Efficacy and Safety of Eyetronix Flicker Glasses to the Treatment of Anisometropic Amblyopia

Study Overview
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Brief Summary
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To evaluate the efficacy and safety of Eyetronix Flicker Glassess therapy in treating anisometropic amblyopia.

Detailed Description
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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.

Official Title
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Efficacy and Safety of Eyetronix Flicker Glasses to the Treatment of Anisometropic Amblyopia in Chinese Children

Conditions
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Amblyopia, Anisometropic

Intervention / Treatment
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* Device: EFG group
* Device: Patching group


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: aged from 4 to 13 years old the best corrected visual acuity in the amblyopic eye is no more than 0.1logMAR, with two lines or more of difference between the two eyes anisometropia is defined as an inter-ocular spherical refractive error difference of 1.00 D or more or a cylindrical difference of 1.50 D or more. no amblyopia treatment one month prior to the study except refractive correction. myopia is less than -6.00D or hyperopia is less than +9.00D, strabismus was less than 20 prism diopters willing to participate in this study and be able to follow up on time Exclusion Criteria: ocular disease and other disease that have an influence on the visual acuity history of ocular surgery that have an influence on the visual acuity the patient is receiving other amblyopia treatment except refractive correction a family or personal history of seizures the patient is using some medicine that may have an influence on visual acuity

Ages Eligible for Study
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Minimum Age: 4 Years
Maximum Age: 13 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: EFG group<br>amblyopia in EFG group will receive Eyetronix Flicker Glassess treatment. | Device: EFG group<br>* 88 anisometropic amblyopia will be recruited to receive Eyetronix Flicker Glasses treatment.<br>|
| Active Comparator: Patching group<br>amblyopia in patching group will receive patching treatment. | Device: Patching group<br>* 88 anisometropic amblyopia will be recruited to receive patching treatment.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| best corrected visual acuity | have an improvement of best corrected visual acuity in the amblyopic eyes | 6 months | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 |