Intermittent ExotropiaNCT04263103
A Training Software (SJ-RS-WL2015) Rehabilitating Intermittent Exotropia Binocular Functions
A study testing SJ-RS-WL2015 visual training program software in people with Intermittent Exotropia, run by Guangzhou Shijing Medical Software at 2 sites in China.
Trial 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 more about this study
- Who is it for?
- Ages 5 to 16 years
- Conditions the study is for
- Intermittent Exotropia
- What is being tested?
- SJ-RS-WL2015 visual training program software
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 92 participants
- Where
- 2 sitesChina
- Study dates
- 9 Dec 2019to 31 Dec 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 to 16 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- A-V patterns deviations
- Abnormal oblique or vertical rectus
- Nystagmus
- Ophthalmoplegia
- Anisometropia >2.5D
- With other eye surgery history
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- 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
Trial locations and contacts
2 sites in 1 country.
China2 sites
Guangzhou Shijing Medical Software Co., Ltd.
Guangzhou, Guangdong, 510000
Zhongshan Ophthalmic center, Sun Yat-sen University
Guanzhou, Guangdong, 510000
About this study
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
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.
- Conditions
- Intermittent Exotropia
- Being tested
- SJ-RS-WL2015 visual training program software
- Keywords
- Intermittent Exotropia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SJ-RS-WL2015 visual training program softwareOther
Also called SJ-RS-WL2015 visual training program
It is a software with perceptual learning methods for binocular functions
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Other: SJ-RS-WL2015 visual training program software |
| control group | No intervention | No special treatment, but observation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline Stereopsis at 12 months
Measured with Synoptophore and Titmus stereo test, respectively
Measured: 12 months
Change from Baseline Fusion at 12 months
Measured with Worth 4-dot test and Synoptophore, respectively
Measured: 12 months
Change from Baseline Simultaneous Perception at 12 months
Measured with Bagolini striated lens, Worth 4-dot test, and Synoptophore, respectively
Measured: 12 months
Change from Baseline Stereopsis at 6 months
Measured with Synoptophore and Titmus stereo test, respectively
Measured: 6 months
Change from Baseline Fusion at 6 months
Measured with Worth 4-dot test and Synoptophore, respectively
Measured: 6 months
Change from Baseline Simultaneous Perception at 6 months
Measured with Bagolini striated lens, Worth 4-dot test, and Synoptophore, respectively
Measured: 6 months
Change from Baseline Stereopsis at 3 months
Measured with Synoptophore and Titmus stereo test, respectively
Measured: 3 months
Change from Baseline Fusion at 3 months
Measured with Worth 4-dot test and Synoptophore, respectively
Measured: 3 months
Change from Baseline Simultaneous Perception at 3 months
Measured with Bagolini striated lens, Worth 4-dot test, and Synoptophore, respectively
Measured: 3 months
Change from Baseline Stereopsis at 2 months
Measured with Synoptophore and Titmus stereo test, respectively
Measured: 2 months
Change from Baseline Fusion at 2 months
Measured with Worth 4-dot test and Synoptophore, respectively
Measured: 2 months
Change from Baseline Simultaneous Perception at 2 months
Measured with Bagolini striated lens, Worth 4-dot test, and Synoptophore, respectively
Measured: 2 months
Change from Baseline Stereopsis at 1 month
Measured with Synoptophore and Titmus stereo test, respectively
Measured: 1 month
Change from Baseline Fusion at 1 month
Measured with Worth 4-dot test and Synoptophore, respectively
Measured: 1 month
Change from Baseline Simultaneous Perception at 1 month
Measured with Bagolini striated lens, Worth 4-dot test, and Synoptophore,
Measured: 1 month
Secondary outcomes (3)
Visual Acuity
by LogMAR Visual Acuity Chart
Measured: one year
Change from Baseline Deviation Degree at 1 year
by Prism Test
Measured: 1 year
Change from Baseline Refractive Error at 1 year
by Phoropter
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2020
- Study start9 Dec 2019
- Primary completion31 Oct 2020 (estimated)
- Study completion31 Dec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intermittent ExotropiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Care provider, Investigator, Outcomes assessor
- Enrolment
