamine Uptake Inhibitors