Amblyopia
Conditions
Interventions
Control Group:Partly Patching
Sponsors
Eye and ENT Hospital of Fudan University
Eligibility
Sex/Gender
All
Age
4 Years to 8 Years
Inclusion criteria
Inclusion criteria: 1. The age is 4 years old (inclusive) to 9 years old (exclusive), male or female; 2. Amblyopia (previously treated or untreated) associated with strabismus, anisometropia, or both; 3. Refractive error correction is mandatory if any of the following are true (based on cycloplegic dilated refraction results completed within the past 7 months): (1) Hyperopia: hyperopia with spherical equivalent (SE) 2.50D or above (>= +2.50 D); (2) Myopia: myopia with spherical equivalent (SE) -0.50D or above (>= -0.50 D); (3) Astigmatism: 1.00D and above astigmatism (>= 1.00 D); 4) Anisometropia: Anisometropia with spherical equivalent power exceeding 0.50D (> 0.50 D); 4. Vision: (1) The visual acuity of the amblyopic eye is 20/32 to 20/100 (inclusive); (2) The best corrected visual acuity of the dominant eye/dominant eye meets the following criteria: 1) 4 years old: Lea symbol eye chart examination shows 20/40 or higher (according to ATS inspection process); 2) 5 years old and above, eyesight should be 20/32 or higher: = 2 lines (according to the Lea symbol eye chart inspection process of ATS); 5. Under the existing correction method, the deviation of the eye position of the strabismus eye when looking at near is 4?, it is forbidden to enter the group; 6. Pass a specially set 10-minute device performance test to ensure proper eye tracking performance (eye tracking data validity > 90%, and successful calibration can be achieved); 7. Subjects and family members can ensure to participate in all clinical visits during the study period; 8. The subject is in good general health, and can abide by the study visit time and study procedures according to the researcher's decision, and wear refractive correction devices, and at the same time can ensure access to wireless Internet at home to support CureSight treatment; 9. Sign and date the informed consent form; 10. Parents and participants understand and are willing to follow the study procedures and will follow the study time during the study.
Exclusion criteria
Exclusion criteria: 1. For myopic patients, the spherical equivalent power of any eye is greater than -6.00D; 2. The skin is known to have an uncomfortable reaction to the patch or bandage adhesive; 3. According to the investigator's judgment, any other potential reasons that may lead to a decrease in BCVA; 4. Severe developmental delay that would interfere with treatment or evaluation (as assessed by the investigator). Subjects with mild language delay or reading and/or learning disabilities are not excluded; 5. Treatment history of low compliance with amblyopia treatment informally assessed by the investigator; 6. The subject does not wear glasses (assessed by the investigator); 7. History of light-induced epilepsy; 8. Wear rigid breathable contact lenses; 9. Any reported ocular anatomical abnormalities (for example, partial opacity of the lens, myelinated nerve fibers, etc.); 10. History of previous intraocular surgery or refractive surgery; 11. Any situation that may prevent the subject from completing the daily continuous 45-90 minutes of training in front of the close-up monitor. For example, according to parental reports, subjects dislike or are unable to watch TV/movies for more than 60 minutes per day; 12. Always see strabismus with near eye deviation >= 10? (measured by PACT).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Best Corrected Visual Acuity (distance); | — |
Secondary
| Measure | Time frame |
|---|---|
| Best Corrected Visual Acuity (near);Stereopsis; | — |
Countries
China
Contacts
Public ContactRui Liu
Eye and ENT Hospital of Fudan University
Outcome results
None listed