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

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04263103
Enrollment
92
Registered
2020-02-10
Start date
2019-12-09
Completion date
2020-12-31
Last updated
2020-02-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Intermittent Exotropia

Keywords

Intermittent Exotropia

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.

Interventions

OTHERSJ-RS-WL2015 visual training program software

It is a software with perceptual learning methods for binocular functions

Sponsors

Zhongshan Ophthalmic Center, Sun Yat-sen University
CollaboratorOTHER
Guangzhou Shijing Medical Software
Lead SponsorINDUSTRY

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
5 Years to 16 Years
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

Design outcomes

Primary

MeasureTime frameDescription
Change from Baseline Simultaneous Perception at 1 month1 monthMeasured with Bagolini striated lens, Worth 4-dot test, and Synoptophore,
Change from Baseline Simultaneous Perception at 2 months2 monthsMeasured with Bagolini striated lens, Worth 4-dot test, and Synoptophore, respectively
Change from Baseline Stereopsis at 1 month1 monthMeasured with Synoptophore and Titmus stereo test, respectively
Change from Baseline Fusion at 1 month1 monthMeasured with Worth 4-dot test and Synoptophore, respectively
Change from Baseline Stereopsis at 12 months12 monthsMeasured with Synoptophore and Titmus stereo test, respectively
Change from Baseline Fusion at 12 months12 monthsMeasured with Worth 4-dot test and Synoptophore, respectively
Change from Baseline Simultaneous Perception at 12 months12 monthsMeasured with Bagolini striated lens, Worth 4-dot test, and Synoptophore, respectively
Change from Baseline Fusion at 3 months3 monthsMeasured with Worth 4-dot test and Synoptophore, respectively
Change from Baseline Stereopsis at 6 months6 monthsMeasured with Synoptophore and Titmus stereo test, respectively
Change from Baseline Fusion at 6 months6 monthsMeasured with Worth 4-dot test and Synoptophore, respectively
Change from Baseline Simultaneous Perception at 6 months6 monthsMeasured with Bagolini striated lens, Worth 4-dot test, and Synoptophore, respectively
Change from Baseline Stereopsis at 3 months3 monthsMeasured with Synoptophore and Titmus stereo test, respectively
Change from Baseline Simultaneous Perception at 3 months3 monthsMeasured with Bagolini striated lens, Worth 4-dot test, and Synoptophore, respectively
Change from Baseline Stereopsis at 2 months2 monthsMeasured with Synoptophore and Titmus stereo test, respectively
Change from Baseline Fusion at 2 months2 monthsMeasured with Worth 4-dot test and Synoptophore, respectively

Secondary

MeasureTime frameDescription
Change from Baseline Deviation Degree at 1 year1 yearby Prism Test
Change from Baseline Refractive Error at 1 year1 yearby Phoropter
Visual Acuityone yearby LogMAR Visual Acuity Chart

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026