Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Correction of Farsightedness in Children Study (CHICS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00472212
Recruitment Status : Completed
First Posted : May 11, 2007
Last Update Posted : August 21, 2018
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:
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.

Condition or disease Intervention/treatment Phase
Hyperopia Farsightedness Device: Spectacles Device: Control Not Applicable

Detailed 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.

Layout table for study information
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

Arm Intervention/treatment
Experimental: Spectacles
Spectacles with hyperopic lenses
Device: Spectacles
Hyperopic spectacle lenses

Placebo Comparator: Control
Spectacles with placebo lenses
Device: Control
Plano (no power, control) spectacle lenses




Primary Outcome Measures :
  1. Change in Kaufman Test of Educational Achievement (K-TEA) reading comprehension score as measured after 6 weeks of assigned treatment (hyperopic or control correction) [ Time Frame: 6 week outcome exam ]
    Individually administered battery that provides in-depth assessment of key academic skills


Secondary Outcome Measures :
  1. Change in Cognitive Assessment System (CAS) Attention scores as measured 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.

  2. Change in accommodative response after 6 weeks of assigned treatment (hyperopic or control correction) [ Time Frame: 6 week outcome exam ]
    Accommodative response by monocular estimation method (MEM)



Information from the National Library of Medicine

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, Learn About Clinical Studies.


Layout table for eligibility information
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
Layout table for location information
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
Layout table for investigator information
Principal Investigator: Marjean Kulp, OD, MS Ohio State University
Layout table for additonal information
Responsible Party: Marjean Kulp, Professor, Ohio State University
ClinicalTrials.gov Identifier: NCT00472212    
Other Study ID Numbers: 2001H0401
First Posted: May 11, 2007    Key Record Dates
Last Update Posted: August 21, 2018
Last Verified: August 2018
Additional relevant MeSH terms:
Layout table for MeSH terms
Hyperopia
Refractive Errors
Eye Diseases