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

Amblyopia, Anisometropic Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02970708
• Other study ID #: YFZX2016001
• Status: Not yet recruiting
• Phase: N/A
• First received: November 17, 2016
• Last updated: November 17, 2016
• Start date: January 2017
• Est. completion date: January 2020

Study information

• Verified date: November 2016
• Source: Shanghai Eye Disease Prevention and Treatment Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 176
• Est. completion date: January 2020
• Est. primary completion date: June 2017
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 4 Years to 13 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Amblyopia
• Amblyopia, Anisometropic

Intervention

Device:
• EFG group
88 anisometropic amblyopia will be recruited to receive Eyetronix Flicker Glasses treatment.
• Patching group
88 anisometropic amblyopia will be recruited to receive patching treatment.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Shanghai Eye Disease Prevention and Treatment Center

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	best corrected visual acuity	have an improvement of best corrected visual acuity in the amblyopic eyes	6 months	No
Secondary	stereocuity	have an improvement of stereocuity in the amblyopic eyes	6 months	No
Secondary	contrast sensitivity function	have an improvement of contrast sensitivity in the amblyopic eyes	6 months	No
Secondary	visual evoked potential	P100 latency decrease and N75-P100 amplitude increase in the amblyopic eye.	6 months	No
Secondary	functional MRI	the visual cortex activity have an improvement	6 months	No
Secondary	best corrected visual acuity	have an improvement of best corrected visual acuity in the amblyopic eyes	a year and a half	No