Correction of Farsightedness in Children Study

Not Applicable

Completed

• Conditions: Farsightedness; Hyperopia
• Interventions: Device: Control; Device: Spectacles

• Registration Number: NCT00472212
• Lead Sponsor: Ohio State University

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.

Study Timeline

• Study Start: 2003-11
• Study First Submitted: 2007-05-09
• Study First Submitted QC: 2007-05-10
• Study First Posted: 2007-05-11
• Primary Completion: 2008-03
• Study Completion: 2008-03
• Results First Submitted: 2022-07-01
• Results First Submitted QC: 2022-08-05
• Results First Posted: 2022-08-29
• Status Verified: 2023-03
• Last Update Submitted: 2023-03-21
• Last Update Posted: 2023-04-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 58

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control	Control	Spectacles with placebo lenses
Spectacles	Spectacles	Spectacles with hyperopic lenses

Primary Outcome Measures

Name	Time	Method
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)	6 week outcome exam	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

Name	Time	Method
Change in Cognitive Assessment System (CAS) Attention Scores as Measured From Baseline to After 6 Weeks of Assigned Treatment (Hyperopic or Control Correction)	6 week outcome exam	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)	6 week outcome exam	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.

Trial Locations

Locations (4)

Illinois College of Optometry/Illinois Eye Institute; 🇺🇸 Chicago, Illinois, United States

SUNY College of Optometry/University Optometric Center; 🇺🇸 New York, New York, United States

Southern College of Optometry; 🇺🇸 Memphis, Tennessee, United States

The Ohio State University; 🇺🇸 Columbus, Ohio, United States