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

Sponsor
Guangzhou Shijing Medical Software (Industry)
Overall Status
Unknown status
CT.gov ID
NCT04263103
Collaborator
Zhongshan Ophthalmic Center, Sun Yat-sen University (Other)
92
Enrollment
2
Locations
2
Arms
12.7
Anticipated Duration (Months)
46
Patients Per Site
3.6
Patients Per Site Per Month

Study Details

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).

Condition or Disease Intervention/Treatment Phase
  • Other: SJ-RS-WL2015 visual training program software
 N/A

Detailed Description

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

Study Design

Study Type:
Interventional
Actual Enrollment :
92 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Triple (Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
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
Actual Study Start Date :
Dec 9, 2019
Anticipated Primary Completion Date :
Oct 31, 2020
Anticipated Study Completion Date :
Dec 31, 2020

Arms and Interventions

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

    Outcome Measures

    Primary Outcome Measures

    1. Change from Baseline Stereopsis at 12 months [12 months]

      Measured with Synoptophore and Titmus stereo test, respectively

    2. Change from Baseline Fusion at 12 months [12 months]

      Measured with Worth 4-dot test and Synoptophore, respectively

    3. Change from Baseline Simultaneous Perception at 12 months [12 months]

      Measured with Bagolini striated lens, Worth 4-dot test, and Synoptophore, respectively

    4. Change from Baseline Stereopsis at 6 months [6 months]

      Measured with Synoptophore and Titmus stereo test, respectively

    5. Change from Baseline Fusion at 6 months [6 months]

      Measured with Worth 4-dot test and Synoptophore, respectively

    6. Change from Baseline Simultaneous Perception at 6 months [6 months]

      Measured with Bagolini striated lens, Worth 4-dot test, and Synoptophore, respectively

    7. Change from Baseline Stereopsis at 3 months [3 months]

      Measured with Synoptophore and Titmus stereo test, respectively

    8. Change from Baseline Fusion at 3 months [3 months]

      Measured with Worth 4-dot test and Synoptophore, respectively

    9. Change from Baseline Simultaneous Perception at 3 months [3 months]

      Measured with Bagolini striated lens, Worth 4-dot test, and Synoptophore, respectively

    10. Change from Baseline Stereopsis at 2 months [2 months]

      Measured with Synoptophore and Titmus stereo test, respectively

    11. Change from Baseline Fusion at 2 months [2 months]

      Measured with Worth 4-dot test and Synoptophore, respectively

    12. Change from Baseline Simultaneous Perception at 2 months [2 months]

      Measured with Bagolini striated lens, Worth 4-dot test, and Synoptophore, respectively

    13. Change from Baseline Stereopsis at 1 month [1 month]

      Measured with Synoptophore and Titmus stereo test, respectively

    14. Change from Baseline Fusion at 1 month [1 month]

      Measured with Worth 4-dot test and Synoptophore, respectively

    15. Change from Baseline Simultaneous Perception at 1 month [1 month]

      Measured with Bagolini striated lens, Worth 4-dot test, and Synoptophore,

    Secondary Outcome Measures

    1. Visual Acuity [one year]

      by LogMAR Visual Acuity Chart

    2. Change from Baseline Deviation Degree at 1 year [1 year]

      by Prism Test

    3. Change from Baseline Refractive Error at 1 year [1 year]

      by Phoropter

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    5 Years to 16 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Guangzhou Shijing Medical Software Co., Ltd. Guangzhou Guangdong China 510000
    2 Zhongshan Ophthalmic center, Sun Yat-sen University Guanzhou Guangdong China 510000

    Sponsors and Collaborators

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

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Guangzhou Shijing Medical Software
    ClinicalTrials.gov Identifier:
    NCT04263103
    Other Study ID Numbers:
    • GuangzhouShijingMS2020ITE
    First Posted:
    Feb 10, 2020
    Last Update Posted:
    Feb 10, 2020
    Last Verified:
    Feb 1, 2020
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Guangzhou Shijing Medical Software
    Intermittent Exotropia
    Additional relevant MeSH terms:
    Exotropia

    Study Results

    No Results Posted as of Feb 10, 2020