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

NCT06250920 | Completed

• 1 other identifier: 4.1/20-260/01
• Study Type: interventional
• Target: 65
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Myopia; Myopia, Progressive

Outcome Measures

Primary Outcomes (1)

• changes in axial length

  baseline and the 3-month follow-up visits

Secondary Outcomes (1)

• changes in subfoveal choroidal thickness

  baseline and the 3-month follow-up visits.

Study Arms (2)

Virtual reality-based visual training group

EXPERIMENTAL

Device: Virtual reality visual training

Single-Vision Spectacle Group

NO INTERVENTION

Interventions

Virtual reality visual training DEVICE

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

Virtual reality-based visual training group

Eligibility Criteria

• Age: 8 Years - 13 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

• Existing or previous history of ophthalmic organic diseases, ophthalmic surgery, and obvious strabismus after wearing glasses;
• Using orthokeratology lenses, feeding instrument and other myopia prevention and control methods that may affect the study in the past 6 months;
• Subjects with poor vestibular function such as motion sickness and seasickness;
• 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.);

Sponsors & Collaborators

• Shanghai 10th People's Hospital: lead

Study Sites (1)

Shanghai Tenth People's Hospital

Shanghai, Shanghai Municipality, 270002, China

Location

Related Publications (1)

• Xu Z, Zou A, Li L, Wu Y, Cai W, Ma J, Yu J. Effect of virtual reality-based visual training for myopia control in children: a randomized controlled trial. BMC Ophthalmol. 2024 Sep 16;24(1):358. doi: 10.1186/s12886-024-03580-w.

  PMID: 39278928 DERIVED

MeSH Terms

Conditions

Myopia; Myopia, Degenerative

Condition Hierarchy (Ancestors)

Refractive Errors; Eye Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr

Study Record Dates

• First Submitted: February 1, 2024
• First Posted: February 9, 2024
• Study Start: December 1, 2020
• Primary Completion: August 30, 2021
• Study Completion: August 30, 2021
• Last Updated: February 9, 2024

Record last verified: 2024-02

Locations

CN (1)