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The Science

20+ Years of Safety Data: The Ortho-K Track Record

DJ
Dr. James Singletary, OD, FIAOMCOD, FIAOMC
July 26, 2025
8 min read
Clinically Reviewed  ·  March 2026
Reviewed by Dr. James Singletary, OD, FIAOMC
20+ Years of Safety Data: The Ortho-K Track Record

As an optometrist in Fayetteville with over two decades of experience, I’ve had the privilege of helping hundreds of children from Cumberland County and the surrounding Fort Liberty area see clearly without daytime glasses or contacts. My specialty, and my passion, is orthokeratology, or Ortho-K. It’s a technology that has been life-changing for so many of my young patients. Yet, the most common question I hear from parents is not about how it works, but a more fundamental one: “Is it safe?”

It’s a question I welcome. For parents, myself, I understand that your child’s health is your absolute top priority. When it comes to their eyes, you want to be certain that any treatment is not just effective, but also exceptionally safe. The idea of a lens worn overnight can sound intimidating. You might wonder about the risk of infection or other complications. Let me put your mind at ease. The truth is, Ortho-K has a remarkable safety track record spanning more than two decades, and when prescribed and managed by an experienced practitioner, it is one of the safest and most effective methods available for myopia control.

In This Article


The Ortho-K Safety Record: What 20+ Years of Data Tells Us

Ortho-K is not a new fad. The principles have been around for decades, but the modern era of overnight Ortho-K began with FDA clearance for the modality and approval of the first lens (Paragon CRT) in 2002. There is no FDA minimum age for Ortho-K. This approval wasn’t just a starting point; it was the beginning of a long and continuous process of safety monitoring and technological improvement. The FDA mandated post-market surveillance studies to track the performance and safety of these lenses in the real world, creating a vast and ever-growing body of data.

What does that data show? It shows that Ortho-K is a safe and reliable procedure. The key to this safety lies in a combination of advanced lens technology, rigorous practitioner training, and—most importantly—patient and parent commitment to proper hygiene. Early concerns in the first few years after approval were largely traced back to poor compliance and hygiene practices. This led to a massive educational push from eye care professionals, and the results speak for themselves. The rate of complications has dropped dramatically as awareness and best practices have become standard procedure.

Complication Rates: Ortho-K vs. Other Vision Corrections

To truly understand the safety profile of Ortho-K, it’s helpful to compare it to other common forms of vision correction. No method is entirely without risk, but the numbers might surprise you. The most significant potential risk with any contact lens, including Ortho-K, is microbial keratitis (MK), an infection of the cornea. While serious, it is also very rare, especially when proper hygiene is followed.

Let’s look at the data. Studies have consistently shown that the rate of MK in overnight Ortho-K wearers is comparable to that of other overnight soft contact lens wearers. It’s a risk we take seriously, but one that is managed effectively with proper care.


A bar chart comparing the complication rates of Ortho-K to soft contact lenses, showing similar low rates of microbial keratitis.

Chart showing the low incidence of microbial keratitis in Ortho-K, which is comparable to other overnight contact lens modalities.


Here is a more detailed comparison of the estimated annual incidence of microbial keratitis per 10,000 wearers across different vision correction options:

Vision Correction MethodEstimated Annual MK Cases (per 10,000 wearers)Notes
Overnight Ortho-K~13.9Primarily associated with hygiene compliance.
Daily Wear Soft Lenses~4Lower risk due to no overnight wear.
Overnight Soft Lenses~20Highest risk among contact lens types.
Rigid Gas Permeable (RGP) Lenses~1.2Lower risk due to material properties.
LASIK Surgery~5-10 (in first year)Risk is concentrated post-operatively.

As you can see, the risk associated with Ortho-K is well within the range of other common contact lens options and is significantly influenced by user behavior.

The Role of Proper Hygiene and Professional Care

I cannot overstate this: the safety of Ortho-K is inextricably linked to proper hygiene. The vast majority of complications are preventable. At our clinic, we have a rigorous training protocol for every new patient and their parents. We don’t just hand you the lenses and a bottle of solution; we walk you through the entire process, step-by-step, until you are completely confident.

Your partnership is the key to success. This includes:

  • Hand Washing: Always washing hands thoroughly with soap and water and drying with a lint-free towel before handling the lenses.
  • Approved Solutions: Only using the specific cleaning and disinfecting solutions prescribed. Never use tap water!
  • Case Care: Cleaning the lens case daily and replacing it regularly, as recommended.
  • Following the Schedule: Adhering strictly to the wearing schedule and follow-up appointments.

These appointments are critical. They allow me to monitor the health of your child’s eyes, ensure the lenses are fitting perfectly, and answer any questions you have. It’s a team effort, and I’m your partner every step of the way.


A closeup image of a modern Ortho-K lens, showing its intricate design and high-quality material.

Modern Ortho-K lenses are made from highly oxygen-permeable materials, crucial for overnight corneal health.


Modern Advancements in Ortho-K Safety

Today’s Ortho-K is not the same as it was 20 years ago. The technology has evolved significantly, with safety as the driving force behind the innovation. One of the biggest breakthroughs has been in lens materials. Modern Ortho-K lenses are made from highly advanced, hyper-oxygen permeable materials. This is crucial because the cornea gets its oxygen directly from the air. These materials allow for maximum oxygen transmission to the cornea, even during overnight wear, which is essential for maintaining excellent eye health.

Furthermore, the diagnostic and design technology has become incredibly precise. We use a device called a corneal topographer to create a detailed, 3D map of your child’s cornea. This map, as unique as a fingerprint, allows us to design a custom lens that fits perfectly, ensuring both comfort and safety. This level of customization was unimaginable in the early days and has played a huge role in reducing complication rates over time.


A line graph showing the rate of microbial keratitis (MK) associated with Ortho-K decreasing over time as lens technology and practitioner education have improved.

The incidence of microbial keratitis with Ortho-K has declined over the past two decades thanks to better materials and stringent clinical protocols.


What Parents in Fayetteville and Cumberland County Should Know

Here in the

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Free Download: The Science Behind Ortho-K

A plain-language summary of 12 key clinical studies on orthokeratology efficacy.

  • Summary of 12 peer-reviewed clinical studies
  • Myopia progression rates with/without treatment
  • Ortho-K vs. atropine vs. multifocal lenses
  • FDA approval history and safety data

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DJ

Dr. James Singletary, OD, FIAOMC

Dr. James Singletary, OD, FIAOMC is a licensed optometrist and orthokeratology specialist with over 15 years of clinical experience in myopia control, myopia management, orthokeratology, and nonsurgical vision correction. He is the founder of Eye Medics Optometry in Fayetteville, NC and the creator of the sleepSEE ortho-k program.

Medical Disclaimer

This article is for informational purposes only and does not constitute medical advice. Always consult with a qualified eye care professional for diagnosis and treatment of eye conditions. The information provided here should not be used as a substitute for professional medical advice.

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