Trial of Overminus Spectacle Therapy for Intermittent Exotropia — IXT5  

Intermittent Exotropia Clinical Trial

Official title: A Randomized Clinical Trial of Overminus Spectacle Therapy for Intermittent Exotropia

Status Completed

Clinical Trial 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).

Clinical Trial 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. ;

Related Conditions & MeSH terms

• Exotropia
• Intermittent Exotropia

• NCT number: NCT02807350
• Study type: Interventional
• Source: Jaeb Center for Health Research
• Status: Completed
• Phase: N/A
• Start date: January 16, 2017
• Completion date: February 15, 2022