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Completed

NCT Number: NCT06250920

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

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

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Key information

Age range

8 year–13 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Shanghai Tenth People's Hospital

Shanghai, Shanghai Municipality, 270002, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.);
  • 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.

Treatment and study plan

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

Primary outcomes

  1. changes in axial length

    Time frame: baseline and the 3-month follow-up visits

Secondary outcomes

  1. changes in subfoveal choroidal thickness

    Time frame: baseline and the 3-month follow-up visits.

Sponsors and collaborators

Lead sponsor

Shanghai 10th People's Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Feb 9, 2024
Registry last updated
Feb 9, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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