Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-24 @ 11:45 PM
Ignite Modification Date:
2025-12-24 @ 11:45 PM
NCT ID:
NCT04728451
Brief 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.
Study:
NCT04728451
Study Brief:
Protocol Section:
NCT04728451