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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

65 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-12-01

Study Completion Date

2021-08-30

Brief Summary

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

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Detailed Description

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Conditions

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Myopia Myopia, Progressive

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Caregivers Outcome Assessors

Study Groups

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Virtual reality-based visual training group

Group Type EXPERIMENTAL

Virtual reality visual training

Intervention Type 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

Single-Vision Spectacle Group

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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

Intervention Type DEVICE

Eligibility Criteria

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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.);

Minimum Eligible Age

8 Years

Maximum Eligible Age

13 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No