Visual Training for Improving Intermittent Exotropia Visual Function
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: VR/AR visual training group.
- Who it may be relevant to
- Registry conditions: Intermittent Exotropia, Visual Functions. Basic parameters: 6 years — 14 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Clinical Study on the Effectiveness and Safety of Visual Training for Improving Intermittent Exotropia Visual Function
Overview
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.
Interventions
- Device VR/AR visual training group
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.
Primary outcome measures
- changes in stereoscopic vision function after 6 month [Time frame: 6 months after baseline]
- changes in stereoscopic vision function after 12 month [Time frame: 12 month after baseline]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT06594666 · QX-2024-A-012