NCT00094614

Brief Summary

The goals of this study are:

  • To compare the visual acuity outcome in the amblyopic eye after 17 weeks of daily use of atropine versus weekend-only use of atropine.
  • To compare the proportion of patients achieving a complete treatment response (defined as amblyopic eye acuity \>20/25 or equal to that of the sound eye in the absence of a reduction in the sound eye acuity from baseline) with daily atropine versus weekend-only atropine.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
168

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Jun 2002

Shorter than P25 for phase_4

Geographic Reach
1 country

1 active site

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

June 1, 2002

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2003

Completed
1.6 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
Last Updated

March 25, 2010

Status Verified

April 1, 2006

First QC Date

October 21, 2004

Last Update Submit

March 24, 2010

Conditions

Amblyopia

Outcome Measures

Primary Outcomes (1)

  • Visual acuity

Interventions

AtropineDRUG

Eligibility Criteria

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

You may qualify if:

  • Age \< 7 years
  • Able to measure surrounded single optotype visual acuity using the ATS single-surround HOTV protocol (this will in effect exclude all patients \<2 years old and many \<3 years old)
  • Amblyopia associated with strabismus, anisometropia, or both
  • If anisometropia is present (as per protocol definition), refractive error corrected with spectacles for a minimum of 4 weeks
  • Visual acuity in the amblyopic eye \< 20/40 and \>20/80
  • Visual acuity in the sound eye \> 20/40 and inter-eye acuity difference \>3 logMAR lines

You may not qualify if:

  • Amblyopia treatment (other than spectacles) in the past month and no more than one month of amblyopia treatment in the past 6 months
  • Myopia more than a spherical equivalent of -6.00 D in the amblyopic eye
  • Myopia more than a spherical equivalent of -0.50 D in the sound eye

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Wilmer Eye Institute

Baltimore, Maryland, 21287-9028, United States

Location

Related Publications (4)

  • Repka MX, Cotter SA, Beck RW, Kraker RT, Birch EE, Everett DF, Hertle RW, Holmes JM, Quinn GE, Sala NA, Scheiman MM, Stager DR Sr, Wallace DK; Pediatric Eye Disease Investigator Group. A randomized trial of atropine regimens for treatment of moderate amblyopia in children. Ophthalmology. 2004 Nov;111(11):2076-85. doi: 10.1016/j.ophtha.2004.04.032.

    PMID: 15522375RESULT

  • 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

  • Christoff A, Repka MX, Kaminski BM, Holmes JM; Pediatric Eye Disease Investigator Group. Distance versus near visual acuity in amblyopia. J AAPOS. 2011 Aug;15(4):342-4. doi: 10.1016/j.jaapos.2011.05.004.

    PMID: 21907115DERIVED

  • 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

Atropine

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Atropine DerivativesTropanesAzabicyclo CompoundsAza CompoundsOrganic ChemicalsBelladonna AlkaloidsSolanaceous AlkaloidsAlkaloidsHeterocyclic CompoundsBridged Bicyclo Compounds, HeterocyclicHeterocyclic Compounds, Bridged-Ring

Study Officials

  • Michael X Repka, MD

    Wilmer Eye Institute

    STUDY CHAIR

  • Jonathan M Holmes, MD

    Mayo Clinic Department of Ophthalmology

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 4
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

June 1, 2002

Study Completion

April 1, 2003

Last Updated

March 25, 2010

Record last verified: 2006-04

Locations

US(1)