Tackling Unresolved Myopia Control Issues
BY JASON J. NICHOLS, OD, MPH, PHD, FAAO
There is absolutely no doubt that myopia control using optical interventions is one of the hottest topics today in the eyecare industry. This is particularly true in the contact lens space, as certain multifocal and orthokeratology designs are proving to have a substantial impact on slowing the progression of myopia in children—and we anticipate even more data to be forthcoming. It’s remarkable that nearly one-quarter of U.S. practitioners reported actively using contact lenses for myopia control in their practices (see our annual report titled “Contact Lenses 2015” in the January 2016 issue).
All of this said, there are still many unresolved issues that relate to myopia control, and these undoubtedly are impacting the regulatory process regarding the approval or clearance of medical devices with a myopia control indication or claim. Although there are many questions, one that needs adequate consensus is how much of an effect is truly considered clinically relevant? Twenty-five percent? Fifty percent? We, as a community, need to guide this discussion with a comprehensive evidence base.
A second significant question relates to the care and aftercare of patients wearing contact lenses for myopia control: What follow-up care is necessary? How frequent should it be? What should be assessed (e.g., axial length)? Similar to the issue of clinically relevant effect size, we as a community should be guiding that discussion both with evidence and clinical knowledge.
There is also the issue of risk, particularly as it relates to children and the wear of contact lenses. While that is of utmost importance, I think it is important to realize that millions of children wear contact lenses around the globe. And, to my knowledge, I am not aware of any scientific evidence showing that children are more at risk for complications or infection while wearing contact lenses than adults are; in fact, lens wearers in their later teens and early 20s have been shown to be more at risk.
Later this year, the U.S. Food and Drug Administration (FDA) plans to hold a meeting open to the public on myopia control (http://www.cfom.info/meetings/myopia). The meeting will take place Sept. 30, 2016 at the FDA’s White Oak Campus in Silver Springs, MD. I think this is a critical meeting that will certainly impact the discussions on myopia control as we go forward in the future. Stay tuned for more detailed information from Contact Lens Spectrum following this meeting.