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

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

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

Study Overview

• Status: Unknown
• Conditions: Amblyopia, Anisometropic
• Intervention / Treatment: Device: EFG group; Device: Patching group

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 Type: Interventional
• Enrollment (Anticipated): 176
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 4 years to 13 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Shanghai Eye Disease Prevention and Treatment Center

Study record dates

Study Major Dates

• Study Start: January 1, 2017
• Primary Completion (Anticipated): June 1, 2017
• Study Completion (Anticipated): January 1, 2020

Study Registration Dates

• First Submitted: November 17, 2016
• First Submitted That Met QC Criteria: November 17, 2016
• First Posted (Estimate): November 22, 2016

Study Record Updates

• Last Update Posted (Estimate): November 22, 2016
• Last Update Submitted That Met QC Criteria: November 17, 2016
• Last Verified: November 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Eye Diseases; Neurologic Manifestations; Sensation Disorders; Vision Disorders; Amblyopia
• Other Study ID Numbers: YFZX2016001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided