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

Myopia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06250920
• Other study ID #: 4.1/20-260/01
• Status: Completed
• Phase: N/A
• Start date: December 1, 2020
• Est. completion date: August 30, 2021

Study information

• Verified date: February 2024
• Source: Shanghai 10th People's Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 65
• Est. completion date: August 30, 2021
• Est. primary completion date: August 30, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 8 Years to 13 Years

Eligibility

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.

Related Conditions & MeSH terms

• Myopia
• Myopia, Degenerative
• Myopia, Progressive

Intervention

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

Locations

Country	Name	City	State
China	Shanghai Tenth People's Hospital	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Shanghai 10th People's Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	changes in axial length		baseline and the 3-month follow-up visits
Secondary	changes in subfoveal choroidal thickness		baseline and the 3-month follow-up visits.