NCT00091923

Brief Summary

The objectives of the Spectacle Phase are:

  • In all other patients, to achieve maximal improvement with spectacle correction prior to entering the randomized trial. The objectives of the Randomized Trial are:
  • To determine whether 5 weeks of patching treatment (2 hours of patching per day of the sound eye combined with at least one concurrent hour of near activities), compared with a control group (using spectacle correction only), improves visual acuity in patients with moderate to severe amblyopia (20/40 to 20/400).
  • To determine the maximal improvement and time course of improvement with this patching treatment regimen.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
268

participants targeted

Target at P50-P75 for phase_3

Timeline
Completed

Started Feb 2004

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, 2004

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

September 20, 2004

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 22, 2004

Completed
1.2 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

September 1, 2009

First QC Date

September 20, 2004

Last Update Submit

March 23, 2010

Conditions

Amblyopia

Outcome Measures

Primary Outcomes (1)

  • maximal improvement in visual acuity

Interventions

Eye patchDEVICE
SpectaclesDEVICE

Eligibility Criteria

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

You may qualify if:

  • Age 3 to \<7 years
  • Able to perform visual acuity using the ATS single-surround HOTV protocol
  • Amblyopia associated with strabismus (comitant or incomitant), anisometropia, or both
  • Visual acuity in the amblyopic eye 20/40 to 20/400 inclusive
  • Visual acuity in the sound eye \>20/40
  • Inter-eye acuity difference \>3 logMAR lines
  • Cycloplegic refraction and ocular examination within 2 months prior to enrollment

You may not qualify if:

  • No amblyopia treatment (other than spectacles) in the past month and no more than one month of amblyopia treatment in the past 6 months
  • No current vision therapy or orthoptics
  • No ocular cause for reduced visual acuity
  • No myopia more than a spherical equivalent of -6.00 D
  • No prior intraocular or refractive surgery
  • No known skin reactions to patch or bandage adhesives

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Southern California College of Optometry

Fullerton, California, 92831, United States

Location

Duke University Eye Center

Durham, North Carolina, 27710, United States

Location

Related Publications (4)

  • Cotter SA; Pediatric Eye Disease Investigator Group; Edwards AR, Wallace DK, Beck RW, Arnold RW, Astle WF, Barnhardt CN, Birch EE, Donahue SP, Everett DF, Felius J, Holmes JM, Kraker RT, Melia M, Repka MX, Sala NA, Silbert DI, Weise KK. Treatment of anisometropic amblyopia in children with refractive correction. Ophthalmology. 2006 Jun;113(6):895-903. doi: 10.1016/j.ophtha.2006.01.068.

    PMID: 16751032RESULT

  • Wallace DK; Pediatric Eye Disease Investigator Group; Edwards AR, Cotter SA, Beck RW, Arnold RW, Astle WF, Barnhardt CN, Birch EE, Donahue SP, Everett DF, Felius J, Holmes JM, Kraker RT, Melia M, Repka MX, Sala NA, Silbert DI, Weise KK. A randomized trial to evaluate 2 hours of daily patching for strabismic and anisometropic amblyopia in children. Ophthalmology. 2006 Jun;113(6):904-12. doi: 10.1016/j.ophtha.2006.01.069.

    PMID: 16751033RESULT

  • 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

Related Links

MeSH Terms

Conditions

Amblyopia

Interventions

Eyeglasses

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 Supplies

Study Officials

  • David K. Wallace, M.D.

    Duke University Eye Center

    STUDY CHAIR

  • Susan A. Cotter, O.D.

    Southern California College of Optometry at Marshall B. Ketchum University

    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

September 20, 2004

First Posted

September 22, 2004

Study Start

February 1, 2004

Study Completion

December 1, 2005

Last Updated

March 24, 2010

Record last verified: 2009-09

Locations

US(2)