What HbA1c Number Is Peak for DR?

HOT TOPIC

Myopia Management Sector Remains Active

HOYA Vision Care recently presented new clinical evidence on myopia management. The company introduced the visuReal MoveAI Kids Module at the 16th Annual European Academy of Optometry and Optics conference in Ljubljana, Slovenia. The visuReal MoveAI Kids Module is an AI-powered video centration system for fitting children’s eye wear. At the global debut, the company stated the visuReal MoveAI is a “flexible, accurate, and user-friendly portable digital centration solution.” It also stated that with its integrated application, intuitive interface, and AI-powered automated detection, the visuReal MoveAI will make lens centration faster and easier.

Not only did HOYA Vision Care present this new fitting solution, but it also shared several updates from its ongoing research in myopia management, including 8-year results from the longest-running clinical study on myopia management spectacle lenses. According to the company, these data show that “wearing MiYOSMART spectacle lenses continuously and for the long-term provides an effective, safe, noninvasive myopia management strategy in children, with maximum benefits achieved through continuous wear.”

A 2-year observational study of 103 European children 5 to 15 years of age showed that the defocus incorporated multifocal segments (DIMS) spectacle lenses tested were similarly effective in slowing myopia progression in both UK and Hong Kong pediatric populations. The company believes this shows evidence for long-term continuous myopia management spectacle lens wear in myopic populations worldwide.

My Two Cents

Admittedly, I don’t actively follow the myopia management field as well as some of my fellow optometry friends. However, it seems there are significant data that prove the efficacy of these specialized spectacle lenses. What exactly is the holdup with getting them approved? Can someone fill me in?

My research shows there are (obviously) no FDA-approved myopia management spectacle lenses for use in the United States; however, there appear to be at least three candidates that will hopefully be approved in the near future. These are (in no particular order):

Stellest lenses (Essilor) use highly aspherical lenslet technology and, according to the company, have been shown to slow myopia progression by 63% to 64% over 1 year, with up to 1.75 D progression over 5 years, as demonstrated in clinical trials. In May 2021, Stellest lenses received FDA Breakthrough Device designation, but not much has happened since then. These lenses are already available to our northern neighbors in Canada.

Diffusion Optics Technology spectacle lenses (SightGlass Vision). The technology in these glasses reduces retinal contrast and received FDA breakthrough device designation in February 2024. The CYPRESS clinical study demonstrated a 59% to 74% reduction in myopia progression and a 33% to 50% reduction in axial elongation over 2 years. Diffusion Optics Technology spectacle lenses are available in China, the Netherlands, and Israel.

MiYOSMART spectacle lenses (Hoya) feature the DIMS technology mentioned above. They have shown a 59% reduction in myopia progression and a 52% reduction in axial elongation in a 2-year study with consistent results over 6 years. To my knowledge, these have not received FDA breakthrough device designation. They are available in more than 30 countries, including Canada.

OUTSIDE THE LANE

HbA1c and Type 2 Diabetes Risk: What’s the Link?

HbA1c and Type 2 Diabetes Risk: What’s the Link? A study published in BMC Ophthalmology revealed a non-linear relationship between hemoglobin A1c (HbA1c) levels and risk of diabetic retinopathy (DR) in patients with type 2 diabetes, challenging the assumption that higher HbA1c always correlates with increased risk.

The study was a cross-sectional investigation that included 2,001 patients with type 2 diabetes who were evaluated in southern Taiwan. Study researchers measured HbA1c levels and analyzed the association between those levels and DR. Outcomes showed that HbA1c positively correlated with the appearance of DR; however, this relationship was represented by an inverted U-shaped association, with DR risk reaching a peak at a 9.4% HbA1c level, then starting to decline. This was found to be true for all ages, sexes, and BMI categories. The study authors explained that every 1% increase in HbA1c was associated with a 7% increase in the odds of developing DR.

The peak at 9.4% may be due to metabolic memory. Long-term hyperglycemia may create a metabolic memory-sustaining DR risk even after glycemic control is established. When a patient has a very high HbA1c, this metabolic memory has been established, so higher levels of HbA1c may add to the risk. Others postulate that diabetic-induced microvascular damage is irreversible in many ways, so higher levels of HbA1c may cause limited additional harm.

My Two Cents

Woah, woah, woah. This is a finding I would have never expected. Again, according to the authors of this study, “Patients near the 9.4% HbA1c threshold need closer monitoring and timely intervention.” There absolutely needs to be more research into this, including a worldwide study that does not focus solely on an extremely small area of the world, such as Taiwan. Regardless, I thought this was an interesting enough study that warranted being highlighted in this week’s newsletter.

CAN YOU RELATE

Most of us have those moments in our lives where we wish we would have acted on a great idea and taken a leap of faith.

I thought my life’s unique business opportunity was the creation of The Dry Eye Drink, but then came the Eyedration Air-Activated Steam Mask, and over the past few years, I’ve been working on my next big business idea, which will help patients and independent practices succeed. It’s taken about 3 years of tinkering and perfecting, but it’s finally about to be unveiled! Check me out at booth #842 in the Aesthetics Alley area of the exhibit hall during the American Optometric Association’s annual meeting next month. Readers of this newsletter will get to sample some new products in the coming months, so stay tuned!

All this to say that when an opportunity presents itself, remember: You only live once! Seriously, consider jumping headfirst into opportunity—especially if it can help your patient base and/or your friends and colleagues. Besides, nothing ventured, nothing gained!

QUOTE OF THE WEEK

“Pearls don’t lie on the seashore. If you want one, you must dive for it.”

— Ancient Chinese proverb