CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 240 enrolled
Drug / intervention
Atropine +1 moredrug
Likely dose
Atropine 1% once each weekend dayAI-extracted
Key inclusion· 6
  • ✓Age 3 to <7 years old
  • ✓Amblyopia associated with strabismus, anisometropia, or both
  • ✓Visual acuity in amblyopic eye between 20/40 and 20/400 inclusive
  • ✓Visual acuity in sound eye 20/40 or better
Key exclusion· 3
  • ✕Atropine treatment within 6 months of enrollment
  • ✕Any amblyopia treatment other than spectacle lenses within 1 month of enrollment
  • ✕No myopia in the amblyopic eye

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

Search/NCT00315302
NCT00315302Phase 3Completed
CompareCT.gov

A Randomized Trial Comparing Atropine to Atropine Plus a Plano Lens for the Sound Eye As Prescribed Treatments for Amblyopia in Children 3 to <7 Years Old

Jaeb Center for Health Research·interventional·Posted Apr 18, 2006·Updated Jul 19, 2016

In Brief

A Phase 3 clinical trial evaluating Atropine and Plano Lens for Amblyopia. Completed, enrolled 240 participants across 2 sites.

Detailed Summary

The purpose of the study is: * To compare the effectiveness and safety of weekend atropine augmented with a plano lens for the sound eye versus weekend atropine alone for moderate amblyopia (20/40 to 20/100) in children 3 to less than 7 years old. * To provide data on the response of severe amblyopia (20/125 to 20/400) to atropine treatment with and without a plano lens.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAmblyopia
CountriesUnited States
CollaboratorsNational Eye Institute (NEI)

Timeline

Phase 3CompletedFinished
20052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedApr 18, 2006
Enrollment StartFeb 1, 2005
Primary CompletionOct 1, 2007
Study CompletionJan 1, 2008
TodayJul 2, 2026
Enrollment to primary: 2.7 yearsPosted 20.2 years ago

Interventions

Atropinedrug

Atropine 1% once each weekend day

Plano Lensdevice

Plano lens for the sound eye