De Novo authorization
The FDA granted Essilor of America a De Novo request on September 25, 2025, after a 2021 Breakthrough Device designation.
Myopia management · Eyeglass lenses
Myopia Control Spectacle Lenses The option for kids who are not ready for contacts.
Lenslet and defocus spectacle designs keep a clear center for sharp vision and add peripheral myopic defocus. In September 2025 the FDA authorized Essilor Stellest, the first eyeglass lens in the US cleared to slow myopia progression in children.
6–12Stellest age range at the start of treatment
71%Less refractive progression at 24 months in the FDA-reviewed study
53%Less axial elongation in the same study
9 mmClear central zone ringed by lenslets
How it works
A clear center with a defocus ring
The child looks through a single vision center. Around it, small raised lenslets focus light in front of the peripheral retina, the signal linked to slower axial growth.
Younger patients
The 6 to 12 indication reaches 6- and 7-year-olds and children who cannot handle contact lenses.
Wear time matters
In the pivotal randomized trial, children who wore the lenses at least 12 hours a day had the largest effect.
Side effects
No serious adverse events were reported. Some children noted blur or halos, and the label lists no contraindications.
Other designs
SightGlass Vision's DOT lens holds an FDA Breakthrough Device designation. HOYA's DIMS design has published trial data but no US authorization.
What the evidence shows
Randomized trials of lenslet and defocus spectacles report slower refractive progression and eye growth versus single vision lenses.
- Lowest-risk optical option
- Works with the glasses kids already wear
- Compliance drives results
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Highly aspherical lenslets
Over two years, Stellest-type lenslets slowed refractive change by 0.80 D and axial growth by 0.35 mm versus single vision lenses.
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Full-time wearers
Children wearing them 12 or more hours daily saw progression slowed by 0.99 D and elongation by 0.41 mm.
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Defocus segments
A two-year DIMS trial reported 52% slower progression and 62% less axial elongation.
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Diffusion optics
SightGlass DOT lenses reduce retinal contrast instead of adding defocus; its CYPRESS trial reported 12-month results.
In the practice
Dispensing myopia control eyewear
The optical runs the order like any specialty lens. The difference is the measurement and the coaching around wear time.
Measure first
Cycloplegic refraction and axial length set the baseline and justify the plan to the family.
Fit for centration
Accurate monocular PD and fitting height keep the clear zone over the pupil. Choose frames that sit stable on a child's face.
Coach wear time
Set the expectation of all-day wear, then check refraction, axial length and frame fit at each recheck.
Design comparison
Myopia control spectacle designs
| Essilor Stellest | Lenslets around a 9 mm clear zone; FDA De Novo authorization, Sept 25, 2025; ages 6 to 12 at start |
|---|---|
| SightGlass Vision DOT | Diffusion optics; FDA Breakthrough Device designation (2024) |
| HOYA MiyoSmart (DIMS) | Defocus segments; two-year randomized trial published 2020; no US authorization found |
| Single vision lenses | Correct blur only; the control arm in these trials |
| Pricing | Set by the optical; often bundled into a myopia program fee |
| Ordering | Through the manufacturer's authorized lab network |
Questions doctors ask about myopia control glasses
Is Stellest FDA approved?
It received FDA marketing authorization through the De Novo pathway on September 25, 2025, to correct myopia and slow its progression in children 6 to 12 at the start of treatment.
How many hours a day should a child wear them?
The trials tied the best results to at least 12 hours of daily wear. Confirm current guidance in the manufacturer's labeling.
Can glasses be combined with atropine?
Some clinicians combine optical and pharmaceutical approaches. It is a clinical judgment for the prescriber.
Who is a good candidate?
Younger children, kids not ready for lens care and families who want the lowest-risk option.
Do eyeglass orders earn the 15% participation credit?
No. The credit applies to eligible OTC orders on VisionRescue.com through RescueLink, such as lens cleaners and wipes.
References
- US FDA. FDA authorizes marketing of first eyeglass lenses to slow progression of pediatric myopia. September 25, 2025. FDA
- Bao J, Huang Y, Li X, et al. Spectacle lenses with aspherical lenslets for myopia control vs single-vision spectacle lenses: a randomized clinical trial. JAMA Ophthalmol. 2022;140(5):472-478. PubMed
- Lam CSY, Tang WC, Tse DY, et al. Defocus Incorporated Multiple Segments (DIMS) spectacle lenses slow myopia progression: a 2-year randomised clinical trial. Br J Ophthalmol. 2020;104(3):363-368. PubMed
- Rappon J, Chung C, Young G, et al. Control of myopia using diffusion optics spectacle lenses: 12-month results (CYPRESS). Br J Ophthalmol. 2023;107(11):1709-1715. PubMed
Give every family an option without contacts.
Spectacle myopia control fits naturally into the optical you already run.
Stellest, DOT and MiyoSmart are trademarks of their respective owners. Review each manufacturer's labeling before dispensing. Individual results vary.