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To evaluate the efficacy and safety of Eyetronix Flicker Glassess therapy in treating anisometropic amblyopia.
A total of 176 children with anisometropic amblyopia, aged 4 to 13 years, will randomize to receive patching or Eyetronix Flicker Glasses treatment in a 1:1 ratio.Eyetronix Flicker Glasses, a lightweight spectacle frame with liquid crystal lenses that provide direct square-wave alternating occlusion, will be used at a pre-programmed temporal frequency. Patching is a traditional treatment of amblyopia. The best corrected visual acuity, contrast sensitivity, binocular function,visual evoked potential and functional MRI will be measured at baseline and follow-up visits to assess the improvement of amblyopia.Feedback information from the questionnaires will be used to evaluate the compliance and adverse effects.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| EFG group | Experimental | amblyopia in EFG group will receive Eyetronix Flicker Glassess treatment. |
|
| Patching group | Active Comparator | amblyopia in patching group will receive patching treatment. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| EFG group | Device | 88 anisometropic amblyopia will be recruited to receive Eyetronix Flicker Glasses treatment. |
|
| Measure | Description | Time Frame |
|---|---|---|
| best corrected visual acuity | have an improvement of best corrected visual acuity in the amblyopic eyes | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| stereocuity | have an improvement of stereocuity in the amblyopic eyes | 6 months |
| contrast sensitivity function | have an improvement of contrast sensitivity in the amblyopic eyes |
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Inclusion Criteria:
Exclusion Criteria:
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| ID | Term |
|---|---|
| D000550 | Amblyopia |
| ID | Term |
|---|---|
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D014786 | Vision Disorders |
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| Patching group | Device | 88 anisometropic amblyopia will be recruited to receive patching treatment. |
|
| 6 months |
| visual evoked potential | P100 latency decrease and N75-P100 amplitude increase in the amblyopic eye. | 6 months |
| functional MRI | the visual cortex activity have an improvement | 6 months |
| best corrected visual acuity | have an improvement of best corrected visual acuity in the amblyopic eyes | a year and a half |
| D012678 | Sensation Disorders |
| D009461 | Neurologic Manifestations |
| D005128 | Eye Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |