The Contact Lens and Myopia Progression (CLAMP) Study
Condition: Myopia
MeSH terms: Myopia
Study type: Observational

Summary: 
      To examine the effects of rigid gas permeable contact lenses on the progression of myopia
      (nearsightedness) in children

      To determine what changes in the eyes cause certain eyes to progress in nearsightedness more
      slowly
    

Detailed description: 
      Rigid gas permeable (RGP) contact lenses provide clear, comfortable vision with relatively
      few ocular health risks and are a standard management option for correcting nearsightedness.
      While RGP contact lenses are used to correct myopic refractive error, they may also slow the
      progression of myopia. A definitive study that could provide guidance regarding the effects
      of rigid gas permeable contact lenses on myopia (nearsightedness) progression may define the
      standard of care for slowing the progression of myopia in young children.

      An eye care practitioner first reported that hard contact lenses may slow or stop the
      progression of nearsightedness in 1956. Other anecdotal clinical reports with similar results
      soon followed. Previous review papers have suggested that rigid contact lenses slow the
      progression of myopia in children, and several studies have attempted to prove this.

      Two studies in the past twenty years have shown that rigid gas permeable contact lenses slow
      the progression of nearsightedness in children, however both studies failed to provide proper
      attention to many important variables. While these earlier works produced intriguing results
      for scientists and clinicians, they contain many problems that challenge the significance of
      the studies findings. The faults of the previous studies can be summarized in four
      categories: 1) high losses to follow-up, 2) inadequate control group, 3) incomplete ocular
      component measurements, and 4) inadequate or poorly selected entry criteria.

      Positive results in previous studies also failed to exclude alternate possibilities which may
      explain why rigid gas permeable contact lenses may slow the progression of myopia. For
      example, the studies found that rigid contact lenses slow the progression of myopia and that
      corneal flattening accounts for some of the treatment effect, but none of the studies was
      able to definitively answer other mechanisms that may slow myopia advancement. A need for a
      controlled study of rigid contact lenses which measures all of the components that may affect
      myopia progression still exists. The CLAMP Study examines all of these components and
      addresses the problems encountered in previous studies.

      The CLAMP Study uses a run-in period to enroll only children who are able to adapt to rigid
      contact lens wear into the study. This decreases the number of children who drop-out of the
      study because they cannot adapt to rigid contact lens wear. Once children show that they are
      able to wear rigid contact lenses, they are enrolled in the study and randomly assigned to
      wear rigid gas permeable contact lenses or soft contact lenses. Both groups are then examined
      each year for three years to determine which group progresses the most in nearsightedness.

      Annual examinations include assessment of the children's ability to focus their eyes, their
      eye glass prescription, the length of their eyes, detailed maps of the shape and thickness of
      their corneas (the clear window on the front of the eye), the shape of their eyes, and the
      curvature of the lens inside the eye. Their eye glass prescription is determined when the
      children's eyes are dilated. We examined 222 children for eligibility. Out of the 222
      children, 148 were eligible to participate in the run-in period. Of the 148 eligible
      children, 116 (78.5%) were able to adapt to rigid gas permeable contact lens wear. All of the
      children were examined at The Ohio State University College of Optometry.