Correction of Farsightedness in Children Study

Hyperopia Clinical Trial

— CHICS  

Official title:

Correction of Hyperopia in Children Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00472212
• Other study ID #: 2001H0401
• Status: Completed
• Phase: N/A
• Start date: November 2003
• Est. completion date: March 2008

Study information

• Verified date: March 2023
• Source: Ohio State University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 58
• Est. completion date: March 2008
• Est. primary completion date: March 2008
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 6 Years to 11 Years

Eligibility

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)

Related Conditions & MeSH terms

• Farsightedness
• Hyperopia

Intervention

Device:
• Spectacles
Hyperopic spectacle lenses
• Control
Plano (no power, control) spectacle lenses

Locations

Country	Name	City	State
United States	Illinois College of Optometry/Illinois Eye Institute	Chicago	Illinois
United States	The Ohio State University	Columbus	Ohio
United States	Southern College of Optometry	Memphis	Tennessee
United States	SUNY College of Optometry/University Optometric Center	New York	New York

Sponsors (6)

Lead Sponsor	Collaborator
Ohio State University	American Academy of Optometry, College of Optometrists in Vision Development, Ohio Lions Eye Research Foundation, SUNY Research Foundation, Transitions

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Kaufman Test of Educational Achievement (K-TEA) Reading Comprehension Score as Measured From Baseline to After 6 Weeks of Assigned Treatment (Hyperopic or Control Correction)	The Kaufman Test of Educational Achievement (K-TEA) was used to measure change in reading skill (reading comprehension). The K-TEA is a well-established, individually administered, standardized test for assessment of achievement in reading, with a mean standard score of 100 and standard deviation of 15. Higher values represent better performance.	6 week outcome exam
Secondary	Change in Cognitive Assessment System (CAS) Attention Scores as Measured From Baseline to After 6 Weeks of Assigned Treatment (Hyperopic or Control Correction)	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.; A higher score indicates a better outcome.	6 week outcome exam
Secondary	Change in Accommodative Response From Baseline to After 6 Weeks of Assigned Treatment (Hyperopic or Control Correction)	Accommodative response, Right eye. This is a measure the accuracy of focusing (accommodative accuracy or response) while the subject views a near target. Lower (positive) values represent better accuracy of focusing.	6 week outcome exam