Visual Training for Improving Intermittent Exotropia Visual Function

NCT06594666 | Not Yet Recruiting DMC

• 1 other identifier: QX-2024-A-012
• Study Type: interventional
• Target: 78
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Intermittent Exotropia; Visual Functions

Keywords

visual training; visual function; intermittent exotropia

Outcome Measures

Primary Outcomes (2)

• 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

  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.

  12 month after baseline

Study Arms (2)

VR/AR visual training group

EXPERIMENTAL

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

control group

NO INTERVENTION

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

Interventions

VR/AR visual training group 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.

VR/AR visual training group

Eligibility Criteria

• Age: 6 Years - 14 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Shanghai Eye Disease Prevention and Treatment Center: lead

Central Study Contacts

Wei Xu, PhD

CONTACT

+86-18521513008; vvxuwei@163.com

Qiurong Lin, PhD

CONTACT

+86-15216698330; oculist_qiurong@126.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 10, 2024
• First Posted: September 19, 2024
• Study Start: September 15, 2024
• Primary Completion: November 30, 2025
• Study Completion: February 28, 2026
• Last Updated: September 19, 2024

Record last verified: 2024-09