Farsightedness, Hyperopia
Conditions
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.
Interventions
DEVICESpectacles
Hyperopic spectacle lenses
DEVICEControl
Plano (no power, control) spectacle lenses
Sponsors
American Academy of Optometry
Transitions
Ohio Lions Eye Research Foundation
College of Optometrists in Vision Development
SUNY Research Foundation
Ohio State University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
6 Years to 11 Years
Healthy volunteers
Yes
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Glasses With Hyperopic Lenses Spectacles with hyperopic lenses
Spectacles: Hyperopic spectacle lenses | 31 |
| Control Spectacles with placebo lenses
Control: Plano (no power, control) spectacle lenses | 27 |
| Total | 58 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 6 | 4 |
Baseline characteristics
| Characteristic | Total | Control | Glasses With Hyperopic Lenses |
|---|---|---|---|
| Accommodative Response by monocular estimation method (MEM) | 0.69 diopters STANDARD_DEVIATION 0.43 | 0.67 diopters STANDARD_DEVIATION 0.45 | 0.71 diopters STANDARD_DEVIATION 0.42 |
| Age, Continuous | 7.5 years STANDARD_DEVIATION 1.64 | 7.41 years STANDARD_DEVIATION 1.47 | 7.58 years STANDARD_DEVIATION 1.78 |
| Cognitive Assessment System (CAS) Attention Score | 99.82 units on a scale (standard score) STANDARD_DEVIATION 18.25 | 101.96 units on a scale (standard score) STANDARD_DEVIATION 19.52 | 97.83 units on a scale (standard score) STANDARD_DEVIATION 17.09 |
| Kaufman Test of Educational Achievement (K-TEA) Reading Comprehension Score | 96.09 units on a scale (standard score) STANDARD_DEVIATION 13.34 | 97.07 units on a scale (standard score) STANDARD_DEVIATION 13.38 | 95.17 units on a scale (standard score) STANDARD_DEVIATION 13.47 |
| Race/Ethnicity, Customized African American | 35 Participants | 17 Participants | 18 Participants |
| Race/Ethnicity, Customized Hispanic | 5 Participants | 1 Participants | 4 Participants |
| Race/Ethnicity, Customized White | 17 Participants | 9 Participants | 8 Participants |
| Sex: Female, Male Female | 30 Participants | 13 Participants | 17 Participants |
| Sex: Female, Male Male | 28 Participants | 14 Participants | 14 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 31 | 0 / 27 |
| other Total, other adverse events | 0 / 31 | 0 / 27 |
| serious Total, serious adverse events | 0 / 31 | 0 / 27 |
Outcome results
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)
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
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Glasses With Hyperopic Lenses | 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 score on a scale |
| Control | 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) | 0.088 score on a scale |
Secondary
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.
Time frame: 6 week outcome exam
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Glasses With Hyperopic Lenses | Change in Accommodative Response From Baseline to After 6 Weeks of Assigned Treatment (Hyperopic or Control Correction) | 0.23 Diopters |
| Control | Change in Accommodative Response From Baseline to After 6 Weeks of Assigned Treatment (Hyperopic or Control Correction) | 0.054 Diopters |
Secondary
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.
Time frame: 6 week outcome exam
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Glasses With Hyperopic Lenses | 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 score on a scale |
| Control | Change in Cognitive Assessment System (CAS) Attention Scores as Measured From Baseline to After 6 Weeks of Assigned Treatment (Hyperopic or Control Correction) | 3.46 score on a scale |