Stellest Lenses: Clinical Research and Results

Understanding FDA Authorization

Understanding FDA Authorization

When making decisions about your child's vision, you want to know the treatment is backed by solid science. Stellest lenses have undergone rigorous clinical testing and earned FDA authorization as the first eyeglass lenses designed to help slow myopia progression in children.

In September 2025, Stellest lenses received FDA authorization through a rigorous review process. This was the result of years of clinical trials, thousands of data points, and careful evaluation by independent scientists and medical reviewers.

  • Stellest met strict standards for both safety and effectiveness
  • The clinical data was reviewed by independent reviewers
  • The lenses are classified as a medical device, not just regular glasses
  • Eye doctors can confidently recommend them based on proven results
  • This is the first time eyeglass lenses have received FDA authorization specifically for slowing myopia

Think of FDA authorization like the difference between a supplement you buy online with questionable claims versus a prescription medication that has been through years of testing. FDA authorization provides assurance that what you are getting actually works as claimed.

The Clinical Trial Design

The Clinical Trial Design

The research supporting Stellest was a large scale, carefully designed clinical trial that followed the gold standard for medical research. The study followed strict scientific protocols to ensure the results were accurate and reliable.

  • Children were randomly assigned to either Stellest lenses or regular glasses
  • Researchers measuring the results did not know which children had which lenses
  • Children were ages 6 to 12 years old at the start of the study
  • The study lasted two full years
  • Children were monitored regularly to ensure safety

Two years might not sound like a long time, but in myopia research, it is significant. Children's eyes can change rapidly during these growing years. A two year study captures meaningful progression and demonstrates that the treatment effect is sustained over time, not just a temporary result.

During two years, a child with progressive myopia might naturally develop an additional 1.00 to 2.00 diopters without treatment. That is the difference between mild myopia and moderate myopia, or moderate myopia and high myopia. Slowing that progression during this critical period provides lasting benefits that extend into adulthood.

This type of study design, called a randomized controlled trial, is considered the gold standard because it eliminates bias and provides the most reliable evidence. It is the same type of study used to test new medications before they are approved.

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Clinical Trial Results

Clinical Trial Results

The clinical trial results were consistent. Children wearing Stellest lenses showed significantly slower myopia progression compared to children wearing regular glasses.

  • 67% less increase in their prescription strength
  • 53% less physical growth in the length of their eyeballs
  • Consistent results throughout the entire two year period
  • Benefits that were seen across all age groups in the study

Imagine two 8 year old children, both starting with negative 1.00 diopter of myopia. One wears regular glasses, the other wears Stellest lenses. Both wear their glasses consistently for two years.

After two years, the child in regular glasses might progress to negative 3.00 diopters. The child in Stellest lenses might progress to only negative 1.60 diopters. That is a difference of 1.40 diopters saved.

That difference of 1.40 diopters provides significant long term protection. Research suggests that each diopter of myopia reduction may decrease the risk of myopic macular degeneration by approximately 40%. Reducing final myopia helps lower the risk of vision threatening complications throughout your child's lifetime.

You might wonder why researchers measured both prescription changes and eye length. Eye length matters even more than the prescription number.

Myopia happens because the eyeball grows too long. As it stretches, the tissues inside get thinner and more fragile, like stretching a balloon. This stretching and thinning creates all the disease risks: retinal detachment, macular degeneration, glaucoma, and early cataracts.

When Stellest slows the physical growth of the eyeball by 53%, it directly addresses the root cause of those future complications. It is not just making the prescription weaker. It is preventing the structural changes that lead to disease.

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Comparing Myopia Treatments

Based on clinical trial data, different myopia management treatments show varying levels of effectiveness.

  • Stellest lenses: approximately 67% reduction in prescription progression, 53% reduction in eye length growth
  • MiSight contact lenses: approximately 59% reduction in prescription progression, 52% reduction in eye length growth
  • Orthokeratology: 36% to 56% reduction in progression depending on the study
  • Low dose atropine: effectiveness varies significantly by concentration and population

All four of these treatments work. They have all been validated through rigorous research. They all significantly slow myopia progression compared to doing nothing.

The differences in percentages between these treatments are relatively small when you consider real world use. A treatment showing 75% efficacy that your child uses inconsistently will provide worse results than a treatment showing 60% efficacy that your child uses every day.

The best treatment is the one your child will actually wear consistently, that fits your family's lifestyle, and that you can sustain for years. That is why Insight Vision Center Optometry offers all four options and helps you choose based on your child's individual needs rather than pushing one treatment as universally superior.

Safety Information

Safety Information

Throughout the two year clinical trial, researchers carefully monitored children for any safety concerns or side effects.

  • No serious side effects related to wearing Stellest lenses
  • No difference in vision quality between Stellest wearers and regular glasses wearers
  • No problems with eye coordination or focusing ability
  • Children adapted to the lenses quickly and comfortably
  • No reports of headaches, dizziness, or visual disturbances from the lens design

Parents often worry that the special lens design with tiny lenslets might be distracting or uncomfortable for their child. The research shows these concerns are unfounded.

  • Clear, comfortable vision for all daily activities
  • No awareness of the lenslets during normal use
  • No difference in how things looked compared to regular glasses
  • Easy adaptation within the first few days of wear
  • Ability to participate fully in school, sports, and play

The lenslets work in the peripheral part of the lens, outside where your child actually looks. Think of them like a security system working quietly in the background. Your child does not see them or notice them, but they are working continuously to slow myopia progression.

