November 14, 2016
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Research community seeks consistency in myopia control trials

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Myopia control. It is certainly on everyone’s mind — patients included — and for good reason. With more than 40% of American adults manifesting myopia and a prevalence nearly double that in certain Asian nations, myopia has become a significant public health issue.

The shear cost of correcting myopia, be it spectacles, contact lenses or laser vision correction, is staggering. Add its impact on quality of life as well as its influence on a variety of related ocular pathologies, and it is clear why myopia is such a concern. Perhaps the greatest concern is for the myopic child.

Mirroring our adult population, the prevalence of myopia in American high school students has nearly doubled over the past 30 years. Whether the result of genetics, educational demands, digital device use or lack of time outdoors, myopia is impacting an increasing number of children and at an earlier age. With earlier manifestation comes more rapid progression and an inevitable trend toward a greater prevalence of high myopia with each subsequent generation.

Among those most concerned about childhood myopia are the parents. Today’s parents not only want their child seeing well now, but they also want to know what can be done to slow the progression of myopia. They are often engaged, concerned and intelligent individuals who have researched myopia progression and who look to us for answers. In short, they are putting their child’s future in our hands. Unfortunately, given the complexity of myopia, helping parents chart a course for their child is no easy task.

We can certainly impress parents with an array of potential interventions – offering bifocal eyeglasses, annular design multifocal soft lenses, overnight wear of reverse geometry lenses, low dose atropine and increased time outdoors as strategies for slowing myopia progression. The challenge lies in prioritizing these options, especially given that we lack definitive answers for each strategy.

For instance, for what small subset of the population are bifocal spectacles viable? Are the effects of annular design soft lenses sustainable? Is there a measurable risk in wearing orthokeratology lenses overnight? Do the side effects of atropine outweigh its benefits? And, just how much time outdoors is optimal? Further complicating our decision making is the challenge of defining just what constitutes a clinically significant improvement, especially given that rates of progression vary from child to child ... and year to year.

Michael D. DePaolis

The good news is that even though myopia control is a relatively young discipline, there is an impressive base of research upon which to formulate our treatment initiatives. While many of these clinical trials have been well conducted, myopia control research has been criticized for its lack of consistency. Patient selection criteria, clinical trials design and outcomes endpoints, for instance, have varied widely.

To address this issue, the research community is attempting to reach a model consensus for future studies. This was the impetus behind the recent “Controlling the progression of myopia: Contact lenses and future medical devices” workshop on Sept. 30 at the FDA, in which representatives from organized optometry, ophthalmology and the FDA drafted guidelines for future clinical trials.

In this month’s Primary Care Optometry News, Editor-in-Chief Nancy Hemphill provides an exceptional overview of the day’s proceedings. I encourage you to read Nancy’s article, “Experts debate reach consensus on parameters for myopia control trials.” Not only will it give you a better sense of where the field is moving, it will provide much needed answers to the questions of today – especially those asked by patients and their parents.