NCT00472212

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
58

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Nov 2003

Longer than P75 for not_applicable

Geographic Reach
1 country

4 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2003

Completed
3.5 years until next milestone

First Submitted

Initial submission to the registry

May 9, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 11, 2007

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2008

Completed
14.5 years until next milestone

Results Posted

Study results publicly available

August 29, 2022

Completed
Last Updated

April 18, 2023

Status Verified

March 1, 2023

Enrollment Period

4.3 years

First QC Date

May 9, 2007

Results QC Date

July 1, 2022

Last Update Submit

March 21, 2023

Conditions

HyperopiaFarsightedness

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (2)

  • 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

  • Change in Accommodative Response From Baseline to After 6 Weeks of Assigned Treatment (Hyperopic or Control Correction)

    6 week outcome exam

Study Arms (2)

Spectacles

EXPERIMENTAL

Spectacles with hyperopic lenses

Device: Spectacles

Control

PLACEBO COMPARATOR

Spectacles with placebo lenses

Device: Control

Interventions

SpectaclesDEVICE

Hyperopic spectacle lenses

Spectacles
ControlDEVICE

Plano (no power, control) spectacle lenses

Control

Eligibility Criteria

Age6 Years - 11 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Illinois College of Optometry/Illinois Eye Institute

Chicago, Illinois, 60616, United States

Location

SUNY College of Optometry/University Optometric Center

New York, New York, 10036, United States

Location

The Ohio State University

Columbus, Ohio, 43210, United States

Location

Southern College of Optometry

Memphis, Tennessee, 38104, United States

Location

MeSH Terms

Conditions

Hyperopia

Interventions

Eyeglasses

Condition Hierarchy (Ancestors)

Refractive ErrorsEye Diseases

Intervention Hierarchy (Ancestors)

LensesOptical DevicesEquipment and Supplies

Results Point of Contact

Title
Marjean Kulp
Organization
The Ohio State University College of Optometry
kulp.6@osu.edu
614-688-3336

Study Officials

  • Marjean Kulp, OD

    Ohio State University

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

May 9, 2007

First Posted

May 11, 2007

Study Start

November 1, 2003

Primary Completion

March 1, 2008

Study Completion

March 1, 2008

Last Updated

April 18, 2023

Results First Posted

August 29, 2022

Record last verified: 2023-03

Locations

US(4)