Ophthalmology
Conditions
Interventions
control group:standard patches
Experimental group:????????
Sponsors
Shanghai General Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Aged 4 to 13 years; 2. Definite genetic diagnosis of anisometropic amblyopia, best-corrected visual acuity (BCVA) of the amblyopic eye equal to or worse than 0.3 (logMAR) in 3–5 years age range and 0.15 (logMAR) in children over 6 years old, at least a two-line BVCA difference between the two eyes (according to the diagnostic criteria for amblyopia established by the Ophthalmology branch of the Chinese Medical Association in 2011); 3. Myopia of no more than -6.00 diopters (D), hypermetropia of no more than +9.00 D, astigmatism of less than 3.00 D, anisometropia of at least 1.50 D spherical equivalent or at least 1.00 D cylindrical equivalent; 4. Strabismus of no more than 20 prism diopters (?) according to prism and alternate cover test (PACT); 5. Better than a 0.7 logMAR BVCA of the amblyopic eye; 6. The subjects and their parents / guardians voluntarily participated in the study and signed informed consent.
Exclusion criteria
Exclusion criteria: 1. Ocular diseases, such as ptosis, refractive media opacity, fundus disease and optic neuropathy; 2. History of interocular or refractive surgery that affects vision; 3. History of treatment for amblyopia in the last three months before screening (except spectacle frames); 4. Photo sensitivity epilepsy; 5. Confirmed or suspected conjunctivitis; 6. Allergy or intolerance to the test equipment or patch; 7. History of pharmacological intervention that may affect vision such as atropine; 8. Participation in another clinical study/trial within one month before the enrollment of the study; 9. Patients who are unable to communicate or do not follow the instructions; 10. Other situations that the researchers consider unsuitable for clinical trials.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Best-corrected visual acuity;contrast sensitivity;stereopsis;fusion range; | — |
Countries
China
Contacts
Public ContactXudong Yu
Outcome results
None listed