Brain Visual Perception Training for Prevention and Control of Premyopia

NCT06585657 | Not Yet Recruiting

• 1 other identifier: QX-2024-A-011
• Study Type: interventional
• Target: 156
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Visual Function; Myopia Progressing

Keywords

brain visual perception training; premyopia

Outcome Measures

Primary Outcomes (1)

• changes in axial length after 1 year

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

  1 year after the baseline

Secondary Outcomes (1)

• changes in cycloplegic spherical equivalent after 1year

  1 year after the baseline

Study Arms (2)

brain visual perception training group

EXPERIMENTAL

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

Device: brain visual perception training group

control group

NO INTERVENTION

no intervention

Interventions

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.

brain visual perception training group

Eligibility Criteria

• Age: 6 Years - 10 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Shanghai Eye Disease Prevention and Treatment Center: lead

Central Study Contacts

Wei Xu, PhD

CONTACT

+8618521513008; vvxuwei@163.com

Haidong Zou, PhD

CONTACT

+8613311986528; zouhaidong@sjtu.edu.cn

Study Design

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

Study Record Dates

• First Submitted: September 3, 2024
• First Posted: September 5, 2024
• Study Start: September 15, 2024
• Primary Completion: December 31, 2025
• Study Completion: March 31, 2026
• Last Updated: September 19, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share