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

• Sponsor: Shanghai Eye Disease Prevention and Treatment Center (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT02970708
• Collaborator: (none)
• Enrollment: 176
• Arms: 2
• Duration (Months): 36

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Amblyopia, Anisometropic	Device: EFG group; Device: Patching group	N/A

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 Design

• Study Type: Interventional
• Anticipated Enrollment: 176 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Efficacy and Safety of Eyetronix Flicker Glasses to the Treatment of Anisometropic Amblyopia in Chinese Children
• Study Start Date: Jan 1, 2017
• Anticipated Primary Completion Date: Jun 1, 2017
• Anticipated Study Completion Date: Jan 1, 2020

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

1. best corrected visual acuity [6 months]

   have an improvement of best corrected visual acuity in the amblyopic eyes

Secondary Outcome Measures

1. stereocuity [6 months]

   have an improvement of stereocuity in the amblyopic eyes

2. contrast sensitivity function [6 months]

   have an improvement of contrast sensitivity in the amblyopic eyes

3. visual evoked potential [6 months]

   P100 latency decrease and N75-P100 amplitude increase in the amblyopic eye.

4. functional MRI [6 months]

   the visual cortex activity have an improvement

5. best corrected visual acuity [a year and a half]

   have an improvement of best corrected visual acuity in the amblyopic eyes

Eligibility Criteria

Criteria

• Ages Eligible for Study: 4 Years to 13 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Shanghai Eye Disease Prevention and Treatment Center

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Shanghai Eye Disease Prevention and Treatment Center
• ClinicalTrials.gov Identifier: NCT02970708
• Other Study ID Numbers: YFZX2016001
• First Posted: Nov 22, 2016
• Last Update Posted: Nov 22, 2016
• Last Verified: Nov 1, 2016

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Additional relevant MeSH terms: Amblyopia

Study Results

No Results Posted as of Nov 22, 2016