Effect of Virtual Reality-Based Visual Training for Myopia Control in Children

Effect of Virtual Reality-Based Visual Training for Myopia Control in Children: a Randomized Controlled Trial

To assess the efficacy and safety of virtual reality-based visual training (VRVT) in myopia control among children.

Study Overview

• Status: Completed
• Conditions: Myopia; Myopia, Progressive
• Intervention / Treatment: Device: Virtual reality visual training

• Study Type: Interventional
• Enrollment (Actual): 65
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Shanghai
    • Shanghai, Shanghai, China, 270002
      • Shanghai Tenth People's Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Age 8-13 years old (inclusive), regardless of gender;
2. The spherical equivalent of both eyes after cycloplegia was -3.00D to -0.50D (including);
3. Binocular astigmatism ≤3.00D during screening;
4. Anisometropia (according to spherical equivalent) ≤1.50D during screening;
5. The intraocular pressure of any eye during screening was ≤21mmHg;
6. At the time of screening, the best corrected distance visual acuity of any eye was ≥1.0 or LogMAR≤0;
7. Good binocular stereopsis and stereopsis acuity ≤60 ";
8. The subjects and their legal guardians were willing to participate in the study and signed written informed consent.

Exclusion Criteria:

1. Existing or previous history of ophthalmic organic diseases, ophthalmic surgery, and obvious strabismus after wearing glasses;
2. Using orthokeratology lenses, feeding instrument and other myopia prevention and control methods that may affect the study in the past 6 months;
3. Subjects with poor vestibular function such as motion sickness and seasickness;
4. Any history of diseases or syndromes that may cause severe myopia (e.g., Marfan syndrome, Stickler syndrome, retinopathy of prematurity, etc.); 5, any eye refractive media abnormalities (such as cornea, lens abnormalities, etc.);

6. Long-term use (i.e., more than 7 consecutive days in 1 month or more than 30 days in total in 1 year) of any local or systemic use of anticholinergic/anticholinergic drugs (e.g., atropine, scopolamine, tolacamide, etc.) within 21 days before screening and during the expected period of the study, allowing the use of cycloplegic drops for optometry and other examinations; 7. Severe systemic disease considered by the investigator as not suitable for the study; 8. Participation in other clinical trials within 30 days before screening; 9. Only one eye met the inclusion criteria; 10. Poor compliance, unable to go to medical institutions for treatment on a timely and regular basis as required; 11. Any other circumstances deemed inappropriate by the investigator to participate in the study.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Virtual reality-based visual training group	Device: Virtual reality visual training; Children in intervention group were administered at home under the supervision of parents for 20 minutes per session every day with virtual reality visual training
No Intervention: Single-Vision Spectacle Group

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
changes in axial length	baseline and the 3-month follow-up visits

Secondary Outcome Measures

Outcome Measure	Time Frame
changes in subfoveal choroidal thickness	baseline and the 3-month follow-up visits.

Collaborators and Investigators

• Sponsor: Shanghai 10th People's Hospital

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2020
• Primary Completion (Actual): August 30, 2021
• Study Completion (Actual): August 30, 2021

Study Registration Dates

• First Submitted: February 1, 2024
• First Submitted That Met QC Criteria: February 8, 2024
• First Posted (Estimated): February 9, 2024

Study Record Updates

• Last Update Posted (Estimated): February 9, 2024
• Last Update Submitted That Met QC Criteria: February 8, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Refractive Errors; Myopia; Myopia, Degenerative
• Other Study ID Numbers: 4.1/20-260/01

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No