Bifocal & Atropine in Myopia (BAM) Study
Condition: Refractive Errors
MeSH terms: Refractive Errors
Study type: Interventional

Summary: 
      This study will test whether the combined treatment of 0.01% atropine and soft bifocal
      contact lens wear produces slower myopia progression and axial elongation compared to soft
      bifocal contact lenses alone in children ages 7 to 11 years old.
    

Detailed description: 
      Both atropine and soft bifocal contact lenses have been shown to slow myopia progression, and
      both can cause changes in choroidal thickness. But the relationship between these mechanisms
      is unclear. The central hypothesis to be tested in the BAM Study is that atropine and soft
      bifocal contact lenses each exert their anti-progression actions through a common pathway
      that involves the choroid. If this is correct, then adding atropine treatment to soft bifocal
      contact lens wear will lead to a more effective slowing of myopia progression than
      prescribing soft bifocal contact lenses alone due to the additive effects in the common
      pathway.

      The BAM Study is an ancillary study of an NIH sponsored multi-center, randomized clinical
      trial, the Bifocal Lenses In Nearsighted Kids (BLINK) Study (NIH: U10EY023208; NCT:
      NCT02255474). The BLINK Study compares myopia progression between subjects who wear single
      vision contact lenses and those wearing soft bifocal contact lenses. The BAM Study enrolls an
      additional 49 subjects that are age-matched with the participants who are wearing +2.50D add
      soft bifocal contact lenses in the BLINK Study. The subjects in the BAM Study wear +2.50D add
      soft bifocal contact lenses in combination with daily administration of one drop of 0.01%
      atropine in each eye for three years. The rates of myopia progression and axial elongation
      will be compared to the rates in participants who are receiving treatment with +2.50D add
      soft bifocal contact lenses alone in the BLINK Study.

      Two specific aims will be addressed: Aim 1: To test whether the combined treatment of 0.01%
      atropine and soft bifocal contact lens wear produces slower myopia progression and axial
      elongation compared to soft bifocal contact lenses alone over 3 years. Aim 2: To test whether
      early changes in choroidal thickness can be used as predictors of long-term myopia
      progression / axial elongation. The results of this study will have significant implications
      for future studies to develop and test new therapeutic regimes that optimize the effect of
      myopia control through combined pharmacological and optical interventions. The outcomes will
      also aid in understanding the potential role of short-term changes of choroidal thickness in
      long- term regulation of myopia progression and ocular growth.
    

Intervention name(s): Multifocal D +2.50 add & 0.01% atropine
Intervention type(s): Combination Product
Intervention description(s): Biofinity Multifocal D +2.50 add is a monthly disposable contact lens commercially available from CooperVision; 0.01% atropine is low-dose atropine compounded by local pharmacy.
Intervention MeSH terms: Atropine
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment