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

Primary Purpose

Intermittent Exotropia

Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
SJ-RS-WL2015 visual training program software
Sponsored by
Guangzhou Shijing Medical Software
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Intermittent Exotropia focused on measuring Intermittent Exotropia

Eligibility Criteria

5 Years - 16 Years (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Guangzhou Shijing Medical Software Co., Ltd.
  • Zhongshan Ophthalmic center, Sun Yat-sen University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Experimental group with SJ-RS-WL2015

control group

Arm Description

Item code: SJ-RS-WL2015, a visual training software program, 15 minutes of one section, twice a day, and for 1 year

No special treatment, but observation

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Visual Acuity
by LogMAR Visual Acuity Chart
Change from Baseline Deviation Degree at 1 year
by Prism Test
Change from Baseline Refractive Error at 1 year
by Phoropter

Full Information

First Posted
February 6, 2020
Last Updated
February 7, 2020
Sponsor
Guangzhou Shijing Medical Software
Collaborators
Zhongshan Ophthalmic Center, Sun Yat-sen University
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1. Study Identification

Unique Protocol Identification Number
NCT04263103
Brief Title
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

2. Study Status

Record Verification Date
February 2020
Overall Recruitment Status
Unknown status
Study Start Date
December 9, 2019 (Actual)
Primary Completion Date
October 31, 2020 (Anticipated)
Study Completion Date
December 31, 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Guangzhou Shijing Medical Software
Collaborators
Zhongshan Ophthalmic Center, Sun Yat-sen University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Intermittent Exotropia
Keywords
Intermittent Exotropia

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Care ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
92 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Experimental group with SJ-RS-WL2015
Arm Type
Experimental
Arm Description
Item code: SJ-RS-WL2015, a visual training software program, 15 minutes of one section, twice a day, and for 1 year
Arm Title
control group
Arm Type
No Intervention
Arm Description
No special treatment, but observation
Intervention Type
Other
Intervention Name(s)
SJ-RS-WL2015 visual training program software
Other Intervention Name(s)
SJ-RS-WL2015 visual training program
Intervention Description
It is a software with perceptual learning methods for binocular functions
Primary Outcome Measure Information:
Title
Change from Baseline Stereopsis at 12 months
Description
Measured with Synoptophore and Titmus stereo test, respectively
Time Frame
12 months
Title
Change from Baseline Fusion at 12 months
Description
Measured with Worth 4-dot test and Synoptophore, respectively
Time Frame
12 months
Title
Change from Baseline Simultaneous Perception at 12 months
Description
Measured with Bagolini striated lens, Worth 4-dot test, and Synoptophore, respectively
Time Frame
12 months
Title
Change from Baseline Stereopsis at 6 months
Description
Measured with Synoptophore and Titmus stereo test, respectively
Time Frame
6 months
Title
Change from Baseline Fusion at 6 months
Description
Measured with Worth 4-dot test and Synoptophore, respectively
Time Frame
6 months
Title
Change from Baseline Simultaneous Perception at 6 months
Description
Measured with Bagolini striated lens, Worth 4-dot test, and Synoptophore, respectively
Time Frame
6 months
Title
Change from Baseline Stereopsis at 3 months
Description
Measured with Synoptophore and Titmus stereo test, respectively
Time Frame
3 months
Title
Change from Baseline Fusion at 3 months
Description
Measured with Worth 4-dot test and Synoptophore, respectively
Time Frame
3 months
Title
Change from Baseline Simultaneous Perception at 3 months
Description
Measured with Bagolini striated lens, Worth 4-dot test, and Synoptophore, respectively
Time Frame
3 months
Title
Change from Baseline Stereopsis at 2 months
Description
Measured with Synoptophore and Titmus stereo test, respectively
Time Frame
2 months
Title
Change from Baseline Fusion at 2 months
Description
Measured with Worth 4-dot test and Synoptophore, respectively
Time Frame
2 months
Title
Change from Baseline Simultaneous Perception at 2 months
Description
Measured with Bagolini striated lens, Worth 4-dot test, and Synoptophore, respectively
Time Frame
2 months
Title
Change from Baseline Stereopsis at 1 month
Description
Measured with Synoptophore and Titmus stereo test, respectively
Time Frame
1 month
Title
Change from Baseline Fusion at 1 month
Description
Measured with Worth 4-dot test and Synoptophore, respectively
Time Frame
1 month
Title
Change from Baseline Simultaneous Perception at 1 month
Description
Measured with Bagolini striated lens, Worth 4-dot test, and Synoptophore,
Time Frame
1 month
Secondary Outcome Measure Information:
Title
Visual Acuity
Description
by LogMAR Visual Acuity Chart
Time Frame
one year
Title
Change from Baseline Deviation Degree at 1 year
Description
by Prism Test
Time Frame
1 year
Title
Change from Baseline Refractive Error at 1 year
Description
by Phoropter
Time Frame
1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
5 Years
Maximum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
Guangzhou Shijing Medical Software Co., Ltd.
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510000
Country
China
Facility Name
Zhongshan Ophthalmic center, Sun Yat-sen University
City
Guanzhou
State/Province
Guangdong
ZIP/Postal Code
510000
Country
China

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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