The purpose of this study is to compare developmental outcome for young children (12 to 35 months of age) with astigmatism meeting American Academy of Ophthalmology spectacle prescribing guidelines and who are prescribed and provided spectacles for either Full-Time wear (encouraged and reinforced) or Ad Lib wear (wear dependent on child acceptance).
The benefits and drawbacks of spectacle treatment for bilateral astigmatism in young children are not known. The SPEC study compares outcomes for young children (12 to \< 35 months of age) with astigmatism meeting spectacle prescribing recommendations and randomized to either Full-Time spectacle wear (encouraged and reinforced) or Ad Lib spectacle wear (only as accepted by the child). The primary outcome analysis compares cognitive development at 38-42 months in children randomized to the Full-Time and Ad Lib groups. Secondary analyses compare Language, Motor, Social-Emotional, and Adaptive Behavior developmental outcomes and visual acuity outcome for children randomized to the Full-Time and Ad Lib groups.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
88
Parents of children in the full-time group are provided with encouragement, support, and counseling throughout the study in order to maximize their child's spectacle wear.
Children prescribed and provided spectacles with full correction of their refractive error, with the exception of prescriptions with ≥ +1.50D sphere (plus cylinder notation) in the least hyperopic eye, which will be symmetrically reduced by 1.00D
The University of Arizona
Tucson, Arizona, United States
Cognitive Development
Cognitive Scale Composite Score on the "Bayley Scales of Infant and Toddler Development, 3rd Edition". Tester is masked to the child's randomized group. Scores (continuous scale) are based on published age norms (mean =100, standard deviation = 15) and range from 40-160 with higher scores indicating better outcomes. A difference of ≥10 points between randomized groups will be considered clinically meaningful.
Time frame: Measured at the Developmental and Visual Assessment Visit (when the child is age 1155-1275 days)
Language Development
Language Scale Composite Score on the "Bayley Scales of Infant and Toddler Development, 3rd Edition". Tester is masked to the child's randomized group. Scores (continuous scale) are based on published age norms (mean =100, standard deviation = 15) and range from 40-160 with higher scores indicating better outcomes. A difference of ≥10 points between randomized groups will be considered clinically meaningful.
Time frame: Measured at the Developmental and Visual Assessment Visit (when the child is age 1155-1275 days)
Motor Development
Motor Scale Composite Score on the "Bayley Scales of Infant and Toddler Development, 3rd Edition". Tester is masked to the child's randomized group. Scores (continuous scale) are based on published age norms (mean =100, standard deviation = 15) and range from 40-160 with higher scores indicating better outcomes. A difference of ≥10 points between randomized groups will be considered clinically meaningful.
Time frame: Measured at the Developmental and Visual Assessment Visit (when the child is age 1155-1275 days)
Social-Emotional Development
Social-Emotional Scale Composite Score on the "Bayley Scales of Infant and Toddler Development, 3rd Edition". Tester is masked to the child's randomized group. Scores (continuous scale) are based on published age norms (mean =100, standard deviation = 15) and range from 40-160 with higher scores indicating better outcomes. A difference of ≥10 points between randomized groups will be considered clinically meaningful.
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Time frame: Measured at the Developmental and Visual Assessment Visit (when the child is age 1155-1275 days)
Adaptive Behavior
Adaptive Behavior Scale Composite Score on the "Bayley Scales of Infant and Toddler Development, 3rd Edition". Tester is masked to the child's randomized group. Scores (continuous scale) are based on published age norms (mean =100, standard deviation = 15) and range from 40-160 with higher scores indicating better outcomes. A difference of ≥10 points between randomized groups will be considered clinically meaningful.
Time frame: Measured at the Developmental and Visual Assessment Visit (when the child is age 1155-1275 days)
Visual Acuity
Binocular visual acuity tested using the Amblyopia Treatment Study HOTV Protocol. Child wears most recent prescription for testing (or no spectacles, if discontinued by study doctor). Tester is masked to the child's randomized group. Acuity is recorded and analyzed as log MAR values (continuous scale). A difference of 0.10 log MAR between randomized groups will be considered clinically meaningful.
Time frame: Measured at the Developmental and Visual Assessment Visit (when the child is age 1155-1275 days)