NCT03080285

Efficacy of Over-glasses Patch Treatment for Amblyopia in Children : OPTA Study

Efficacy of Over-glasses Patch Treatment for Amblyopia in Children :OPTA Study, A Prospective Randomized Clinical Trial

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 107 (actual)
• Sponsor: Pusan National University Hospital · Academic / Other
• Sex: All
• Age: 3 Years – 7 Years
• Healthy volunteers: Not accepted

Summary

This is a study to investigate efficacy of over-glasses patch treatment for amblyopic children using visual function improvement and Amblyopia Treatment Index (ATI) changes.

Detailed description

In a randomized multi-center controlled clinical trial, children younger than 7 years with moderate amblyopia (visual acuity in the range of 20/40 to 20/100) would be included to receive treatment with either a conventional patch or an over-glasses patch. The patients will be prescribed 2 hours of patching per day for the sound eye. Best-corrected visual acuity (BCVA) and stereopsis will be investigated and ATI questionnaires be collected from parents at 5 weeks and 17 weeks after the initiation of treatment.

Conditions

• Amblyopia

Interventions

Type	Name	Description
DEVICE	over-glasses patch	Over-glasses patch (Tomato Eye Patch, Tomato Inc., Busan, South Korea) is applied to the patients. They were prescribed 2 hours of patching per day for the sound eye.
DEVICE	Conventional patch	Conventional patch (Opticlude Eye Patch, 3M, Maplewood, MN, USA) is applied to the patients. They were prescribed 2 hours of patching per day for the sound eye.

Timeline

• Start date: 2014-07-01
• Primary completion: 2016-05-01
• Completion: 2016-05-01
• First posted: 2017-03-15
• Last updated: 2017-03-15