NCT04263103

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).

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
92

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Dec 2019

Geographic Reach
1 country

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 9, 2019

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

February 6, 2020

Completed
4 days until next milestone

First Posted

Study publicly available on registry

February 10, 2020

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 31, 2020

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2020

Completed
Last Updated

February 10, 2020

Status Verified

February 1, 2020

Enrollment Period

11 months

First QC Date

February 6, 2020

Last Update Submit

February 7, 2020

Conditions

Intermittent Exotropia

Keywords

Intermittent Exotropia

Outcome Measures

Primary Outcomes (15)

  • Change from Baseline Stereopsis at 12 months

    Measured with Synoptophore and Titmus stereo test, respectively

    12 months

  • Change from Baseline Fusion at 12 months

    Measured with Worth 4-dot test and Synoptophore, respectively

    12 months

  • Change from Baseline Simultaneous Perception at 12 months

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

    12 months

  • Change from Baseline Stereopsis at 6 months

    Measured with Synoptophore and Titmus stereo test, respectively

    6 months

  • Change from Baseline Fusion at 6 months

    Measured with Worth 4-dot test and Synoptophore, respectively

    6 months

  • Change from Baseline Simultaneous Perception at 6 months

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

    6 months

  • Change from Baseline Stereopsis at 3 months

    Measured with Synoptophore and Titmus stereo test, respectively

    3 months

  • Change from Baseline Fusion at 3 months

    Measured with Worth 4-dot test and Synoptophore, respectively

    3 months

  • Change from Baseline Simultaneous Perception at 3 months

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

    3 months

  • Change from Baseline Stereopsis at 2 months

    Measured with Synoptophore and Titmus stereo test, respectively

    2 months

  • Change from Baseline Fusion at 2 months

    Measured with Worth 4-dot test and Synoptophore, respectively

    2 months

  • Change from Baseline Simultaneous Perception at 2 months

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

    2 months

  • Change from Baseline Stereopsis at 1 month

    Measured with Synoptophore and Titmus stereo test, respectively

    1 month

  • Change from Baseline Fusion at 1 month

    Measured with Worth 4-dot test and Synoptophore, respectively

    1 month

  • Change from Baseline Simultaneous Perception at 1 month

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

    1 month

Secondary Outcomes (3)

  • Visual Acuity

    one year

  • Change from Baseline Deviation Degree at 1 year

    1 year

  • Change from Baseline Refractive Error at 1 year

    1 year

Study Arms (2)

Experimental group with SJ-RS-WL2015

EXPERIMENTAL

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

control group

NO INTERVENTION

No special treatment, but observation

Interventions

SJ-RS-WL2015 visual training program softwareOTHER

It is a software with perceptual learning methods for binocular functions

Also known as: SJ-RS-WL2015 visual training program
Experimental group with SJ-RS-WL2015

Eligibility Criteria

Age5 Years - 16 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

  • 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
  • +1 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Guangzhou Shijing Medical Software Co., Ltd.

Guangzhou, Guangdong, 510000, China

Location

Zhongshan Ophthalmic center, Sun Yat-sen University

Guanzhou, Guangdong, 510000, China

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 6, 2020

First Posted

February 10, 2020

Study Start

December 9, 2019

Primary Completion

October 31, 2020

Study Completion

December 31, 2020

Last Updated

February 10, 2020

Record last verified: 2020-02

Data Sharing

IPD Sharing
Will not share

Locations

CN(2)