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

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

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).

Study Overview

• Status: Unknown
• Conditions: Intermittent Exotropia
• Intervention / Treatment: Other: SJ-RS-WL2015 visual training program software

Detailed Description

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

• Study Type: Interventional
• Enrollment (Actual): 92
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Guangdong
    • Guangzhou, Guangdong, China, 510000
      • Guangzhou Shijing Medical Software Co., Ltd.
    • Guanzhou, Guangdong, China, 510000
      • Zhongshan Ophthalmic Center, Sun Yat-sen University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 5 years to 16 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Experimental group with SJ-RS-WL2015; 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; It is a software with perceptual learning methods for binocular functions; Other Names: SJ-RS-WL2015 visual training program
No Intervention: control group; No special treatment, but observation

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Guangzhou Shijing Medical Software
• Collaborators: Zhongshan Ophthalmic Center, Sun Yat-sen University

Study record dates

Study Major Dates

• Study Start (Actual): December 9, 2019
• Primary Completion (Anticipated): October 31, 2020
• Study Completion (Anticipated): December 31, 2020

Study Registration Dates

• First Submitted: February 6, 2020
• First Submitted That Met QC Criteria: February 7, 2020
• First Posted (Actual): February 10, 2020

Study Record Updates

• Last Update Posted (Actual): February 10, 2020
• Last Update Submitted That Met QC Criteria: February 7, 2020
• Last Verified: February 1, 2020

More Information

Terms related to this study

• Keywords: Intermittent Exotropia
• Additional Relevant MeSH Terms: Nervous System Diseases; Eye Diseases; Cranial Nerve Diseases; Ocular Motility Disorders; Strabismus; Exotropia
• Other Study ID Numbers: GuangzhouShijingMS2020ITE

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No