Augmenting Atropine Treatment for Amblyopia in Children 3 to < 8 Years Old

Completed · Phase 3

Conditions studied: Amblyopia

In brief

This study is designed to evaluate the effectiveness of adding a plano lens to weekend atropine after visual acuity has stabilized with weekend atropine but amblyopia is still present. Children ages 3 to \<8 years with visual acuity of 20/50 to 20/400 in the amblyopic eye will be enrolled in a run-in phase with weekend atropine until no improvement, followed by randomization of eligible patients to weekend atropine treatment with a plano lens over the sound eye versus without a plano lens over the sound eye. The primary objective is to determine if adding a plano lens to weekend atropine will improve visual acuity in patients with amblyopia still present after visual acuity has stabilized with initial treatment.

Key facts

Study ID

NCT00944710

Run by

Jaeb Center for Health Research

People needed

73

Starts

2009-08-01

Expected to finish

2013-11-01

Last updated by the study team

2019-03-06

Who can join

Age: 3 and older, up to 7. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Major Eligibility Criteria for Run-in Phase
• Age 3 to < 8 years
• Amblyopia associated with strabismus, anisometropia, or both
• Visual acuity in the amblyopic eye between 20/50 and 20/400 inclusive
• Visual acuity in the sound eye 20/32 or better and inter-eye acuity difference >3 logMAR lines
• Amblyopia treatment within the past 6 months subject to the following stipulations:
• No more than 6 weeks of any amblyopia treatment other than spectacles (except for patients being treated with atropine who are entering the study on treatment)
• No simultaneous treatment with patching and atropine
• No use of atropine in combination with the sound eye spectacle lens reduced by more than 1.50 D
• Maximum level of treatment within the past 6 months:
• Patching: up to 2 hours daily
• Atropine: up to once daily
• Wearing spectacles with optimal correction (if amblyopic eye acuity is 20/80 or better, then VA must be stable in glasses; if amblyopic eye acuity is 20/100 or worse, then spectacles and atropine can be initiated simultaneously).
• Hypermetropia and spectacle correction in sound eye of +1.50 D or more
• Eligibility Criteria for Randomization:
• Amblyopic eye acuity of 20/40 to 20/160 with an inter-ocular difference of >2 lines, or amblyopic eye acuity of 20/32 with 3 lines of IOD.
• Compliance with weekend atropine treatment based on investigator judgment.

You may not qualify if…

• Currently using vision therapy or orthoptics
• Ocular cause for reduced visual acuity (nystagmus per se does not exclude the patient if the above visual acuity criteria are met)
• Prior intraocular or refractive surgery
• Known allergy to atropine or other cycloplegic drugs
• Down Syndrome present

Where it is running

• Southern California College of Optometry — Fullerton, California, United States
• Duke University Eye Center — Durham, North Carolina, United States

Full record on ClinicalTrials.gov

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