Protocol: A Pilot Randomized Clinical Trial of Base-in Prism Spectacles for Intermittent Exotropia
Status: Closed
Start Date: 08/27/2019
End Date: 07/30/2020
Clinical Trial ID: NCT03998670
Public Dataset:  

 



IXT6 – A Pilot Randomized Clinical Trial of Base-In Prism Spectacles for Intermittent Exotropia

 

Protocol

Primary Objective:

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 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

 


 



Back