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Status unknownNCT04263103Updated Feb 10, 2020

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

An interventional study of SJ-RS-WL2015 visual training program software in Intermittent Exotropia, sponsored by Guangzhou Shijing Medical Software. Status unknown at 2 sites in China. Open to participants aged 5 Years to 16 Years. Per ClinicalTrials.gov, last updated 2020-02-10.

Sponsored by Guangzhou Shijing Medical Software · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Feb 2020), so the status shown — last known as Active, not recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
92
Allocation
Randomized
Ages
5 Years to 16 Years
Sex
All
01

Study 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).

Read the detailed description

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

02

Conditions studied

  • Intermittent Exotropia

Browse trials for

Keywords

  • Intermittent Exotropia
03

Who can participate

Ages eligible
5 Years to 16 Years
Sexes eligible
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

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
04

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Care provider, Investigator, Outcomes assessor)
Enrollment
92 participants (actual)

Study arms

  • 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

  • No intervention
    control group

    No special treatment, but observation

Interventions

  • OtherSJ-RS-WL2015 visual training program software

    It is a software with perceptual learning methods for binocular functions

    Also known as: SJ-RS-WL2015 visual training program

05

What researchers measure

Primary outcomes

  1. Change from Baseline Stereopsis at 12 months

    Measured with Synoptophore and Titmus stereo test, respectively

    Time frame: 12 months

  2. Change from Baseline Fusion at 12 months

    Measured with Worth 4-dot test and Synoptophore, respectively

    Time frame: 12 months

  3. Change from Baseline Simultaneous Perception at 12 months

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

    Time frame: 12 months

  4. Change from Baseline Stereopsis at 6 months

    Measured with Synoptophore and Titmus stereo test, respectively

    Time frame: 6 months

  5. Change from Baseline Fusion at 6 months

    Measured with Worth 4-dot test and Synoptophore, respectively

    Time frame: 6 months

  6. Change from Baseline Simultaneous Perception at 6 months

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

    Time frame: 6 months

  7. Change from Baseline Stereopsis at 3 months

    Measured with Synoptophore and Titmus stereo test, respectively

    Time frame: 3 months

  8. Change from Baseline Fusion at 3 months

    Measured with Worth 4-dot test and Synoptophore, respectively

    Time frame: 3 months

  9. Change from Baseline Simultaneous Perception at 3 months

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

    Time frame: 3 months

  10. Change from Baseline Stereopsis at 2 months

    Measured with Synoptophore and Titmus stereo test, respectively

    Time frame: 2 months

  11. Change from Baseline Fusion at 2 months

    Measured with Worth 4-dot test and Synoptophore, respectively

    Time frame: 2 months

  12. Change from Baseline Simultaneous Perception at 2 months

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

    Time frame: 2 months

  13. Change from Baseline Stereopsis at 1 month

    Measured with Synoptophore and Titmus stereo test, respectively

    Time frame: 1 month

  14. Change from Baseline Fusion at 1 month

    Measured with Worth 4-dot test and Synoptophore, respectively

    Time frame: 1 month

  15. Change from Baseline Simultaneous Perception at 1 month

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

    Time frame: 1 month

Secondary outcomes

  1. Visual Acuity

    by LogMAR Visual Acuity Chart

    Time frame: one year

  2. Change from Baseline Deviation Degree at 1 year

    by Prism Test

    Time frame: 1 year

  3. Change from Baseline Refractive Error at 1 year

    by Phoropter

    Time frame: 1 year

06

Study locations

2 sites
  • Guangzhou Shijing Medical Software Co., Ltd.
    Guangzhou, Guangdong 510000, China
  • Zhongshan Ophthalmic center, Sun Yat-sen University
    Guanzhou, Guangdong 510000, China
07

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT04263103
Lead sponsor
Guangzhou Shijing Medical Software
Collaborators
Zhongshan Ophthalmic Center, Sun Yat-sen University
Responsible party
Sponsor
First posted
Feb 10, 2020
Start date
Dec 9, 2019
Primary completion
Oct 31, 2020 (estimated)
Completion
Dec 31, 2020 (estimated)
Last update
Feb 10, 2020

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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