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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

107 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-07-31

Study Completion Date

2016-05-31

Brief Summary

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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.

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Detailed Description

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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

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Amblyopia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Conventional patch

The patients were prescribed 2 hours of patching per day for the sound eye and the spectacles were to be worn full-time.

Conventional patch is occlusion treatment sticker (Opticlude Eye Patch, 3M, Maplewood, MN, USA) with an adhesive material attached to the skin and serves to cover the eyes.

Group Type ACTIVE_COMPARATOR

Conventional patch

Intervention Type DEVICE

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.

over-glasses patch

the patients were prescribed 2 hours of patching per day for the sound eye and the spectacles were to be worn full-time.

Over-glasses patch (Tomato Eye Patch, Tomato Inc., Busan, South Korea) is made of fabric and covers the glasses, hence serves to cover the eyes.

Group Type EXPERIMENTAL

over-glasses patch

Intervention Type DEVICE

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.

Interventions

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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.

Intervention Type 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.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

1. moderate amblyopia (logMAR visual acuity in the amblyopic eye 0.3 to 0.7 inclusive)
2. logMAR visual acuity in the sound eye of 0.1 or better
3. intereye acuity difference of larger or equal to 0.3 of logMAR visual acuity
4. the presence of or a history of an amblyogenic factor meeting study-specified criteria for strabismus and/or anisometropia.

Exclusion Criteria

1. presence of an ocular cause for low vision
2. myopia greater than -6.0 diopters (D) spherical equivalent in either eye
3. prior intraocular or refractive surgery
4. treatment for amblyopia (other than spectacle correction) within the 6 months prior to the enrollment
5. Down syndrome

Minimum Eligible Age

3 Years

Maximum Eligible Age

7 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No