Exotropia Intermittent Clinical Trial
Official title:
Intermittent Exotropia Study 6: A Pilot Randomized Clinical Trial of Base-in Prism Spectacles for Intermittent Exotropia
The objective of this short-term, pilot randomized trial comparing spectacles with relieving prism to spectacles without prism is to determine whether to proceed to a full-scale, longer-term randomized trial. This decision will be based primarily on assessing the initial (8-week) response to prism by comparing treatment groups on the following outcomes: - Mean distance intermittent exotropia (IXT) control score (the mean of 3 control scores) (primary outcome) - The proportion of participants demonstrating a "treatment response," defined as ≥1 point improvement in the mean distance IXT control score without spontaneous exotropia during control testing (secondary outcome) - The proportion of participants reporting adverse effects and good/excellent spectacle wear compliance
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