Intermittent ExotropiaNCT06594666
Visual Training for Improving Intermittent Exotropia Visual Function
A study testing VR/AR visual training group in people with Intermittent Exotropia and Visual Functions, run by Shanghai Eye Disease Prevention and Treatment Center.
Trial summary
The goal of this clinical tral is to investigate that if VR/AR visual training can improve the visual function in children with intermittent exotropia. The main question it aims to answer is : Does the VR/AR visual training can enhance stereoscopic vision function in children with intermittent exotropia. Read more about this study
- Who is it for?
- Ages 6 to 14 years
- Conditions the study is for
- Intermittent Exotropia, Visual Functions
- What is being tested?
- VR/AR visual training group
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 78 participants
- Where
- No sites listed yet
- Study dates
- 15 Sep 2024to 28 Feb 2026
- 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 6 to 14 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Aged 6 to 14 years. Intermittent exotropia meeting all of the following criteria: Exodeviation at least 10Δ at distance measured by the prism and alternate cover test, near deviation does not exceed distance deviation by more than 10Δby prism and alternate cover test, mean distance Newcastle Control Score (NCS)≥2 points (mean of 3 assessments during the examination).
- Refractive error between -5.00 D < spherical equivalents (SEs) ≤ -1.00 D, astigmatism ≤1.50D, anisometropia ≤1.5D, best visual acuity in each eye of 1.0.
- Not receiving any other form of strabismus or myopia treatment within 3 months. Willing to follow the research plan and participate in the entire research process.
- Participants and guardians agree to be randomly assigned and sign an informed consent form.
Who cannot join
- Vertical strabismus; Diagnosed with other eye diseases or visual abnormalities such as strabismus, amblyopia, etc; Existence of cognitive or learning disabilities that may affect the effectiveness of training; patients with neurological disorders; Unable to cooperate with eye examination and follow-up work.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Clinical Study on the Effectiveness and Safety of Visual Training for Improving Intermittent Exotropia Visual Function
The goal of this clinical tral is to investigate that if VR/AR visual training can improve the visual function in children with intermittent exotropia.
The main question it aims to answer is :
Read more
Does the VR/AR visual training can enhance stereoscopic vision function in children with intermittent exotropia.
Researchers will compare intervention group to control group to see if VR/AR visual training could enhance stereoscopic vision function in children with intermittent exotropia.
Participants will:
The intervention group will receive 20 minutes of VR/AR visual training once a day for a period of one year.
Follow up check ups at the hospital every 3 months. Keep a diary of the values of stereoscopic vision function and Newcastle Control Score.
- Conditions
- Intermittent Exotropia, Visual Functions
- Being tested
- VR/AR visual training group
- Keywords
- visual training, visual function, intermittent exotropia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VR/AR visual training groupDevice
Wear glasses for correction combined with VR/AR visual training in the first 6 months, and terminate the training for follow-up observation in the last 6 months. Regular follow-up every 3 months, with a total follow-up time of 1 year.
| Study group | Role | What they receive |
|---|---|---|
| VR/AR visual training group | Experimental | Wear glasses for correction combined with VR/AR visual training in the first 6 months, and terminate the training for follow-up observation in the last 6 months. Regular follow-up every 3 months, with a total follow-up time of 1 year. Receives: Device: VR/AR visual training group |
| control group | No intervention | No intervention, simply wearing glasses for correction, followed up every 3 months for a total of 12 months. |
What is being measured
The primary outcome is the main question the study is designed to answer.
changes in stereoscopic vision function after 6 month
Compare whether the intervention group has better stereoscopic vision function than the control group after 6 months
Measured: 6 months after baseline
changes in stereoscopic vision function after 12 month
Stop the intervention group training after 6 months and observe for another 6 months to see if there will be a decrease in stereoscopic vision function.
