amblyopia and insufficiency of fusion function in non-ocular organic diseases
Conditions
Interventions
Traditional occlusion therapy:Traditional occlusion therapy
Augmented Reality Amblyopia Training Treatment Software:Augmented Reality Amblyopia Training Treatment Software
Sponsors
Eye & ENT hospital of Fudan University
Eligibility
Sex/Gender
All
Age
5 Years to 55 Years
Inclusion criteria
Inclusion criteria: 1. Aged 5 to 55 years (including 5 years and 55 years), male or female; 2.Those with a difference of 0.2 LogMAR or more in the best-corrected visual acuity between two eyes, accompanied by amblyopia risk factors, with a clear diagnosis of amblyopia (Note: For the diagnosis methods and criteria for different types of amblyopia in young children, refer to the Chinese Expert Consensus on Prevention and Treatment of Amblyopia in Children (2021) by the Strabismus and Pediatric Ophthalmology Group of the Chinese Ophthalmological Society [1]); 3. Those who have a best-corrected visual acuity of < 1.0 LogMAR in the amblyopic eye; 4. Those who have applied optical refractive correction for more than 3 months for any refractive error; 5. Those who are able to understand the purpose of the trial, willing to participate in the trial, and the ICF has been signed by the subjects or their legal guardians; 6. Those who have orthophoric binocular alignment, or those who with strabismic amblyopia have orthophoric binocular alignment or have intermittent exotropia within a range of -15 to 0 Prism Diopters (PD) as measured by the prism cover test after strabismus correction.
Exclusion criteria
Exclusion criteria: 1. Those with organic eye diseases (e.g., ptosis, media opacity, nystagmus, paracentral fixation, acute inflammation such as keratitis, optic nerve diseases like glaucoma, retinal diseases, cortical visual impairment, etc.); 2. Those with tumors, hypertension, or heart disease; 3. Those with implantable electronic device; 4. Those with a history of ocular surgery (excluding strabismus surgery) that affects vision; 5. Those who have received amblyopia therapy (excluding eyeglasses) within 2 weeks prior to screening; 6. Those with epilepsy or psychiatric history or cognitive impairment; 7. Those with known allergies to skin patches or adhesive bandages; 8. Those who are currently using or need to use medications during the study period that may affect vision (excluding atropine used during pupil dilation procedure); 9. Those who are unable to pass the software test and enter formal training treatment after five test training sessions; 10. Those who may experience discomfort or are unable to tolerate the test training and subsequent treatment with the Augmented Reality Amblyopia Training Treatment Software; 11. Those who had participated in clinical trials for other drugs within 3 months prior to screening, or who had participated in clinical trials for other medical devices within 30 days; 12. Those who are unable to follow medical instructions for treatment and follow-up requirements; 13. Pregnant or breastfeeding women, or women of childbearing age planning to become pregnant; 14. Other conditions in which the investigators deem it inappropriate to participate in this clinical trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Clinical effective rate of amblyopia treatment at 13 weeks after treatment; | — |
Secondary
| Measure | Time frame |
|---|---|
| Changes in contrast sensitivity;Changes in stereopsis;Clinical effective rate of amblyopia treatment at 2 weeks, 4 weeks and 9 weeks after treatment;Evaluation of functionality and usability of augmented reality amblyopia training software;AE \ SAE \ Device Defective; | — |
Countries
China
Contacts
Public ContactWen Wen; Zhao Chen
Eye & ENT hospital of Fudan University
Outcome results
None listed