NCT02807350

Trial of Overminus Spectacle Therapy for Intermittent Exotropia

A Randomized Clinical Trial of Overminus Spectacle Therapy for Intermittent Exotropia

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 386 (actual)
• Sponsor: Jaeb Center for Health Research · Academic / Other
• Sex: All
• Age: 3 Years – 10 Years
• Healthy volunteers: Not accepted

Summary

The main objectives of this randomized trial comparing overminus lens treatment to non-overminus (spectacles without overminus or spectacles with plano lenses) are to determine: * The long-term on-treatment effect of overminus treatment on distance intermittent exotropia (IXT) control score. * The off-treatment effect of overminus treatment on distance IXT control score (following weaning and 3 months off treatment).

Detailed description

The main objectives of this randomized trial comparing overminus lens treatment to non-overminus (spectacles without overminus or spectacles with plano lenses) are to determine: * The long-term on-treatment effect of overminus treatment on distance IXT control score. * The off-treatment effect of overminus treatment on distance IXT control score (following weaning and 3 months off treatment). The recently completed IXT3 pilot study (NCT02223650) addressed the question of whether overminus lens therapy has an initial short-term therapeutic effect for IXT while wearing overminus spectacles. There have been no rigorous studies that address the following important questions related to overminus lens therapy: * Does overminus lens therapy have a long-term therapeutic effect for IXT while wearing overminus spectacles (over many months or years)? * Does overminus lens therapy have a long-term therapeutic effect for IXT when overminus spectacles are discontinued? In November 2019, a protocol amendment discontinued overminus lens treatment and extended the study for an additional 18 months after the 18-month randomized trial has ended. The objective of the extension study is to compare long-term refractive error between subjects originally treated with either overminus spectacles or non-overminus spectacles as part of the 18-month randomized trial; treatment is at investigator discretion.

Conditions

• Intermittent Exotropia

Interventions

Type	Name	Description
DEVICE	Overminus treatment	spectacles with full cycloplegic refraction plus 2.50 D overminus added to the sphere
DEVICE	Non-overminus treatment	spectacles with full cycloplegic refraction without overminus

Timeline

• Start date: 2017-01-16
• Primary completion: 2020-11-30
• Completion: 2022-02-15
• First posted: 2016-06-21
• Last updated: 2022-06-03
• Results posted: 2022-06-03

Locations

61 sites across 2 countries: United States, Canada