Correction of Farsightedness in Children Study - Full Text View

Correction of Farsightedness in Children Study (CHICS)

This study has been completed.

First Received on May 9, 2007. Last Updated on March 10, 2011 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 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:

MedlinePlus related topics: Eye Wear Methamphetamine

Drug Information available for: Methamphetamine hydrochloride Amphetamine Methamphetamine

U.S. FDA Resources

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

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
Amphetamine
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 February 09, 2012