N/A N=58 Randomized Quadruple-blind Treatment

Correction of Farsightedness in Children Study

Hyperopia · Farsightedness

Bottom Line

View on ClinicalTrials.gov: NCT00472212 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Aug 2022

Primary outcome: 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) — -2.92; 0.088 score on a scale

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: Spectacles (Device); Control (Device)
Age: Pediatric · 6+ yrs
Sex: All
Sponsor: Ohio State University
Primary completion: Mar 2008

Outcome Measures

Outcome	Result	p-value
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)	-2.92; 0.088	—
SECONDARY Change in Cognitive Assessment System (CAS) Attention Scores as Measured From Baseline to After 6 Weeks of Assigned Treatment (Hyperopic or Control Correction)	9.14; 3.46	—
SECONDARY Change in Accommodative Response From Baseline to After 6 Weeks of Assigned Treatment (Hyperopic or Control Correction)	0.23; 0.054	—

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.

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)

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00472212). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.