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

NCT ID: NCT04263103

Last Updated: 2020-02-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

92 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-12-09

Study Completion Date

2020-12-31

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.

Conditions

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Intermittent Exotropia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Caregivers Investigators Outcome Assessors

Study Groups

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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

Group Type EXPERIMENTAL

SJ-RS-WL2015 visual training program software

Intervention Type OTHER

It is a software with perceptual learning methods for binocular functions

control group

No special treatment, but observation

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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SJ-RS-WL2015 visual training program software

It is a software with perceptual learning methods for binocular functions

Intervention Type OTHER

Other Intervention Names

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SJ-RS-WL2015 visual training program

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
Minimum Eligible Age

5 Years

Maximum Eligible Age

16 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Zhongshan Ophthalmic Center, Sun Yat-sen University

OTHER

Sponsor Role collaborator

Guangzhou Shijing Medical Software

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Guangzhou Shijing Medical Software Co., Ltd.

Guangzhou, Guangdong, China

Site Status

Zhongshan Ophthalmic center, Sun Yat-sen University

Guanzhou, Guangdong, China

Site Status

Countries

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China

Other Identifiers

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GuangzhouShijingMS2020ITE

Identifier Type: -

Identifier Source: org_study_id

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