CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 233 enrolled
Drug / intervention
Atropine +2 moredrug
Likely dose
Atropine 1% each weekend day in the sound eye; Patching 2 hours per day; Near visual activities at least one hour per dayAI-extracted
Key inclusion· 6
  • Age 7 to 12 years old (inclusive)
  • Amblyopia associated with strabismus, anisometropia, or both
  • Visual acuity in the amblyopic eye 19 to 71 letters on E-ETDRS (20/40 to 20/400 inclusive)
  • Visual acuity in the sound eye 79 letters or better on E-ETDRS (20/25 or better)
Key exclusion· 2
  • Amblyopia treatment (other than spectacles) in the last 6 months
  • Myopia greater than −0.25D spherical equivalent in either eye

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00315328
NCT00315328Phase 3Completed

A Randomized Trial Comparing Patching Versus Atropine for Amblyopia in 7 to < 13 Year Olds

Jaeb Center for Health Research·interventional·Posted Apr 18, 2006·Updated Jun 24, 2016

In Brief

A Phase 3 clinical trial evaluating Atropine, Patching, and 1 other intervention for Amblyopia. Completed, enrolled 233 participants across 2 sites.

Detailed Summary

The purpose of this study is: * To compare the effectiveness of weekend atropine plus near activities and daily patching plus near activities for moderate amblyopia (20/40 to 20/100) and severe amblyopia (20/125 to 20/400) in improving vision in the amblyopic eye of 7 to \<13 year olds. * To determine the maximum improvement in vision of the amblyopic eye with each treatment. * To determine whether amblyopia is associated with structural abnormalities of optic nerve fiber layer.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAmblyopia
CountriesUnited States

Timeline

Phase 3CompletedFinished
20052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedApr 18, 2006
Enrollment StartAug 1, 2005
Primary CompletionDec 1, 2007
Study CompletionJan 1, 2008
TodayJul 2, 2026
Enrollment to primary: 2.3 yearsPosted 20.2 years ago

Interventions

Atropinedrug

Atropine 1% each weekend day in the sound eye

Patchingdevice

Patching 2 hours per day

Near activitiesprocedure

near visual activities for at least one hour per day