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Visual Training for Improving Intermittent Exotropia Visual Function

Clinical Study on the Effectiveness and Safety of Visual Training for Improving Intermittent Exotropia Visual Function

Status
Not yet recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06594666
Enrollment
78
Registered
2024-09-19
Start date
2024-09-15
Completion date
2026-02-28
Last updated
2024-09-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Intermittent Exotropia, Visual Functions

Keywords

visual training, visual function, intermittent exotropia

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.

Interventions

DEVICEVR/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.

Sponsors

Shanghai Eye Disease Prevention and Treatment Center
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
6 Years to 14 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
changes in stereoscopic vision function after 6 month6 months after baselineCompare whether the intervention group has better stereoscopic vision function than the control group after 6 months
changes in stereoscopic vision function after 12 month12 month after baselineStop 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.

Contacts

Primary ContactWei Xu, PhD
vvxuwei@163.com+86-18521513008
Backup ContactQiurong Lin, PhD
oculist_qiurong@126.com+86-15216698330

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026