Children amblyopia
Conditions
Interventions
Experimental group:Virtual reality amblyopia treatment software
Control group:Traditional covering therapy
Sponsors
Sun Yat-sen University Zhongshan Ophthalmic Center
Eligibility
Sex/Gender
All
Age
5 Years to 12 Years
Inclusion criteria
Inclusion criteria: 1. Aged 5-12 years, both sexes; 2. Subjects with a clear diagnosis of amblyopia and a binocular best corrected visual acuity difference of 2 rows or more; (Note: The diagnostic methods and criteria for different types of amblyopia in young children are detailed in the Expert Consensus on Prevention and treatment of amblyopia in Chinese Children, Strabismus and Pediatric Ophthalmology Group, Chinese Ophthalmology Society, Chinese Medical Association (2021)); 3. Subjects with monocular best corrected visual acuity > 0.1 (fractional visual acuity); 4. Requirements for wearing glasses: wear glasses for more than 1 month; 5. The subject and his/her guardian sign the informed consent and participate voluntarily.
Exclusion criteria
Exclusion criteria: 1. Patients with organic diseases of the eye and other parts (such as blepharoptosis, refractive medium opacity, fundus or optic neuropathy, cortical vision disorders, etc.); 2. Patients with a history of eye surgery that affects vision; 3. Subjects who had received treatment for amblyopia within 3 months before screening (except glasses); 4. Patients with photosensitive epilepsy; 5. A known allergy to skin patch or bandage adhesive; 6. Those who are using or need to use drugs that may affect vision during the study; 7. Subjects who still cannot enter the system for formal training and treatment through software testing after 5 times of testing and training; 8. Subjects who may have discomfort or intolerance in the testing training and subsequent treatment of virtual reality amblyopia treatment software; 9. Participating in clinical trials of other drugs within 3 months before screening and clinical trials of other medical devices within 30 days; 10. Persons with severe communication difficulties; 11. Failing to follow medical advice for treatment and follow-up; 12. Wearer of rigid breathable contact lens; 13. Other conditions deemed inappropriate by the investigator to participate in the clinical trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The clinical effective rate was 13 weeks in treatment of amblyopia; | — |
Secondary
| Measure | Time frame |
|---|---|
| Sensitivity;Far and near stereopsis; | — |
Countries
China
Contacts
Public ContactJinrong Li
Sun Yat-sen University Zhongshan Ophthalmic Center
Outcome results
None listed