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NCT Number: NCT06585657

Brain Visual Perception Training for Prevention and Control of Premyopia

The goal of this clinical trial is to investigate whether brain visual perception training can effectively prevent myopia in children with pre myopia. It will also learn about the safety of brain visual perception training.

The main questions it aims to answer are: Does brain visual perception training slow down the growth of axial length? What medical issues may participants encounter when using the brain visual perception training system? Researchers will compare participants who receive brain visual perception training with a control group to see if the training group can delay the onset of pre myopia in children Participants will: The training group will receive 20 minutes of brain visual perception 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 axial length and refractive diopter.

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Key information

Conditions

Visual Function Myopia Progressing

Age range

6 year–10 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Children aged 6-10 years with premyopia, defined as a cycloplegic spherical equivalent refraction (SER) of the more myopic eye in the range of -0.50 to 0.75 (inclusive) diopters (D) and having at least 1parent with an SER in either eye of -3.00D or less.

Exclusion criteria

Children have astigmatism of 1.50D or more, anisometropia of 1.50 D or more, strabismus and other ocular abnormalities, any systemic diseases, or a history of any myopia interventions.

Treatment and study plan

brain visual perception training group

Device

Conduct brain visual perception training through a visual training system to improve binocular visual balance. Train 2 projects per day, each lasting 10 minutes.

Primary outcomes

  1. changes in axial length after 1 year

    Time frame: 1 year after the baseline

    the difference in the changes of axial length between the intervention group and the control group

Secondary outcomes

  1. changes in cycloplegic spherical equivalent after 1year

    Time frame: 1 year after the baseline

    the difference in the changes of cyclopegic spherical equivalent between the intervention group and the control group

Study contacts

Contact information is provided by the study sponsor or research team.

Haidong Zou, PhD

CONTACT

[email protected]

+8613311986528

Wei Xu, PhD

CONTACT

[email protected]

+8618521513008

Sponsors and collaborators

Lead sponsor

Shanghai Eye Disease Prevention and Treatment Center

Other

Registry information

Official study title

Clinical Study on Brain Visual Perception Training for Prevention and Control of Myopia in Children with Premyopia

Important dates

Study start
2024
Primary completion
2025
Study completion
2026
First posted
Sep 5, 2024
Registry last updated
Sep 19, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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