In 2005, a room full of us sat in Silver Spring while the FDA said out loud what we'd all been afraid to admit: myopia was becoming an epidemic, and we needed a way to stop it. Twenty years later, a low-dose atropine drug the FDA's own drug division just called "not meaningful" is heading back before a committee that could change how our entire profession practices. One ruling now stands between optometry and the preventative-care future it was built for.
Why OrthoK Never Made the Cut
The meeting was largely held to discuss paths forward for getting a myopia control indication approved. The parameters set forth were that any approved device should reduce in a meaningful fashion the incidence of high myopia, which was expected to affect over a billion humans by the year 2050 with all its associated disease complications. We arrived at a consensus of 50% reduction in axial length (AL) growth, which would have eliminated 75% of all high myopes if treatment could be applied soon enough. At that same meeting the FDA had also signaled that at least 30% reduction was meaningful. With every diopter of myopia we can eliminate, as an example, it reduces the likelihood of myopic macular degeneration (MMD), which is the number one cause of blindness worldwide, by 40%.(1)
It was decided at the meeting that a soft multifocal bifocal, which had just begun being utilized in studies, was the path forward. At the time we had that modality and OrthoK as the paths forward. Atropine in 2005 was being utilized in its 1% form in countries like Taiwan and sporadically across the US, but due to its high concentration and multiple induced symptoms such as photophobia and accommodative insufficiency, it wasn’t seriously considered despite a strong track record of AL suppression. The reason that OrthoK failed to make the cut was due to a lack of studies demonstrating yearly changes in refractive status and AL progression, which in the case of OrthoK would have involved yearly washouts of at least two weeks or more.(2)
I was involved in the Stabilizing Myopia By Accelerating Reshaping Technique (SMART) study during this time, which actually involved a two plus week washout period every year for patients wearing OrthoK lenses. The control group was made up of single vision soft contact lens wearers (SCLs). The problem we encountered with the study was with AL measurements which we used a modified Palm Pilot platform utilizing an Immersion A-Scan which proved problematic. Thus even though we demonstrated over 90% control of refractive change compared to single vision SCLs utilizing the Emerald design by Euclid, we had no AL measurements to back that up. The FDA wanted all of that data, and who could blame them. An approved myopia control designation, when it comes to OrthoK, awaits interested parties who will invest in a two year small controlled study demonstrating AL and refractive control with a two week washout for refractive status after each year of wear of the OrthoK lenses. We are awaiting this but not anticipating any company stepping up and doing it due to the high costs involved. There is no debate that OrthoK has been the most studied myopia control device and that it effectively controls both refractive change and axial length, yet it’s unlikely we’ll see a change in designation.(3)
"There is no debate that OrthoK has been the most studied myopia control device, yet it's unlikely we'll see a change in designation."
The Fight to Put “Myopia” in the Name
I founded the American Academy of Orthokeratology & Myopia Control in 2002. At that time of its founding it was known as the Orthokeratology Academy of America (OAA). The name was changed in my direction to include myopia and its control in its title. I was met with significant opposition from my board for many different reasons, including the idea that myopia itself was the bigger picture and it sure would be nice to control this epidemic at our door. I would love to tell you that at the time we were all on the same page on this, but it wouldn’t be an accurate assessment. Leaders in our field presently opposed the idea of OrthoK and myopia being associated together. They had rather hoped that we could keep OrthoK “pure” as it were. There was also not a consensus as to whether we should emphasize myopia in our title or education programs. Luckily for us, I had instructed our staff to dedicate a good part of our education program to myopia and its control before we ever debated the merits before the OAA board. The most recent changes by the present board are to emphasize myopia over OrthoK in their education and promotion, a natural evolution brought about more than two decades before.(4)
Management vs. Control: More Than Semantics
There has been a debate within our community on which term is more appropriate, and for the present, myopia management has seemed to win out even though I believe it causes more confusion. What exactly are we defining as management, because you can “manage” myopia very irresponsibly it seems with inappropriate methodology. Whereas control is unmistakable in exactly what that implies. In the end it’s just semantics after all.(5)
What the Atropine Skeptics Get Wrong
Low dose atropine (LDA) demonstrates in different studies anywhere from a 30%–60% control of myopia progression. I have heard criticisms of Sydnexis SYD 101, which is .01%, because it has demonstrated numbers on the lower end of that range. I listened to critiques of the massive Study of Atropine To Reduce Myopia Progression (STAR), which involved 847 children, because it didn’t measure AL. The FDA in setting the guidelines for LDA did not mandate AL measurements in its guidelines for an LDA study on myopia control. A criticism of this is that especially with Atropine, our patients can experience a “rebound effect” after treatment, and that AL measurements will document this more accurately. While it’s true in the case of Atropine 1%, it is extremely small, as in a .25D or less with LDA, and can be controlled entirely with tapering. Many of us in practice still don’t have a Biometer to take AL measurements but will confidently treat our patients with reasonable expectations of success. Yes, I would agree that AL measurements should be standard of care in myopia management/control, but certainly ECPs can function without it quite well. Refractive data alone combined with a wealth of LDA studies that do include AL measurements demonstrate it effectively controls AL.(6)(7)
The data itself includes the fact that SYD 101 effectively controls AL (71% reduction) in fast progressors, the same groups that the Low-Concentration Atropine For Myopia Progression (LAMP) utilized in their now eight year study. Many of us in practice still don’t have a Biometer to take AL measurements on but yet will confidently treat our patients with reasonable expectations of success. Yes, I would agree that AL measurements should be standard of care in myopia management/control, but ECPs can function without it.(7)
"SYD 101 effectively controls AL — a 71% reduction in the fast progressors."
A Drug Division at Odds With a Device Division
SYD 101 is going before an FDA committee specially comprised to review the data. This after the drug division of the FDA in October declined to approve it because, in their opinion, it wasn’t meaningful. Which raises all sorts of questions on how this government body views the myopia epidemic itself. This is in contrast to the device division, which has recently approved Stellest and hopefully others like Hoya DIMS (MiyoSmart), ZEISS (Miyocare) and Sight Glass (Vision Dot). Luckily, the Surgeon General is on record for the harm that excessive nearpoint activities can do to a child, including myopia.(8)
The Preventative-Care Profession We Were Meant to Be
The FDA approval of an LDA for myopia control will be a seminal moment for our profession. It will change how we interact and react with our patients and colleagues. It will foster a new age of specialization within our profession that will include OD to OD referral. It will move us closer to our dental colleagues who practice preventative care daily in the name of good oral hygiene and reduced rates of cavities. It will lead to new coding of the myopic condition with a disease label it has certainly earned, leading to an explosion of growth much like we have seen with Keratoconus and the now approaching billion dollar Scleral Lens industry. It will mean that we need to grow past all arbitrary labels we have hung onto in the past and finally be the preventative care profession we were always meant to be.(9)
We are at one of those moments again that I have discussed above, but in this case it’s our biggest moment yet. Whether we call it management or control, it matters little if we take that next step into preventative care. Our profession will be permanently changed for the better in the process.
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