Correction of Farsightedness in Children Study (CHICS)

This study has been completed.
Sponsor:
Collaborators:
American Academy of Optometry
Transitions
Ohio Lions Eye Research Foundation
College of Optometrists in Vision Development
SUNY Research Foundation
Information provided by:
Ohio State University
ClinicalTrials.gov Identifier:
NCT00472212
First received: May 9, 2007
Last updated: March 10, 2011
Last verified: March 2011
  Purpose

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 Intervention
Hyperopia
Farsightedness
Device: Glasses for the correction of low to moderate farsightedness
Device: Glasses with placebo lens

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Correction of Hyperopia in Children Study

Resource links provided by NLM:


Further study details as provided by Ohio State University:

Primary Outcome Measures:
  • Reading ability [ Designated as safety issue: No ]
    Reading ability as measured by the Kaufman Test of Educational Achievement (K-TEA).


Secondary Outcome Measures:
  • Attention [ Designated as safety issue: No ]
    Attention as measured by the Cognitive Assessment System.

  • Symptoms [ Designated as safety issue: No ]
    Improvement in symptoms as measured by a standardized questionnaire.

  • Visual ability [ Designated as safety issue: No ]
    Improvement in accommodative and/or vergence function.


Enrollment: 48
Study Start Date: November 2003
Study Completion Date: March 2008
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   6 Years to 11 Years
Genders Eligible for Study:   Both
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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided

Responsible Party: Marjean Kulp, OD, MS, College of Optometry, The Ohio State University
ClinicalTrials.gov Identifier: NCT00472212     History of Changes
Other Study ID Numbers: 2001H0401
Study First Received: May 9, 2007
Last Updated: March 10, 2011
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on September 18, 2014