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Correction of Farsightedness in Children Study (CHICS)

Primary Purpose

Hyperopia, Farsightedness

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Spectacles
Control
Sponsored by
Ohio State University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hyperopia

Eligibility Criteria

6 Years - 11 Years (Child)All SexesAccepts Healthy Volunteers

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)

Sites / Locations

  • Illinois College of Optometry/Illinois Eye Institute
  • SUNY College of Optometry/University Optometric Center
  • The Ohio State University
  • Southern College of Optometry

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Spectacles

Control

Arm Description

Spectacles with hyperopic lenses

Spectacles with placebo lenses

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.

Full Information

First Posted
May 9, 2007
Last Updated
March 21, 2023
Sponsor
Ohio State University
Collaborators
American Academy of Optometry, Transitions, Ohio Lions Eye Research Foundation, College of Optometrists in Vision Development, SUNY Research Foundation
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1. Study Identification

Unique Protocol Identification Number
NCT00472212
Brief Title
Correction of Farsightedness in Children Study
Acronym
CHICS
Official Title
Correction of Hyperopia in Children Study
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Completed
Study Start Date
November 2003 (undefined)
Primary Completion Date
March 2008 (Actual)
Study Completion Date
March 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ohio State University
Collaborators
American Academy of Optometry, Transitions, Ohio Lions Eye Research Foundation, College of Optometrists in Vision Development, SUNY Research Foundation

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hyperopia, Farsightedness

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
58 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Spectacles
Arm Type
Experimental
Arm Description
Spectacles with hyperopic lenses
Arm Title
Control
Arm Type
Placebo Comparator
Arm Description
Spectacles with placebo lenses
Intervention Type
Device
Intervention Name(s)
Spectacles
Intervention Description
Hyperopic spectacle lenses
Intervention Type
Device
Intervention Name(s)
Control
Intervention Description
Plano (no power, control) spectacle lenses
Primary Outcome Measure Information:
Title
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)
Description
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.
Time Frame
6 week outcome exam
Secondary Outcome Measure Information:
Title
Change in Cognitive Assessment System (CAS) Attention Scores as Measured From Baseline to After 6 Weeks of Assigned Treatment (Hyperopic or Control Correction)
Description
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.
Time Frame
6 week outcome exam
Title
Change in Accommodative Response From Baseline to After 6 Weeks of Assigned Treatment (Hyperopic or Control Correction)
Description
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.
Time Frame
6 week outcome exam

10. Eligibility

Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
11 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marjean Kulp, OD
Organizational Affiliation
Ohio State University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Illinois College of Optometry/Illinois Eye Institute
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60616
Country
United States
Facility Name
SUNY College of Optometry/University Optometric Center
City
New York
State/Province
New York
ZIP/Postal Code
10036
Country
United States
Facility Name
The Ohio State University
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43210
Country
United States
Facility Name
Southern College of Optometry
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38104
Country
United States

12. IPD Sharing Statement

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Correction of Farsightedness in Children Study

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