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

NCT ID: NCT02970708

Last Updated: 2016-11-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

176 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-01-31

Study Completion Date

2020-01-31

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.

Conditions

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Amblyopia, Anisometropic

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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EFG group

amblyopia in EFG group will receive Eyetronix Flicker Glassess treatment.

Group Type EXPERIMENTAL

EFG group

Intervention Type DEVICE

88 anisometropic amblyopia will be recruited to receive Eyetronix Flicker Glasses treatment.

Patching group

amblyopia in patching group will receive patching treatment.

Group Type ACTIVE_COMPARATOR

Patching group

Intervention Type DEVICE

88 anisometropic amblyopia will be recruited to receive patching treatment.

Interventions

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EFG group

88 anisometropic amblyopia will be recruited to receive Eyetronix Flicker Glasses treatment.

Intervention Type DEVICE

Patching group

88 anisometropic amblyopia will be recruited to receive patching treatment.

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

4 Years

Maximum Eligible Age

13 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Shanghai Eye Disease Prevention and Treatment Center

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Other Identifiers

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YFZX2016001

Identifier Type: -

Identifier Source: org_study_id