An interventional study of VR/AR visual training group in Intermittent Exotropia and Visual Functions, sponsored by Shanghai Eye Disease Prevention and Treatment Center. Not yet recruiting. Open to participants aged 6 Years to 14 Years. Per ClinicalTrials.gov, last updated 2024-09-19.
Sponsored by Shanghai Eye Disease Prevention and Treatment Center · Not applicable, Interventional, and Treatment
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.
58 studies on the registry are indexed under Exotropia; 13 are open to participants now.
This study's planned enrollment of 78 is above the median of 50 across 49 interventional studies indexed under Exotropia.
Browse Exotropia studies →Shanghai Eye Disease Prevention and Treatment Center is the lead sponsor of 66 studies on the registry; 30 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
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 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.
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Device: VR/AR visual training group
No intervention, simply wearing glasses for correction, followed up every 3 months for a total of 12 months.
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.
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
Time frame: 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.
Time frame: 12 month after baseline
No study locations are listed for this record.
Start is estimated for Sep 2024; primary completion for Nov 2025, 14 months later.
Of 29 interventional studies with no phase under Exotropia, half reached primary completion within 17 months of starting (the median), counting those still running; a quarter within 11 and three quarters within 46. This study's planned 14 months is below that.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Sep 2024. You cannot join it, but the record below documents what was studied.
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Shanghai Eye Disease Prevention and Treatment Center