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| Name | Class |
|---|---|
| American Academy of Optometry | OTHER |
| Transitions | INDUSTRY |
| Ohio Lions Eye Research Foundation | OTHER |
| College of Optometrists in Vision Development |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Spectacles | Experimental | Spectacles with hyperopic lenses |
|
| Control | Placebo Comparator | Spectacles with placebo lenses |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Spectacles | Device | Hyperopic spectacle lenses |
| |
| Control |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
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:
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| Name | Affiliation | Role |
|---|---|---|
| Marjean Kulp, OD | Ohio State University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Illinois College of Optometry/Illinois Eye Institute | Chicago | Illinois | 60616 | United States | ||
| SUNY College of Optometry/University Optometric Center |
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| ID | Title | Description |
|---|---|---|
| FG000 | Glasses With Hyperopic Lenses | Spectacles with hyperopic lenses Spectacles: Hyperopic spectacle lenses |
| FG001 | Control | Spectacles with placebo lenses Control: Plano (no power, control) spectacle lenses |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Glasses With Hyperopic Lenses | Spectacles with hyperopic lenses Spectacles: Hyperopic spectacle lenses |
| BG001 | Control | Spectacles with placebo lenses Control: Plano (no power, control) spectacle lenses |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Posted | Least Squares Mean | 95% Confidence Interval | score on a scale | 6 week outcome exam |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Glasses With Hyperopic Lenses | Spectacles with hyperopic lenses Spectacles: Hyperopic spectacle lenses |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Marjean Kulp | The Ohio State University College of Optometry | 614-688-3336 | kulp.6@osu.edu |
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| ID | Term |
|---|---|
| D006956 | Hyperopia |
| ID | Term |
|---|---|
| D012030 | Refractive Errors |
| D005128 | Eye Diseases |
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| ID | Term |
|---|---|
| D005139 | Eyeglasses |
| ID | Term |
|---|---|
| D007909 | Lenses |
| D055096 | Optical Devices |
| D004864 | Equipment and Supplies |
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| OTHER |
| SUNY Research Foundation | OTHER |
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| Device |
Plano (no power, control) spectacle lenses |
|
| 6 week outcome exam |
| 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. | 6 week outcome exam |
| New York |
| New York |
| 10036 |
| United States |
| The Ohio State University | Columbus | Ohio | 43210 | United States |
| Southern College of Optometry | Memphis | Tennessee | 38104 | United States |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | One subject with race /ethnicity not reported | Count of Participants | Participants |
|
| Kaufman Test of Educational Achievement (K-TEA) Reading Comprehension Score | Baseline vision and baseline educational testing completed at separate visits. The Kaufman Test of Educational Achievement (K-TEA) was used to measure change in reading skills (decoding and 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. | Test results not available for two subjects. | Mean | Standard Deviation | units on a scale (standard score) |
|
| Cognitive Assessment System (CAS) Attention Score | Baseline vision and baseline educational testing completed at separate visits. The Cognitive Assessment System (CAS) is a well-researched, norm-referenced measure of cognitive ability. Standard scores are normed to a mean of 100 and a standard deviation of 15 for each battery. The CAS attention battery (Expressive Attention, Number Detection, and Receptive Attention) require the participant to selectively attend to a particular stimulus and inhibit attending to competing stimuli. Higher values represent better performance. | Test results not available for 2 subjects. | Mean | Standard Deviation | units on a scale (standard score) |
|
| Accommodative Response by monocular estimation method (MEM) | Accommodative response, Right eye. Baseline vision and educational testing completed on separate dates. This technique is used to measure the accuracy of focusing (accommodative response) while the subject views a near target. Lower (positive) values represent better accuracy of focusing. | Mean | Standard Deviation | diopters |
|
Glasses with placebo lenses
Control: Glasses with plano (no power, control) spectacle lenses
|
|
| 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. | Posted | Least Squares Mean | 95% Confidence Interval | score on a scale | 6 week outcome exam |
|
|
|
| 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. | Posted | Least Squares Mean | 95% Confidence Interval | Diopters | 6 week outcome exam |
|
|
|
| 0 |
| 31 |
| 0 |
| 31 |
| 0 |
| 31 |
| EG001 | Control | Spectacles with placebo lenses Control: Plano (no power, control) spectacle lenses | 0 | 27 | 0 | 27 | 0 | 27 |
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