Retina Foundation of the Southwest
Dallas, Texas, 75231, United States
Location status: Recruiting
NCT Number: NCT07272005
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
Interested in participating?
Request Info4 year–10 year
All sexes
Interventional
Not applicable
Dallas, Texas, 75231, United States
Location status: Recruiting
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
custom designed dichoptic videos
standard videos
Time frame: 8 weeks
change percent time alignment is present at 8 weeks vs at baseline
Time frame: 4 weeks
change percent time alignment is present at 4 weeks vs at baseline
Time frame: 12 weeks off-treatment
change percent time alignment is present at 12 weeks off-treatment weeks vs at baseline
Time frame: 4 weeks
change in Distance Randot test score at 4 weeks vs at baseline
Time frame: 8 weeks
change in Distance Randot test score at 8 weeks vs at baseline
Time frame: 12 weeks off-treatment
change in Distance Randot test score at 12 weeks off-treatment vs at baseline
Time frame: 8 weeks
Change in IXTQ questionnaire (Rasch-scored on a 0-100 scale) at 8 weeks vs at baseline
Time frame: 12 weeks off-treatment
Change in IXTQ questionnaire (Rasch-scored on a 0-100 scale) ay 12 weeks off-treatment vs at baseline
Contact information is provided by the study sponsor or research team.
Eileen Birch, PhD
CONTACT
Reed Jost, MS
CONTACT
Retina Foundation of the Southwest
Other
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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