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

Not Applicable

• Conditions: Amblyopia, Anisometropic
• Interventions: Device: EFG group; Device: Patching group

• Registration Number: NCT02970708
• Lead Sponsor: Shanghai Eye Disease Prevention and Treatment Center

Brief Summary

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

Detailed Description

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.

Study Timeline

• Status Verified: 2016-11
• Study First Submitted: 2016-11-17
• Study First Submitted QC: 2016-11-17
• Last Update Submitted: 2016-11-17
• Study First Posted: 2016-11-22
• Last Update Posted: 2016-11-22
• Study Start: 2017-01
• Primary Completion: 2017-06
• Study Completion: 2020-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 176

Inclusion Criteria

1. aged from 4 to 13 years old
2. 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
3. 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.
4. no amblyopia treatment one month prior to the study except refractive correction.
5. myopia is less than -6.00D or hyperopia is less than +9.00D, strabismus was less than 20 prism diopters
6. willing to participate in this study and be able to follow up on time

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Exclusion Criteria

1. ocular disease and other disease that have an influence on the visual acuity
2. history of ocular surgery that have an influence on the visual acuity
3. the patient is receiving other amblyopia treatment except refractive correction
4. a family or personal history of seizures
5. the patient is using some medicine that may have an influence on visual acuity

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
EFG group	EFG group	amblyopia in EFG group will receive Eyetronix Flicker Glassess treatment.
Patching group	Patching group	amblyopia in patching group will receive patching treatment.

Primary Outcome Measures

Name	Time	Method
best corrected visual acuity	6 months	have an improvement of best corrected visual acuity in the amblyopic eyes

Secondary Outcome Measures

Name	Time	Method
contrast sensitivity function	6 months	have an improvement of contrast sensitivity in the amblyopic eyes
visual evoked potential	6 months	P100 latency decrease and N75-P100 amplitude increase in the amblyopic eye.
functional MRI	6 months	the visual cortex activity have an improvement
stereocuity	6 months	have an improvement of stereocuity in the amblyopic eyes
best corrected visual acuity	a year and a half	have an improvement of best corrected visual acuity in the amblyopic eyes