Augmenting Atropine Treatment for Amblyopia in Children 3 to < 8 Years Old
Condition: Amblyopia
MeSH terms: Amblyopia
Intervention: Atropine; Plano lens; Atropine
Intervention description: Weekend atropine 1%; plano lens over the sound eye; Weekend atropine 1%
Intervention MeSH terms: Atropine
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 73.0
Sex: All
Minimum age: 3 Years
Maximum age: 7 Years
Healthy volunteers: No
Keywords: Amblyopia; atropine; Plano lens

Summary:

      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.
    

Eligibility criteria:

        Inclusion Criteria:

        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.

        Exclusion Criteria:

          -  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