SightGlass Vision, Inc. is reporting new research demonstrating the clinical impact of Diffusion Optics Technology (DOT) spectacle lens wear on myopic control among pediatric patients after 18 months.
Let’s start with a look at DOT.
Still under investigational evaluation in the U.S. (with FDA Breakthrough Device designation), SightGlass’s proprietary and patent-protected lens technology is designed to slow axial elongation (AL).
Its purpose: To provide stabilization or reduction of myopia progression by integrating thousands of light-scattering elements that imitate more natural contrast at all visual distances before reaching the retina.
- See here for details on the spectacle lenses DOT is embedded in (and its target patient base: pediatrics aged 6 to 13).
Has the tech received regulatory approval outside of the U.S.?
It has, actually—and has debuted in several countries’ commercial markets.
Among these: Canada, China, Israel, the Netherlands, Spain, and the United Kingdom.
Now to its clinical research: What’s been reported so far?
Promising real-world data: In 2023, DOT spectacle lens wear was linked to a decrease in myopic progression after 3 years—and even 4 years (based on an extension study).
The numbers: 65% of patients had no clinically meaningful myopia progression after 1 year of full-time wear, while 59% demonstrated reduced disease progression after 2 years
How about more recently?
This brings us to our current research topic: the CATHAY study (NCT05562622).
In fact, these new 18-month findings build on the previously-reported 12-month results presented earlier this year at the Association for Research and Vision in Ophthalmology (ARVO) annual meeting.
- As for the randomized study itself, which was conducted among nearly 200 Chinese pediatric patients (aged 6 to 13) diagnosed with myopia, details on its setup and outcome measures can be found here.
What did the 12-month data show?
DOT spectacle lens wear resulted in a significant slowing of myopia progression (versus single-vision lenses).
The numbers: Investigators observed a 75% reduction in cycloplegic spherical equivalent refraction (cSER), with a decrease of −0.48D (p<0.0001), as well as a 74% reduction in AL, with a decrease of 0.26 mm (p<0.0001).
- See here for more numbers.
Now to this 18-month update.
First: These results are being presented by Jennifer Hill, OD, during this week’s American Academy of Optometry (AAO) annual meeting in Boston, Massachusetts.
The data: A reported 57% of DOT lens-wearing patients demonstrated no clinically meaningful myopia progression at all (versus 15% in the single-vision lens control group).
- As for AL elongation and cSER progression, these same patients exhibited 0.34 mm and 0.70 D less than the control group, respectively.
Nice! Now, beyond this study, any other new data to be aware of?
Yes, actually … these include results from a Canadian-based study as well as two additional trials (one on North American and the other on Chinese patients)
Starting with the first: Kylvin Ho, OD, is presenting on 2-year clinical outcomes of younger patients.
The gist of the data: On average, DOT lenses slowed myopia progression by at least half—with the number of patients with stable refraction (0.50D changes or less) at:
- 52% for patients aged 6-7
- 62% for patients aged 8-10
And the other?
Debbie Laughton, director of Medical Affairs at SightGlass, is presenting 12-month data from two studies—one on North American patients and another on Chinese patients—on the connection between DOT lenses and astigmatism.
The highlights of these studies: While the data showed DOT lenses slowed myopic progression, no evidence suggested the lenses also caused an increase in astigmatism.
The numbers: After 12 months of lens wear, the number of astigmatic patients:
- Increased 5% (87% to 92%) among patients in the North American study
- Decreased 3% (91% to 88%) among patients in the Chinese study
Lots of new data!
Indeed, and that’s not even including a podium education session on the schedule for AAO. If you’re attending the meeting, consider attending.
- Those details: The session will be presented on Oct. 9 at 1:30 p.m. in Room 205 ABC.
- The topic: A comparison of research on different designs of spectacle lenses for myopia management—along with clinical tips.
- The presenters: Debbie Jones, OD, Jill Woods, OD, and Ashley Wallace-Tucker, OD, FAAO, FSLS, Dipl ABO.
All other research sessions from the company will reportedly be presented in the Exhibit Hall between 4:30 and 6:30 p.m. on Oct. 9.