Clinical trial NCT00472212: Correction of Farsightedness in Children Study
Official title: Correction of Hyperopia in Children Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hyperopia
Farsightedness
Lead sponsor: Ohio State University
Sponsor class: OTHER
Collaborators: name: American Academy of Optometry
name: Transitions
name: Ohio Lions Eye Research Foundation
name: College of Optometrists in Vision Development
name: SUNY Research Foundation
First posted: 2007-05-11
Enrollment: 58
Sex: ALL
Minimum age (years): 6
Maximum age (years): 11
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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)

Primary outcomes:
measure: 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)
timeFrame: 6 week outcome exam
Secondary outcomes:
measure: Change in Cognitive Assessment System (CAS) Attention Scores as Measured From Baseline to After 6 Weeks of Assigned Treatment (Hyperopic or Control Correction)
timeFrame: 6 week outcome exam
measure: Change in Accommodative Response From Baseline to After 6 Weeks of Assigned Treatment (Hyperopic or Control Correction)
timeFrame: 6 week outcome exam
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Illinois College of Optometry/Illinois Eye Institute
state: Illinois
city: New York
country: United States
facility: SUNY College of Optometry/University Optometric Center
state: New York
city: Columbus
country: United States
facility: The Ohio State University
state: Ohio
city: Memphis
country: United States
facility: Southern College of Optometry
state: Tennessee
Study officials:
affiliation: Ohio State University
name: Marjean Kulp, OD
role: PRINCIPAL_INVESTIGATOR
References: