Visual Training for Improving Intermittent Exotropia Visual Function

Not Applicable

Not yet recruiting

• Conditions: Intermittent Exotropia; Visual Functions
• Interventions: Device: VR/AR visual training group

• Registration Number: NCT06594666
• Lead Sponsor: Shanghai Eye Disease Prevention and Treatment Center

Brief 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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-09
• Study First Submitted: 2024-09-10
• Study First Submitted QC: 2024-09-10
• Last Update Submitted: 2024-09-10
• Study First Posted: 2024-09-13
• Last Update Posted: 2024-09-13
• Study Start: 2024-09-15
• Primary Completion: 2025-11-30
• Study Completion: 2026-02-28

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 78

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
VR/AR visual training group	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

Name	Time	Method
changes in stereoscopic vision function after 6 month	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	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.