NCT03998670

Base-in Prism Spectacles for Intermittent Exotropia

Intermittent Exotropia Study 6: A Pilot Randomized Clinical Trial of Base-in Prism Spectacles for Intermittent Exotropia

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 61 (actual)
• Sponsor: Jaeb Center for Health Research · Academic / Other
• Sex: All
• Age: 3 Years – 13 Years
• Healthy volunteers: Not accepted

Summary

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

Conditions

• Exotropia Intermittent

Interventions

Type	Name	Description
DEVICE	Prism Glasses	Spectacles with refractive correction and base-in relieving prism (40% of the greater of the exodeviation by PACT at distance or near) equally divided between the 2 lenses
DEVICE	Non-Prism Glasses	Spectacles with refractive correction (or plano spectacles if no significant refractive error) and no prism

Timeline

• Start date: 2019-09-01
• Primary completion: 2020-07-30
• Completion: 2020-07-30
• First posted: 2019-06-26
• Last updated: 2023-10-04
• Results posted: 2022-10-17

Locations

28 sites across 1 country: United States