Measured: 12 month after baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2024
- Study start15 Sep 2024 (estimated)
- Primary completion30 Nov 2025 (estimated)
- Study completion28 Feb 2026 (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
- None (open label)
- Enrolment
- 78 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Eye Disease Prevention and Treatment Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06594666
- Sponsor's protocol ID
- QX-2024-A-012
- Status last verified
- Sep 2024
- First submitted
- 10 Sep 2024
- Last updated
- 19 Sep 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Study on the Effectiveness and Safety of Visual Training for Improving Intermittent Exotropia Visual Function
- ClinicalTrials.gov ID
- NCT06594666
- Acronym / sponsor ID
- QX-2024-A-012
- Conditions
- Intermittent Exotropia, Visual Functions
- Keywords
- visual training, visual function, intermittent exotropia
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 78 participants (estimated)
- Lead sponsor
- Shanghai Eye Disease Prevention and Treatment CenterUniversity, hospital or other
- Study start
- 15 Sep 2024 (estimated)
- Primary completion
- 30 Nov 2025 (estimated)
- Study completion
- 28 Feb 2026 (estimated)
- First posted
- 19 Sep 2024 (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.
The goal of this clinical tral is to investigate that if VR/AR visual training can improve the visual function in children with intermittent exotropia.
The main question it aims to answer is :
Does the VR/AR visual training can enhance stereoscopic vision function in children with intermittent exotropia.
Researchers will compare intervention group to control group to see if VR/AR visual training could enhance stereoscopic vision function in children with intermittent exotropia.
Participants will:
The intervention group will receive 20 minutes of VR/AR visual training once a day for a period of one year.
Follow up check ups at the hospital every 3 months. Keep a diary of the values of stereoscopic vision function and Newcastle Control Score.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| VR/AR visual training group | Experimental | Device: VR/AR visual training groupWear glasses for correction combined with VR/AR visual training in the first 6 months, and terminate the training for follow-up observation in the last 6 months. Regular follow-up every 3 months, with a total follow-up time of 1 year. |
| control group | No intervention | –No intervention, simply wearing glasses for correction, followed up every 3 months for a total of 12 months. |
Who may qualify
- Ages
- 6 to 14 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Aged 6 to 14 years. Intermittent exotropia meeting all of the following criteria: Exodeviation at least 10Δ at distance measured by the prism and alternate cover test, near deviation does not exceed distance deviation by more than 10Δby prism and alternate cover test, mean distance Newcastle Control Score (NCS)≥2 points (mean of 3 assessments during the examination).
- Refractive error between -5.00 D < spherical equivalents (SEs) ≤ -1.00 D, astigmatism ≤1.50D, anisometropia ≤1.5D, best visual acuity in each eye of 1.0.
- Not receiving any other form of strabismus or myopia treatment within 3 months. Willing to follow the research plan and participate in the entire research process.
- Participants and guardians agree to be randomly assigned and sign an informed consent form.
Key exclusion criteria (1 listed)
- Vertical strabismus; Diagnosed with other eye diseases or visual abnormalities such as strabismus, amblyopia, etc; Existence of cognitive or learning disabilities that may affect the effectiveness of training; patients with neurological disorders; Unable to cooperate with eye examination and follow-up work.
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 |
|---|---|---|
| VR/AR visual training groupWear glasses for correction combined with VR/AR visual training in the first 6 months, and terminate the training for follow-up observation in the last 6 months. Regular follow-up every 3 months, with a total follow-up time of 1 year. | Device | VR/AR visual training group |
Primary outcome
changes in stereoscopic vision function after 6 month
Time frame: 6 months after baseline
Compare whether the intervention group has better stereoscopic vision function than the control group after 6 months
changes in stereoscopic vision function after 12 month
Time frame: 12 month after baseline
Stop the intervention group training after 6 months and observe for another 6 months to see if there will be a decrease in stereoscopic vision function.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2024.
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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.
Questions about this trial
What is this clinical trial studying?
A study testing VR/AR visual training group in people with Intermittent Exotropia and Visual Functions, run by Shanghai Eye Disease Prevention and Treatment Center.
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 1 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 19 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
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?
Contact Wei Xu, PhD (+86-18521513008, vvxuwei@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
changes in stereoscopic vision function after 6 month (time frame: 6 months after baseline). The study lists 2 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 19 Sep 2024.