Visual Training for Improving Intermittent Exotropia Visual Function

NCT ID: NCT06594666

Last Updated: 2024-09-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

78 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-09-15

Study Completion Date

2026-02-28

Brief Summary

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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

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Conditions

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Intermittent Exotropia Visual Functions

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

VR/AR visual training group

Intervention Type DEVICE

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.

control group

No intervention, simply wearing glasses for correction, followed up every 3 months for a total of 12 months.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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.

Intervention Type DEVICE

Eligibility Criteria

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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.
Minimum Eligible Age

6 Years

Maximum Eligible Age

14 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Shanghai Eye Disease Prevention and Treatment Center

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Central Contacts

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Wei Xu, PhD

Role: CONTACT

+86-18521513008

Qiurong Lin, PhD

Role: CONTACT

+86-15216698330

Other Identifiers

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QX-2024-A-012

Identifier Type: -

Identifier Source: org_study_id

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