NCT02970708

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 176 (estimated)
• Sponsor: Shanghai Eye Disease Prevention and Treatment Center · Academic / Other
• Sex: All
• Age: 4 Years – 13 Years
• Healthy volunteers: Not accepted

Summary

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

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.

Conditions

• Amblyopia, Anisometropic

Interventions

Type	Name	Description
DEVICE	EFG group	88 anisometropic amblyopia will be recruited to receive Eyetronix Flicker Glasses treatment.
DEVICE	Patching group	88 anisometropic amblyopia will be recruited to receive patching treatment.

Timeline

• Start date: 2017-01-01
• Primary completion: 2017-06-01
• Completion: 2020-01-01
• First posted: 2016-11-22
• Last updated: 2016-11-22