- 92 participants (actual)
Sponsor and investigators
- Lead sponsor
- Guangzhou Shijing Medical Software
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Zhongshan Ophthalmic Center, Sun Yat-sen University
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04263103
- Sponsor's protocol ID
- GuangzhouShijingMS2020ITE
- Status last verified
- Feb 2020
- First submitted
- 6 Feb 2020
- Last updated
- 10 Feb 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04263103
- Acronym / sponsor ID
- GuangzhouShijingMS2020ITE
- Conditions
- Intermittent Exotropia
- Keywords
- Intermittent Exotropia
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 92 participants (actual)
- Lead sponsor
- Guangzhou Shijing Medical SoftwareIndustry (pharma, biotech, devices)
- Collaborators
- Zhongshan Ophthalmic Center, Sun Yat-sen University
- Study start
- 9 Dec 2019 (actual)
- Primary completion
- 31 Oct 2020 (estimated)
- Study completion
- 31 Dec 2020 (estimated)
- First posted
- 10 Feb 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental group with SJ-RS-WL2015 | Experimental | Other: SJ-RS-WL2015 visual training program softwareItem code: SJ-RS-WL2015, a visual training software program, 15 minutes of one section, twice a day, and for 1 year |
| control group | No intervention | –No special treatment, but observation |
Who may qualify
- Ages
- 5 to 16 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (16 listed)
- A-V patterns deviations
- Abnormal oblique or vertical rectus
- Nystagmus
- Ophthalmoplegia
- Anisometropia >2.5D
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SJ-RS-WL2015 visual training program softwareAlso: SJ-RS-WL2015 visual training programIt is a software with perceptual learning methods for binocular functions | Other | Experimental group with SJ-RS-WL2015 |
Primary outcome
Change from Baseline Stereopsis at 12 months
Time frame: 12 months
Measured with Synoptophore and Titmus stereo test, respectively
Change from Baseline Fusion at 12 months
Time frame: 12 months
Measured with Worth 4-dot test and Synoptophore, respectively
Change from Baseline Simultaneous Perception at 12 months
Time frame: 12 months
Measured with Bagolini striated lens, Worth 4-dot test, and Synoptophore, respectively
Change from Baseline Stereopsis at 6 months
Time frame: 6 months
Measured with Synoptophore and Titmus stereo test, respectively
Change from Baseline Fusion at 6 months
Time frame: 6 months
Measured with Worth 4-dot test and Synoptophore, respectively
Change from Baseline Simultaneous Perception at 6 months
Time frame: 6 months
Measured with Bagolini striated lens, Worth 4-dot test, and Synoptophore, respectively
Change from Baseline Stereopsis at 3 months
Time frame: 3 months
Measured with Synoptophore and Titmus stereo test, respectively
Change from Baseline Fusion at 3 months
Time frame: 3 months
Measured with Worth 4-dot test and Synoptophore, respectively
Change from Baseline Simultaneous Perception at 3 months
Time frame: 3 months
Measured with Bagolini striated lens, Worth 4-dot test, and Synoptophore, respectively
Change from Baseline Stereopsis at 2 months
Time frame: 2 months
Measured with Synoptophore and Titmus stereo test, respectively
Change from Baseline Fusion at 2 months
Time frame: 2 months
Measured with Worth 4-dot test and Synoptophore, respectively
Change from Baseline Simultaneous Perception at 2 months
Time frame: 2 months
Measured with Bagolini striated lens, Worth 4-dot test, and Synoptophore, respectively
Change from Baseline Stereopsis at 1 month
Time frame: 1 month
Measured with Synoptophore and Titmus stereo test, respectively
Change from Baseline Fusion at 1 month
Time frame: 1 month
Measured with Worth 4-dot test and Synoptophore, respectively
Change from Baseline Simultaneous Perception at 1 month
Time frame: 1 month
Measured with Bagolini striated lens, Worth 4-dot test, and Synoptophore,
3 secondary outcomes
Visual Acuity
Time frame: one year
Change from Baseline Deviation Degree at 1 year
Time frame: 1 year
Change from Baseline Refractive Error at 1 year
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Feb 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SJ-RS-WL2015 visual training program software in people with Intermittent Exotropia, run by Guangzhou Shijing Medical Software at 2 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 10 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from Baseline Stereopsis at 12 months (time frame: 12 months). The study lists 15 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Feb 2020.