Correction of Hyperopia in Children Study (CHICS)

This study is currently recruiting participants.

Verified by Ohio State University, July 2008

First Received: May 9, 2007 Last Updated: July 1, 2008 History of Changes

Sponsor:	Ohio State University
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

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

Study Type:	Interventional
Study Design:	Randomized, Double-Blind, Placebo Control, Parallel Assignment

Resource links provided by NLM:

MedlinePlus related topics: Eye Wear

U.S. FDA Resources

Further study details as provided by Ohio State University:

Estimated Enrollment:

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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00472212

Contacts

Contact: Marjean Kulp, OD, MS

614-688-3336

kulp.6@osu.edu

Locations

United States, Illinois
Illinois College of Optometry/Illinois Eye Institute	Recruiting
Chicago, Illinois, United States, 60616
Contact: Wendy Haaland, OD 312-949-7199 WHaaland@ico.edu
Contact: Janice Winters (312) 949-7307
Principal Investigator: Wendy Haaland, OD
Principal Investigator: Janice Winters, OD
United States, New York
SUNY College of Optometry/University Optometric Center	Recruiting
New York, New York, United States, 10036
Contact: Ida Chung, OD 212-938-4140 ichung@sunyopt.edu
Principal Investigator: Ida Chung, OD
United States, Ohio
The Ohio State University	Recruiting
Columbus, Ohio, United States, 43210
Contact: Marjean T Kulp, OD, MS 614-688-3336 kulp.6@osu.edu
Principal Investigator: Marjean Kulp, OD, MS
United States, Tennessee
Southern College of Optometry	Recruiting
Memphis, Tennessee, United States, 38104
Contact: Erin Nosel, OD 901-722-3341 enosel@sco.edu
Contact: Janette Dumas, OD 901 722 3369 jdumas@sco.edu
Principal Investigator: Erin Nosel, OD
Sub-Investigator: Janette Dumas, OD

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

Additional Information:

Related Info This link exits the ClinicalTrials.gov site

No publications provided

Study ID Numbers:	2001H0401
Study First Received:	May 9, 2007
Last Updated:	July 1, 2008
ClinicalTrials.gov Identifier:	NCT00472212 History of Changes
Health Authority:	United States: Institutional Review Board

Additional relevant MeSH terms:

Hyperopia
Eye Diseases
Refractive Errors

ClinicalTrials.gov processed this record on February 08, 2010