Spectacle Prescribing in Early Childhood — SPEC  

Astigmatism Bilateral Clinical Trial

Official title: Spectacle Prescribing in Early Childhood (SPEC)

Status Recruiting

Clinical Trial 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).

Clinical Trial 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. ;

Related Conditions & MeSH terms

• Astigmatism
• Astigmatism Bilateral
• Eyeglasses

• NCT number: NCT04728451
• Study type: Interventional
• Source: University of Arizona
• Contact: Erin M Harvey, Ph.D.
• Phone: 520-324-3160
• Email: emharvey@arizona.edu
• Status: Recruiting
• Phase: N/A
• Start date: March 26, 2021
• Completion date: February 2027