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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
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1: Dichoptic Videos | Experimental | dichoptic videos streamed at home 1 hour per day, 5 days per week |
|
| Group 2: Standard Videos | Sham Comparator | standard videos streamed at home 1 hour per day, 5 days per week |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| dichoptic videos | Other | custom designed dichoptic videos |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Improvement in control of intermittent exotropia | change percent time alignment is present at 8 weeks vs at baseline | 8 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Improvement in control of intermittent exotropia | change percent time alignment is present at 4 weeks vs at baseline | 4 weeks |
| Improvement in control of intermittent exotropia | change percent time alignment is present at 12 weeks off-treatment weeks vs at baseline |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Eileen Birch, PhD | Contact | 2143633911 | ebirch@retinafoundation.org | |
| Reed Jost, MS | Contact | 2143633911 | reedjost@retinafoundation.org |
| Name | Affiliation | Role |
|---|---|---|
| Eileen E Birch | Retina Foundation of the Southwest | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Retina Foundation of the Southwest | Recruiting | Dallas | Texas | 75231 | United States |
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| standard videos |
| Other |
standard videos |
|
| 12 weeks off-treatment |
| Change in distance stereoacuity | change in Distance Randot test score at 4 weeks vs at baseline | 4 weeks |
| Change in distance stereoacuity | change in Distance Randot test score at 8 weeks vs at baseline | 8 weeks |
| Change in distance stereoacuity | change in Distance Randot test score at 12 weeks off-treatment vs at baseline | 12 weeks off-treatment |
| Change in quality of life | Change in IXTQ questionnaire (Rasch-scored on a 0-100 scale) at 8 weeks vs at baseline | 8 weeks |
| Change in quality of life | Change in IXTQ questionnaire (Rasch-scored on a 0-100 scale) ay 12 weeks off-treatment vs at baseline | 12 weeks off-treatment |