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

Intermittent Exotropia Clinical Trial

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04263103
• Other study ID #: GuangzhouShijingMS2020ITE
• Status: Active, not recruiting
• Phase: N/A
• Start date: December 9, 2019
• Est. completion date: December 31, 2020

Study information

• Verified date: February 2020
• Source: Guangzhou Shijing Medical Software
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Description:

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

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 92
• Est. completion date: December 31, 2020
• Est. primary completion date: October 31, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 5 Years to 16 Years

Eligibility

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

Related Conditions & MeSH terms

• Exotropia
• Intermittent Exotropia

Intervention

Other:
• SJ-RS-WL2015 visual training program software
It is a software with perceptual learning methods for binocular functions

Locations

Country	Name	City	State
China	Guangzhou Shijing Medical Software Co., Ltd.	Guangzhou	Guangdong
China	Zhongshan Ophthalmic center, Sun Yat-sen University	Guanzhou	Guangdong

Sponsors (2)

Lead Sponsor	Collaborator
Guangzhou Shijing Medical Software	Zhongshan Ophthalmic Center, Sun Yat-sen University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from Baseline Stereopsis at 12 months	Measured with Synoptophore and Titmus stereo test, respectively	12 months
Primary	Change from Baseline Fusion at 12 months	Measured with Worth 4-dot test and Synoptophore, respectively	12 months
Primary	Change from Baseline Simultaneous Perception at 12 months	Measured with Bagolini striated lens, Worth 4-dot test, and Synoptophore, respectively	12 months
Primary	Change from Baseline Stereopsis at 6 months	Measured with Synoptophore and Titmus stereo test, respectively	6 months
Primary	Change from Baseline Fusion at 6 months	Measured with Worth 4-dot test and Synoptophore, respectively	6 months
Primary	Change from Baseline Simultaneous Perception at 6 months	Measured with Bagolini striated lens, Worth 4-dot test, and Synoptophore, respectively	6 months
Primary	Change from Baseline Stereopsis at 3 months	Measured with Synoptophore and Titmus stereo test, respectively	3 months
Primary	Change from Baseline Fusion at 3 months	Measured with Worth 4-dot test and Synoptophore, respectively	3 months
Primary	Change from Baseline Simultaneous Perception at 3 months	Measured with Bagolini striated lens, Worth 4-dot test, and Synoptophore, respectively	3 months
Primary	Change from Baseline Stereopsis at 2 months	Measured with Synoptophore and Titmus stereo test, respectively	2 months
Primary	Change from Baseline Fusion at 2 months	Measured with Worth 4-dot test and Synoptophore, respectively	2 months
Primary	Change from Baseline Simultaneous Perception at 2 months	Measured with Bagolini striated lens, Worth 4-dot test, and Synoptophore, respectively	2 months
Primary	Change from Baseline Stereopsis at 1 month	Measured with Synoptophore and Titmus stereo test, respectively	1 month
Primary	Change from Baseline Fusion at 1 month	Measured with Worth 4-dot test and Synoptophore, respectively	1 month
Primary	Change from Baseline Simultaneous Perception at 1 month	Measured with Bagolini striated lens, Worth 4-dot test, and Synoptophore,	1 month
Secondary	Visual Acuity	by LogMAR Visual Acuity Chart	one year
Secondary	Change from Baseline Deviation Degree at 1 year	by Prism Test	1 year
Secondary	Change from Baseline Refractive Error at 1 year	by Phoropter	1 year