NCT03080285

Brief 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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
107

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jul 2014

Typical duration for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2014

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2016

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

March 9, 2017

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 15, 2017

Completed
Last Updated

March 15, 2017

Status Verified

March 1, 2017

Enrollment Period

1.8 years

First QC Date

March 9, 2017

Last Update Submit

March 14, 2017

Conditions

Amblyopia

Outcome Measures

Primary Outcomes (1)

  • Changes in visual acuity (logMAR)

    changes in best- corrected visual acuity between before treatment and after 17 weeks. Visual acuity is assessed using the Snellen chart. logMAR visual acuity ranges 0.0 to 3.0. logMAR visual acuity of 0.0 corresponds to 20/20. Lower scores represents better functioning.

    17 weeks

Secondary Outcomes (3)

  • amblyopia treatment index

    17 weeks

  • the best corrected visual acuity

    17 weeks

  • change of binocularity

    17 weeks

Study Arms (2)

Conventional patch

ACTIVE COMPARATOR

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.

Device: Conventional patch

over-glasses patch

EXPERIMENTAL

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.

Device: over-glasses patch

Interventions

over-glasses patchDEVICE

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.

over-glasses patch
Conventional patchDEVICE

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.

Conventional patch

Eligibility Criteria

Age3 Years - 7 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (3)

  • Scheiman MM, Hertle RW, Beck RW, Edwards AR, Birch E, Cotter SA, Crouch ER Jr, Cruz OA, Davitt BV, Donahue S, Holmes JM, Lyon DW, Repka MX, Sala NA, Silbert DI, Suh DW, Tamkins SM; Pediatric Eye Disease Investigator Group. Randomized trial of treatment of amblyopia in children aged 7 to 17 years. Arch Ophthalmol. 2005 Apr;123(4):437-47. doi: 10.1001/archopht.123.4.437.

    PMID: 15824215RESULT

  • Flynn JT, Schiffman J, Feuer W, Corona A. The therapy of amblyopia: an analysis of the results of amblyopia therapy utilizing the pooled data of published studies. Trans Am Ophthalmol Soc. 1998;96:431-50; discussion 450-3.

    PMID: 10360300RESULT

  • Wallace MP, Stewart CE, Moseley MJ, Stephens DA, Fielder AR; Monitored Occlusion Treatment Amblyopia Study (MOTAS) Cooperatives; Randomized Occlusion Treatment Amblyopia Study (ROTAS) Cooperatives. Compliance with occlusion therapy for childhood amblyopia. Invest Ophthalmol Vis Sci. 2013 Sep 17;54(9):6158-66. doi: 10.1167/iovs.13-11861.

    PMID: 23882695RESULT

MeSH Terms

Conditions

Amblyopia

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System DiseasesVision DisordersSensation DisordersNeurologic ManifestationsEye DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Hee young Choi, MD, PhD

    Pusan National University hospotal

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

March 9, 2017

First Posted

March 15, 2017

Study Start

July 1, 2014

Primary Completion

May 1, 2016

Study Completion

May 1, 2016

Last Updated

March 15, 2017

Record last verified: 2017-03

Data Sharing

IPD Sharing
Will not share