Visual Training for Improving Intermittent Exotropia Visual Function (NCT06594666) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Visual Training for Improving Intermittent Exotropia Visual Function
78 participantsStarted 2024-09-15
Plain-language 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.
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.
Who can participate
Age range
6 Years – 14 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
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.
Exclusion Criteria:
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
changes in stereoscopic vision function after 6 month
Timeframe: 6 months after baseline
2
changes in stereoscopic vision function after 12 month
Timeframe: 12 month after baseline
Trial details
NCT IDNCT06594666
SponsorShanghai Eye Disease Prevention and Treatment Center