Children amblyopia
Conditions
Interventions
Experimental group:Red blue amblyopia treatment software
Sponsors
Zhongshan Ophthalmic Center,Sun Yat-sen Universuty/Eye Hospital,Wenzhou Medical University
Eligibility
Sex/Gender
All
Age
5 Years to 12 Years
Inclusion criteria
Inclusion criteria: 1. Aged 5-12, both sexes; 2. Subjects with a definite diagnosis of amblyopia, or a binocular best corrected visual acuity difference of 2 lines or more; 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 be uncomfortable or unable to tolerate the test training and subsequent treatment of the red-blue 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 ; | — |
Countries
China
Contacts
Public ContactXinping Yu/Xudong Yu
Zhongshan Ophthalmic Center, Sun Yat-sen University/Eye Hospital,Wenzhou Medical University
Outcome results
None listed