An interventional study of Spectacle wear support and Spectacles in Astigmatism Bilateral and Eyeglasses, sponsored by University of Arizona. Active, not recruiting at 1 site in United States. Open to participants aged 12 Months to 35 Months, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-12-19.
Sponsored by University of Arizona · Not applicable, Interventional, and Treatment
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.
420 studies on the registry are indexed under Astigmatism; 54 are open to participants now.
This study's planned enrollment of 88 is above the median of 56 across 328 interventional studies indexed under Astigmatism.
Browse Astigmatism studies →University of Arizona is the lead sponsor of 475 studies on the registry; 87 are open to participants now.
Of its 51 completed or terminated interventional studies of FDA-regulated products, 30 (59%) have results posted.
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Exclusion Criteria:
Previously diagnosed manifest strabismus or other ocular abnormalities (per parent report and per medical record):
Previous spectacle wear, amblyopia therapy, or vision therapy (per parent report and per medical record).
Current or previous diagnosis of developmental or neurological conditions (per parent report and per medical record):
History of allergic response to dilating eye drops (per parent report):
Parents are asked to encourage their child to wear the spectacles full-time (all waking hours). A study staff member works closely with families throughout the child's participation to provide support and encouragement and to make suggestions on methods parents can use to maximize spectacle wear.
Behavioral: Spectacle wear support · Device: Spectacles
Parents are asked to encourage their child to wear the spectacles as much as possible for the initial 30 days after dispensing, and thereafter to continue to offer the spectacles to the child but not force the child to wear them if they resist or refuse. Limited support for parents is provided with regard to maximizing spectacle wear.
Device: Spectacles
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
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.
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)
Duration of spectacle wear
Objective measures of duration of spectacle wear (hours/day) assessed objectively with a TheraMon® sensor attached to the child's spectacles. Temperature samples are recorded by the sensor every 15 minutes.
Time frame: From the date of dispensing of the first pair of spectacles at the Spectacle Prescription Verification Visit through the date of the Developmental and Visual Assessment Visit, up to 30 months.
Plan to share: Yes — This study will comply with the NIH Data Sharing Policy and Policy on the Dissemination of NIH-Funded Clinical Trial Information and the Clinical Trials Registration and Results Information Submission rule. De-identified data will be available upon request after publication by contacting the study Principal Investigators.
Supporting information: Study protocol, Informed consent form
Time frame: De-identified data will be available upon request after publication.
Access criteria: De-identified data will be available upon request after publication by contacting the study Principal Investigators.
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This study is active, not recruiting, as verified in Dec 2024. You cannot join it, but the record below documents what was studied.
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