Correction of Farsightedness in Children Study (CHICS)

Correction of Hyperopia in Children Study

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.

Study Overview

• Status: Completed
• Conditions: Hyperopia; Farsightedness
• Intervention / Treatment: Device: Spectacles; Device: Control

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.

• Study Type: Interventional
• Enrollment (Actual): 58
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Illinois
    • Chicago, Illinois, United States, 60616
      • Illinois College of Optometry/Illinois Eye Institute
  • New York
    • New York, New York, United States, 10036
      • SUNY College of Optometry/University Optometric Center
  • Ohio
    • Columbus, Ohio, United States, 43210
      • The Ohio State University
  • Tennessee
    • Memphis, Tennessee, United States, 38104
      • Southern College of Optometry

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 6 years to 11 years (Child)
• Accepts Healthy Volunteers: Yes

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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

Collaborators and Investigators

• Sponsor: Ohio State University
• Collaborators: 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, Ohio State University

Study record dates

Study Major Dates

• Study Start: November 1, 2003
• Primary Completion (Actual): March 1, 2008
• Study Completion (Actual): March 1, 2008

Study Registration Dates

• First Submitted: May 9, 2007
• First Submitted That Met QC Criteria: May 10, 2007
• First Posted (Estimate): May 11, 2007

Study Record Updates

• Last Update Posted (Actual): April 18, 2023
• Last Update Submitted That Met QC Criteria: March 21, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Refractive Errors; Hyperopia
• Other Study ID Numbers: 2001H0401