NCT04728451

Spectacle Prescribing in Early Childhood

Spectacle Prescribing in Early Childhood (SPEC)

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 88 (estimated)
• Sponsor: University of Arizona · Academic / Other
• Sex: All
• Age: 12 Months – 35 Months
• Healthy volunteers: Accepted

Summary

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).

Detailed description

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.

Conditions

• Astigmatism Bilateral
• Eyeglasses

Interventions

Type	Name	Description
BEHAVIORAL	Spectacle wear support	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.
DEVICE	Spectacles	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

Timeline

• Start date: 2021-03-25
• Primary completion: 2027-02-01
• Completion: 2027-02-01
• First posted: 2021-01-28
• Last updated: 2024-12-19

Locations

1 site across 1 country: United States