Clinical trial NCT04263103: A Training Software (SJ-RS-WL2015) Rehabilitating Intermittent Exotropia Binocular Functions
Official title: 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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Intermittent Exotropia
Keywords: Intermittent Exotropia
Lead sponsor: Guangzhou Shijing Medical Software
Sponsor class: INDUSTRY
Collaborators: name: Zhongshan Ophthalmic Center, Sun Yat-sen University
First posted: 2020-02-10
Enrollment: 92
Sex: ALL
Minimum age (years): 5
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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: All the patients are after eye surgery for intermittent exotropia. All the participants with 20/20 or better visual acuity.

Eligibility criteria: 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

Primary outcomes:
measure: Change from Baseline Stereopsis at 12 months
timeFrame: 12 months
measure: Change from Baseline Fusion at 12 months
timeFrame: 12 months
measure: Change from Baseline Simultaneous Perception at 12 months
timeFrame: 12 months
measure: Change from Baseline Stereopsis at 6 months
timeFrame: 6 months
measure: Change from Baseline Fusion at 6 months
timeFrame: 6 months
measure: Change from Baseline Simultaneous Perception at 6 months
timeFrame: 6 months
measure: Change from Baseline Stereopsis at 3 months
timeFrame: 3 months
measure: Change from Baseline Fusion at 3 months
timeFrame: 3 months
measure: Change from Baseline Simultaneous Perception at 3 months
timeFrame: 3 months
measure: Change from Baseline Stereopsis at 2 months
timeFrame: 2 months
measure: Change from Baseline Fusion at 2 months
timeFrame: 2 months
measure: Change from Baseline Simultaneous Perception at 2 months
timeFrame: 2 months
measure: Change from Baseline Stereopsis at 1 month
timeFrame: 1 month
measure: Change from Baseline Fusion at 1 month
timeFrame: 1 month
measure: Change from Baseline Simultaneous Perception at 1 month
timeFrame: 1 month
Secondary outcomes:
measure: Visual Acuity
timeFrame: one year
measure: Change from Baseline Deviation Degree at 1 year
timeFrame: 1 year
measure: Change from Baseline Refractive Error at 1 year
timeFrame: 1 year
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Guangzhou Shijing Medical Software Co., Ltd.
state: Guangdong
city: Guanzhou
country: China
facility: Zhongshan Ophthalmic center, Sun Yat-sen University
state: Guangdong
Study officials:
References: