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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04263103
Recruitment Status : Active, not recruiting
First Posted : February 10, 2020
Last Update Posted : February 10, 2020
Sponsor:
Collaborator:
Zhongshan Ophthalmic Center, Sun Yat-sen University
Information provided by (Responsible Party):
Guangzhou Shijing Medical Software

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
Intermittent Exotropia Other: SJ-RS-WL2015 visual training program software Not Applicable

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

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Study Type : Interventional  (Clinical Trial)
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 : December 9, 2019
Estimated Primary Completion Date : October 31, 2020
Estimated Study Completion Date : December 31, 2020

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 Name: SJ-RS-WL2015 visual training program

No Intervention: control group
No special treatment, but observation



Primary Outcome Measures :
  1. Change from Baseline Stereopsis at 12 months [ Time Frame: 12 months ]
    Measured with Synoptophore and Titmus stereo test, respectively

  2. Change from Baseline Fusion at 12 months [ Time Frame: 12 months ]
    Measured with Worth 4-dot test and Synoptophore, respectively

  3. Change from Baseline Simultaneous Perception at 12 months [ Time Frame: 12 months ]
    Measured with Bagolini striated lens, Worth 4-dot test, and Synoptophore, respectively

  4. Change from Baseline Stereopsis at 6 months [ Time Frame: 6 months ]
    Measured with Synoptophore and Titmus stereo test, respectively

  5. Change from Baseline Fusion at 6 months [ Time Frame: 6 months ]
    Measured with Worth 4-dot test and Synoptophore, respectively

  6. Change from Baseline Simultaneous Perception at 6 months [ Time Frame: 6 months ]
    Measured with Bagolini striated lens, Worth 4-dot test, and Synoptophore, respectively

  7. Change from Baseline Stereopsis at 3 months [ Time Frame: 3 months ]
    Measured with Synoptophore and Titmus stereo test, respectively

  8. Change from Baseline Fusion at 3 months [ Time Frame: 3 months ]
    Measured with Worth 4-dot test and Synoptophore, respectively

  9. Change from Baseline Simultaneous Perception at 3 months [ Time Frame: 3 months ]
    Measured with Bagolini striated lens, Worth 4-dot test, and Synoptophore, respectively

  10. Change from Baseline Stereopsis at 2 months [ Time Frame: 2 months ]
    Measured with Synoptophore and Titmus stereo test, respectively

  11. Change from Baseline Fusion at 2 months [ Time Frame: 2 months ]
    Measured with Worth 4-dot test and Synoptophore, respectively

  12. Change from Baseline Simultaneous Perception at 2 months [ Time Frame: 2 months ]
    Measured with Bagolini striated lens, Worth 4-dot test, and Synoptophore, respectively

  13. Change from Baseline Stereopsis at 1 month [ Time Frame: 1 month ]
    Measured with Synoptophore and Titmus stereo test, respectively

  14. Change from Baseline Fusion at 1 month [ Time Frame: 1 month ]
    Measured with Worth 4-dot test and Synoptophore, respectively

  15. Change from Baseline Simultaneous Perception at 1 month [ Time Frame: 1 month ]
    Measured with Bagolini striated lens, Worth 4-dot test, and Synoptophore,


Secondary Outcome Measures :
  1. Visual Acuity [ Time Frame: one year ]
    by LogMAR Visual Acuity Chart

  2. Change from Baseline Deviation Degree at 1 year [ Time Frame: 1 year ]
    by Prism Test

  3. Change from Baseline Refractive Error at 1 year [ Time Frame: 1 year ]
    by Phoropter



Information from the National Library of Medicine

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04263103


Locations
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China, Guangdong
Guangzhou Shijing Medical Software Co., Ltd.
Guangzhou, Guangdong, China, 510000
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
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Responsible Party: Guangzhou Shijing Medical Software
ClinicalTrials.gov Identifier: NCT04263103    
Other Study ID Numbers: GuangzhouShijingMS2020ITE
First Posted: February 10, 2020    Key Record Dates
Last Update Posted: February 10, 2020
Last Verified: February 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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:
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Exotropia
Strabismus
Ocular Motility Disorders
Cranial Nerve Diseases
Nervous System Diseases
Eye Diseases