Clinical trial NCT06250920: Effect of Virtual Reality-Based Visual Training for Myopia Control in Children
Official title: Effect of Virtual Reality-Based Visual Training for Myopia Control in Children: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Myopia
Myopia, Progressive
Lead sponsor: Shanghai 10th People's Hospital
Sponsor class: OTHER
First posted: 2024-02-09
Enrollment: 65
Sex: ALL
Minimum age (years): 8
Maximum age (years): 13
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


Eligibility criteria: 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.

Primary outcomes:
measure: changes in axial length
timeFrame: baseline and the 3-month follow-up visits
Secondary outcomes:
measure: changes in subfoveal choroidal thickness
timeFrame: baseline and the 3-month follow-up visits.
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Shanghai Tenth People's Hospital
state: Shanghai
Study officials:
References: