Brain Visual Perception Training for Prevention and Control of Premyopia

NCT ID: NCT06585657

Last Updated: 2024-09-19

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 156 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-09-15
• Study Completion Date: 2026-03-31

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

brain visual perception training group

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

Group Type: EXPERIMENTAL

brain visual perception training group

Intervention Type: 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.

control group

no intervention

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

brain visual perception training group

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

Intervention Type: DEVICE

Eligibility Criteria

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.

• Minimum Eligible Age: 6 Years
• Maximum Eligible Age: 10 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Shanghai Eye Disease Prevention and Treatment Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Central Contacts

Wei Xu, PhD

Role: CONTACT

vvxuwei@163.com

+8618521513008

Haidong Zou, PhD

Role: CONTACT

zouhaidong@sjtu.edu.cn

+8613311986528

Other Identifiers

QX-2024-A-011

Identifier Type: -

Identifier Source: org_study_id