Correction of Myopia Evaluation Trial 2
Condition: Myopia
MeSH terms: Myopia
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of the study is to determine if progressive addition lenses (PALs) versus single
      vision lenses (SVLs) slow the progression of low myopia in children with poor accommodative
      responses (i.e., large accommodative lags) and near esophoria.
    

Detailed description: 
      Myopia is a significant public health problem that affects at least 34% of children in the
      United States and a much higher percentage in Asia. It is a predisposing factor for retinal
      detachment, myopic retinopathy, and glaucoma, thus contributing to loss of vision and
      blindness. As might be expected for such a prevalent condition, treatment costs are high. If
      interventions to retard myopia progression are successful, sight-threatening complications
      might be avoided and costs should be reduced.

      The study has been designed as a simple trial that, other than the type of lenses being
      determined through the randomization process and the addition of accommodation testing using
      an autorefractor, largely approximates standard clinical practice.

      Screening consists of non-cycloplegic procedures of subjective refraction, testing of
      oculomotor alignment, and testing of accommodative response using the Grand Seiko
      autorefractor.

      Patients who appear to be eligible for the randomized trial will be tested with their eyes
      dilated to determine whether refractive error in each eye is within the eligibility range for
      the randomized trial. Patients will be randomized to either progressive addition lenses
      (PALs) with a +2.00 D addition or to single vision lenses (SVLs). Children will have three
      years of follow up, with visits every 6 months.

      The primary outcome visit is timed 3 years from randomization, with the primary analysis
      being a comparison of the average change from baseline to 3 years in amount of myopia between
      children in the single-vision lens group and the children in the progressive-addition lens
      group. The primary outcome is change in spherical equivalent refractive error (SER) in
      diopters (D) as measured by cycloplegic autorefraction.

      A separate ancillary study nested within the screening process will collect data on two
      additional methods of measuring accommodation, Monocular Estimate Method (MEM) retinoscopy
      and Nott retinoscopy. The aim of the ancillary study to help determine whether a simple,
      effective measure exists that can be easily used by clinicians to identify children with
      reduced accommodative response who, if they have low myopia and esophoria, might benefit from
      the treatment with PALs.
    

Intervention name(s): Progressive Addition Lenses (PALs); Single Vision Lenses (SVLs)
Intervention type(s): Device; Device
Intervention description(s): Varilux Ellipse progressive addition lenses (PALs) with a +2.00 D addition; Single vision lenses
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: Myopia; Progressive Addition Lenses (PALs); Single Vision Lenses (SVLs); Accommodative lags; Near esophoria; Refractive error