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

Shanghai Eye Disease Prevention and Treatment Center

Status: Unknown

Conditions: Amblyopia, Anisometropic

Treatments: Device: Patching group; Device: EFG group

Study type: Interventional

Funder types: Other

Identifiers

NCT02970708

YFZX2016001

Details and patient eligibility

About

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

Full 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.

Enrollment: 176 estimated patients

Sex: All

Ages: 4 to 13 years old

Volunteers: No Healthy Volunteers

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

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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176 participants in 2 patient groups

EFG group

Experimental group

Description:

amblyopia in EFG group will receive Eyetronix Flicker Glassess treatment.

Treatment:

Device: EFG group

Patching group

Active Comparator group

Description:

amblyopia in patching group will receive patching treatment.

Treatment:

Device: Patching group