NCT00315198

Brief Summary

Ths purpose of this study is to determine whether "near" activities enhance the effect of patching on visual acuity improvement in strabismic and anisometropic amblyopia when compared with "distance" activities in the treatment of moderate amblyopia and severe amblyopia in children 3 to \<7 years old.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
425

participants targeted

Target at P50-P75 for phase_3

Timeline
Completed

Started Feb 2005

Typical duration for phase_3

Geographic Reach
1 country

2 active sites

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

February 1, 2005

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

April 14, 2006

Completed
4 days until next milestone

First Posted

Study publicly available on registry

April 18, 2006

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2007

Completed
Last Updated

March 24, 2010

Status Verified

May 1, 2009

Enrollment Period

2.8 years

First QC Date

April 14, 2006

Last Update Submit

March 23, 2010

Conditions

Amblyopia

Keywords

amblyopiapatchingvisual activities

Outcome Measures

Primary Outcomes (1)

  • Visual acuity

    8 weeks

Secondary Outcomes (1)

  • Visual acuity

    17 weeks

Study Arms (2)

Near activities

ACTIVE COMPARATOR

2 hours of daily patching combined with near visual activities while patching

Device: Eye PatchProcedure: Near activities

Distance activities

ACTIVE COMPARATOR

2 hours of daily patching combined with distance visual activities while patching

Device: Eye PatchProcedure: Distance activities

Interventions

Eye PatchDEVICE

2 hours daily patching

Also known as: Coverlet, 3M Opticlude, Ortopad®
Distance activitiesNear activities
Near activitiesPROCEDURE

near visual activities while patching

Near activities
Distance activitiesPROCEDURE

distance visual activities while patching

Distance activities

Eligibility Criteria

Age3 Years - 6 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Patients must be 3 to less than 7 years old with amblyopia due to strabismus, anisometropia, or both.
  • Visual acuity in the amblyopic eye must be between 20/40 and 20/400 inclusive, visual acuity in the sound eye 20/40 or better and inter-eye acuity difference \> 3 logMAR lines.
  • Spectacles, if needed, must be worn for at least 16 weeks or until visual acuity documented to be stable.

You may not qualify if:

  • Prior amblyopia treatment other than spectacles in the past month.
  • More than one month of amblyopia treatment in the past 6 months.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Indiana University School of Optometry

Bloomington, Indiana, 47405, United States

Location

Mayo Clinic Department of Ophthalmology

Rochester, Minnesota, 55905, United States

Location

Related Publications (3)

  • Pediatric Eye Disease Investigator Group. A randomized trial of near versus distance activities while patching for amblyopia in children aged 3 to less than 7 years. Ophthalmology. 2008 Nov;115(11):2071-8. doi: 10.1016/j.ophtha.2008.06.031. Epub 2008 Sep 11.

    PMID: 18789533RESULT

  • Wallace DK, Lazar EL, Melia M, Birch EE, Holmes JM, Hopkins KB, Kraker RT, Kulp MT, Pang Y, Repka MX, Tamkins SM, Weise KK; Pediatric Eye Disease Investigator Group. Stereoacuity in children with anisometropic amblyopia. J AAPOS. 2011 Oct;15(5):455-61. doi: 10.1016/j.jaapos.2011.06.007.

    PMID: 22108357DERIVED

  • Repka M, Simons K, Kraker R; Pediatric Eye Disease Investigator Group. Laterality of amblyopia. Am J Ophthalmol. 2010 Aug;150(2):270-4. doi: 10.1016/j.ajo.2010.01.040. Epub 2010 May 8.

    PMID: 20451898DERIVED

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

  • Don Lyon, O.D.

    Indiana University

    STUDY CHAIR

  • Jonathan M. Holmes, M.D.

    Mayo Clinic Department of Ophthalmology

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

April 14, 2006

First Posted

April 18, 2006

Study Start

February 1, 2005

Primary Completion

December 1, 2007

Study Completion

December 1, 2007

Last Updated

March 24, 2010

Record last verified: 2009-05

Locations

US(2)