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

February 7, 2020 updated by: Guangzhou Shijing Medical Software

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

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

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

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
92

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

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

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change from Baseline Stereopsis at 12 months
Time Frame: 12 months
Measured with Synoptophore and Titmus stereo test, respectively
12 months
Change from Baseline Fusion at 12 months
Time Frame: 12 months
Measured with Worth 4-dot test and Synoptophore, respectively
12 months
Change from Baseline Simultaneous Perception at 12 months
Time Frame: 12 months
Measured with Bagolini striated lens, Worth 4-dot test, and Synoptophore, respectively
12 months
Change from Baseline Stereopsis at 6 months
Time Frame: 6 months
Measured with Synoptophore and Titmus stereo test, respectively
6 months
Change from Baseline Fusion at 6 months
Time Frame: 6 months
Measured with Worth 4-dot test and Synoptophore, respectively
6 months
Change from Baseline Simultaneous Perception at 6 months
Time Frame: 6 months
Measured with Bagolini striated lens, Worth 4-dot test, and Synoptophore, respectively
6 months
Change from Baseline Stereopsis at 3 months
Time Frame: 3 months
Measured with Synoptophore and Titmus stereo test, respectively
3 months
Change from Baseline Fusion at 3 months
Time Frame: 3 months
Measured with Worth 4-dot test and Synoptophore, respectively
3 months
Change from Baseline Simultaneous Perception at 3 months
Time Frame: 3 months
Measured with Bagolini striated lens, Worth 4-dot test, and Synoptophore, respectively
3 months
Change from Baseline Stereopsis at 2 months
Time Frame: 2 months
Measured with Synoptophore and Titmus stereo test, respectively
2 months
Change from Baseline Fusion at 2 months
Time Frame: 2 months
Measured with Worth 4-dot test and Synoptophore, respectively
2 months
Change from Baseline Simultaneous Perception at 2 months
Time Frame: 2 months
Measured with Bagolini striated lens, Worth 4-dot test, and Synoptophore, respectively
2 months
Change from Baseline Stereopsis at 1 month
Time Frame: 1 month
Measured with Synoptophore and Titmus stereo test, respectively
1 month
Change from Baseline Fusion at 1 month
Time Frame: 1 month
Measured with Worth 4-dot test and Synoptophore, respectively
1 month
Change from Baseline Simultaneous Perception at 1 month
Time Frame: 1 month
Measured with Bagolini striated lens, Worth 4-dot test, and Synoptophore,
1 month

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Visual Acuity
Time Frame: one year
by LogMAR Visual Acuity Chart
one year
Change from Baseline Deviation Degree at 1 year
Time Frame: 1 year
by Prism Test
1 year
Change from Baseline Refractive Error at 1 year
Time Frame: 1 year
by Phoropter
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Guangzhou Shijing Medical Software

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Zhongshan Ophthalmic Center, Sun Yat-sen University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 9, 2019

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 31, 2020

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 6, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 7, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 10, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 10, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 7, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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