A Training Software (SJ-RS-WL2015) Rehabilitating Intermittent Exotropia Binocular Functions

Study Overview
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Brief Summary
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Evaluating the effect of SJ-RS-WL2015 visual training program in children with intermittent exotropia after eye surgery, including the improvement of simultaneous perception (I binocular function), fusion (II binocular function), stereopsis (III binocular function).

Detailed Description
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All the patients are after eye surgery for intermittent exotropia. All the participants with 20/20 or better visual acuity.

Official Title
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A Phase 4 Randomized, Single-blind Study to Evaluate the Multi-media Training（SJ-RS-WL2015）Software Rehabilitating Ability of Binocular Functions in Hospitalized Adolescent Patients With Intermittent Exotropia After Eye Surgery

Conditions
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Intermittent Exotropia

Intervention / Treatment
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* Other: SJ-RS-WL2015 visual training program software


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Clinical diagnosis of Intermittent Exotropia Must be after eye surgery for Intermittent Exotropia Baseline Deviation Range: Esotropia<=5△ or Exotropia<15△ after Eye Surgery Visual Acuity: >=20/20 Exclusion Criteria: A-V patterns deviations Abnormal oblique or vertical rectus Nystagmus Ophthalmoplegia Anisometropia >2.5D With other eye surgery history Mental disorder Neural disease Tumor Heart disease Hypertension Epilepsy Severe systemic disease With vision therapy history within 4 weeks Implanted electronic device In other researches within 4 weeks

Ages Eligible for Study
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Minimum Age: 5 Years
Maximum Age: 16 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Experimental group with SJ-RS-WL2015<br>Item code: SJ-RS-WL2015, a visual training software program, 15 minutes of one section, twice a day, and for 1 year | Other: SJ-RS-WL2015 visual training program software<br>* It is a software with perceptual learning methods for binocular functions<br>* Other names: SJ-RS-WL2015 visual training program;|
| No Intervention: control group<br>No special treatment, but observation | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from Baseline Stereopsis at 12 months | Measured with Synoptophore and Titmus stereo test, respectively | 12 months | 
| Change from Baseline Fusion at 12 months | Measured with Worth 4-dot test and Synoptophore, respectively | 12 months | 
| Change from Baseline Simultaneous Perception at 12 months | Measured with Bagolini striated lens, Worth 4-dot test, and Synoptophore, respectively | 12 months | 
| Change from Baseline Stereopsis at 6 months | Measured with Synoptophore and Titmus stereo test, respectively | 6 months | 
| Change from Baseline Fusion at 6 months | Measured with Worth 4-dot test and Synoptophore, respectively | 6 months | 
| Change from Baseline Simultaneous Perception at 6 months | Measured with Bagolini striated lens, Worth 4-dot test, and Synoptophore, respectively | 6 months | 
| Change from Baseline Stereopsis at 3 months | Measured with Synoptophore and Titmus stereo test, respectively | 3 months | 
| Change from Baseline Fusion at 3 months | Measured with Worth 4-dot test and Synoptophore, respectively | 3 months | 
| Change from Baseline Simultaneous Perception at 3 months | Measured with Bagolini striated lens, Worth 4-dot test, and Synoptophore, respectively | 3 months | 
| Change from Baseline Stereopsis at 2 months | Measured with Synoptophore and Titmus stereo test, respectively | 2 months | 
| Change from Baseline Fusion at 2 months | Measured with Worth 4-dot test and Synoptophore, respectively | 2 months | 
| Change from Baseline Simultaneous Perception at 2 months | Measured with Bagolini striated lens, Worth 4-dot test, and Synoptophore, respectively | 2 months | 
| Change from Baseline Stereopsis at 1 month | Measured with Synoptophore and Titmus stereo test, respectively | 1 month | 
| Change from Baseline Fusion at 1 month | Measured with Worth 4-dot test and Synoptophore, respectively | 1 month | 
| Change from Baseline Simultaneous Perception at 1 month | Measured with Bagolini striated lens, Worth 4-dot test, and Synoptophore, | 1 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Visual Acuity | by LogMAR Visual Acuity Chart | one year | 
| Change from Baseline Deviation Degree at 1 year | by Prism Test | 1 year | 
| Change from Baseline Refractive Error at 1 year | by Phoropter | 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Intermittent Exotropia