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Recruiting NCT07272005

Improving Control of Intermittent Exotropia

No phase Interventional Intermittent Exotropia

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: dichoptic videos, standard videos.
Who it may be relevant to
Registry conditions: Intermittent Exotropia. Basic parameters: 4 years — 10 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Overview

To determine whether use of dichoptic movies for 8 weeks may be helpful in improving control alignment in children with intermittent exotropia (IXT), thus allowing IXT to be managed non-surgically

Detailed description

Intermittent exotropia (IXT) is the most common form of strabismus, characterized by an outward deviation of the eyes that is primarily manifest during distance fixation and can intermittently be controlled by fusional mechanisms. Less than 30% of children have good long-term outcomes following treatment for spontaneously manifest IXT with current non-surgical treatments (prism therapy, over-minus lenses, or vision therapy). The limited efficacy of current non-surgical treatments for IXT is thought to arise from underlying sensory deficits, particularly interocular suppression, which compromises binocular function. This underscores the need for sensory-directed interventions aimed at reducing suppression and thereby enhancing the potential for stable binocular outcomes.

In this study, children will be randomized to watch engaging videos streamed at home that are either dichoptic or standard (control) format. The aim is to determine whether the dichoptic format will decrease suppression and improve control of eye alignment . In previous research, use of dichoptic games and movies by children with amblyopia has shown to reduce suppression.

Interventions

  • Other dichoptic videos
    custom designed dichoptic videos
  • Other standard videos
    standard videos

Primary outcome measures

  • Improvement in control of intermittent exotropia [Time frame: 8 weeks]
Secondary outcome measures (7)
  • Improvement in control of intermittent exotropia [Time frame: 4 weeks]
  • Improvement in control of intermittent exotropia [Time frame: 12 weeks off-treatment]
  • Change in distance stereoacuity [Time frame: 4 weeks]
  • Change in distance stereoacuity [Time frame: 8 weeks]
  • Change in distance stereoacuity [Time frame: 12 weeks off-treatment]
  • Change in quality of life [Time frame: 8 weeks]
  • Change in quality of life [Time frame: 12 weeks off-treatment]

Eligibility criteria

Inclusion criteria

  • Diagnosis of IXT or XT at Distance \& IXT or XP at near (Basic or Pseudo Divergence Excess subtype of IXT)
  • No surgery planned for 6 months

Exclusion criteria

  • Prior eye muscle surgery
  • Prior binocular treatment or vision therapy
  • Amblyopia
  • Neurological conditions, seizure disorders, vestibular abnormalities, or frequent headache
  • Other eye conditions (refractive error OK)

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Triple blind
Primary purpose
Treatment

Study locations

United States · 1 center
  • Retina Foundation of the Southwest — Dallas

Identifiers

NCT: NCT07272005 · 03 IXT2 2026

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