NCT Number: NCT06594666
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.
Trial opening soon.
Get Notified6 year–14 year
All sexes
Interventional
Not applicable
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
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.
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.
Time frame: 6 months after baseline
Compare whether the intervention group has better stereoscopic vision function than the control group after 6 months
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.
Contact information is provided by the study sponsor or research team.
Qiurong Lin, PhD
CONTACT
Wei Xu, PhD
CONTACT
Shanghai Eye Disease Prevention and Treatment Center
Other
Clinical Study on the Effectiveness and Safety of Visual Training for Improving Intermittent Exotropia Visual Function
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT07642934
Eye Diseases, Intermittent Exotropia
View Trial DetailsNCT06762067
Cranial Nerve Diseases, Exercise Training
View Trial DetailsNCT02807350
Intermittent Exotropia
Birmingham, Alabama, United States
View Trial DetailsNCT05462821
Intermittent Exotropia
Birmingham, Alabama, United States
View Trial Details