NCT00094692

Brief Summary

The goals of this study are:

  • To determine the response rate of treatment of amblyopia in 7 to \<18 year olds.
  • To determine the frequency of recurrence of amblyopia in 7 to \<18 year olds after discontinuation of amblyopia treatment.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
507

participants targeted

Target at P50-P75 for phase_3

Timeline
Completed

Started Oct 2002

Typical duration for phase_3

Geographic Reach
1 country

3 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

October 1, 2002

Completed
2.1 years until next milestone

First Submitted

Initial submission to the registry

October 21, 2004

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 22, 2004

Completed
1.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2005

Completed
Last Updated

March 24, 2010

Status Verified

May 1, 2007

First QC Date

October 21, 2004

Last Update Submit

March 23, 2010

Conditions

Amblyopia

Keywords

AmblyopiaPatchingSpectacles

Outcome Measures

Primary Outcomes (1)

  • Visual acuity improvement

Interventions

Eye patchDEVICE
spectaclesDEVICE
atropineDRUG

Eligibility Criteria

Age7 Years - 17 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Patients must be aged 7 to \<18 years and have amblyopia associated with strabismus, anisometropia, or both.
  • Visual acuity in the amblyopic eye must be 20/40 to 20/400 inclusive and visual acuity in the sound eye must be 20/25 or better.

You may not qualify if:

  • Patients must not have received amblyopia treatment (other than spectacles) in the past month or more than one month of amblyopia treatment in the last 6 months.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Wilmer Eye Institute

Baltimore, Maryland, 21287-9028, United States

Location

Pennsylvania College of Optometry

Philadelphia, Pennsylvania, 19141, United States

Location

Children's Hospital of Pittsburgh

Pittsburgh, Pennsylvania, 15213, United States

Location

Related Publications (5)

  • Pediatric Eye Disease Investigator Group. A prospective, pilot study of treatment of amblyopia in children 10 to <18 years old. Am J Ophthalmol. 2004 Mar;137(3):581-3. doi: 10.1016/j.ajo.2003.08.043.

    PMID: 15013894BACKGROUND

  • 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: 15824215BACKGROUND

  • Hertle RW, Scheiman MM, Beck RW, Chandler DL, Bacal DA, Birch E, Chu RH, Holmes JM, Klimek DL, Lee KA, Repka MX, Weakley DR Jr; Pediatric Eye Disease Investigator Group. Stability of visual acuity improvement following discontinuation of amblyopia treatment in children aged 7 to 12 years. Arch Ophthalmol. 2007 May;125(5):655-9. doi: 10.1001/archopht.125.5.655.

    PMID: 17502505BACKGROUND

  • 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

Interventions

EyeglassesAtropine

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

LensesOptical DevicesEquipment and SuppliesAtropine DerivativesTropanesAzabicyclo CompoundsAza CompoundsOrganic ChemicalsBelladonna AlkaloidsSolanaceous AlkaloidsAlkaloidsHeterocyclic CompoundsBridged Bicyclo Compounds, HeterocyclicHeterocyclic Compounds, Bridged-Ring

Study Officials

  • Richard W. Hertle, M.D.

    University of Pittsburgh

    STUDY CHAIR

  • Mitchell M. Scheiman, O.D.

    Pennsylvania College of Optometry

    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

October 21, 2004

First Posted

October 22, 2004

Study Start

October 1, 2002

Study Completion

December 1, 2005

Last Updated

March 24, 2010

Record last verified: 2007-05

Locations

US(3)