Consistent Wear Requirements

Consistent Wear Requirements

The research showed a clear relationship between how many hours per day children wore Stellest and how well the treatment worked. More hours meant better results.

Think of it like taking medication. If your eye doctor prescribes an antibiotic three times daily for 10 days, taking it only once a day or skipping days reduces effectiveness. Stellest works the same way. The clinical trial results reflect children who wore the lenses consistently throughout the day.

For optimal results, consistent daily wear of at least 10 to 12 hours is recommended, similar to protocols used in myopia management research.

  • Aim for 12 or more hours of daily wear
  • Minimum of 10 hours daily to match study conditions
  • Consistent wear 7 days per week, not just school days
  • The more hours worn, the better the protection
  • Missing occasional days will not ruin treatment, but consistency matters

Long Term Benefits

Long Term Benefits

The clinical trial lasted two years, but your child will benefit from myopia management for much longer if treatment begins early and continues through their growing years.

Consider a child starting treatment at age 7 and continuing through age 14. Without treatment, they might accumulate 5.00 to 6.00 diopters over 7 years. With Stellest, they might accumulate only 1.50 to 2.00 diopters over the same period. That total protection of 3.50 to 4.00 diopters saved is significant.

That 3.50 to 4.00 diopter difference is often the difference between low myopia with minimal disease risk versus high myopia with significantly elevated risk of serious complications. Our children's vision symptom checker can help you identify early signs that your child may be developing myopia.

Scientific honesty requires acknowledging what we do not yet know. The current research provides strong evidence for Stellest's safety and effectiveness, but some questions remain under investigation.

  • How long should children continue wearing Stellest for maximum benefit
  • Does the treatment effect continue beyond two years
  • Which children respond best to Stellest treatment
  • How does Stellest perform when combined with other treatments like low dose atropine
  • What happens if children stop treatment

These are important questions, and research is ongoing. However, the absence of complete answers should not delay decision making. We have strong evidence that Stellest works, that it is safe, and that starting early provides maximum benefit.

Myopia Management at Insight Vision Center Optometry

Myopia Management at Insight Vision Center Optometry

Understanding the research is one thing. Applying it to your child's individual situation requires training and experience. At Insight Vision Center Optometry, our fellowship trained team stays current with the latest myopia research and translates that evidence into practical, personalized care for every child we see.

Dr. Thanh Mai, OD, FSLS, FIAOMC serves as VP of Clinical Innovation for Treehouse Eyes and sits on the EssilorLuxottica advisory board for Stellest. This national level engagement ensures our practice remains current with emerging research and best practices.

We bring a thorough, evidence-based approach to every myopia management case.

  • Understanding of clinical trial data and real world applications
  • Experience fitting and monitoring children in Stellest lenses
  • Access to the Zeiss AXL WAVE Optical Biometer for precise axial length measurement
  • Training in all four proven myopia management modalities for individualized recommendations
  • Ongoing education as new research emerges

Our optometrists bring unique qualifications to myopia management care.

  • Dr. Thanh Mai, OD, FSLS, FIAOMC: Treehouse Eyes VP of Clinical Innovation, EssilorLuxottica advisory board for Stellest, FIAOMC fellowship
  • Dr. Nathan Schramm, OD, FSLS, FBCLA: Principal investigator for the Euclid Phoenix ortho-k trial (2023-2024), AAOMC presentations
  • Dr. Ariel Chen, OD: Euclid Phoenix trial co-investigator, ortho-k and atropine protocols
  • Dr. Valerie Lam, OD, FAAO, FOVDR: Pediatric myopia, myopia with concurrent vision therapy needs
  • Dr. Nhi Nguyen, OD: Treehouse Eyes affiliation, ortho-k

Schedule a Myopia Evaluation

Schedule a Myopia Evaluation

Insight Vision Center Optometry offers a complimentary myopia evaluation where we will discuss your child's current prescription and progression rate, how the clinical trial results apply to your child's specific situation, and whether your child meets the criteria from the research studies.

We will also cover expected outcomes based on evidence and your child's risk factors, how Stellest compares to other proven options for your child, realistic expectations about treatment commitment and compliance, and monitoring protocols to verify treatment effectiveness over time.

Call us schedule your child's myopia evaluation, or speak with our Myopia Management Care Coordinator for a phone consultation. This evaluation provides everything you need to make a confident, informed decision grounded in science.

Frequently Asked Questions

The clinical trial included children ages 6 to 12 years old. Earlier intervention typically provides greater cumulative benefit because there are more years of rapid eye growth to slow down. Your child's eye doctor can help determine the right starting point based on their prescription, rate of progression, and other individual factors.

Yes. Children in the clinical trial participated fully in school, sports, and play without difficulty. The lenses provide clear, comfortable vision for all daily activities. If your child plays contact sports, you may want to discuss protective eyewear options with your eye doctor.

Consistency directly affects results. The strong outcomes from clinical trials reflect children who wore their lenses 10 to 12 hours daily. Occasional missed days will not ruin treatment, but regular skipping will reduce effectiveness.

Your eye doctor will monitor your child's progress with regular measurements of both prescription changes and eye length using the Zeiss AXL WAVE Optical Biometer. Comparing these measurements over time shows whether myopia progression is slowing as expected. If results are not meeting expectations, adjustments can be made to the treatment plan.

Most children with progressive myopia are good candidates for Stellest. However, children who cannot wear glasses consistently, those with certain eye conditions, or those who strongly prefer contact lenses might be better suited for other myopia management options. A thorough evaluation helps determine the best approach for each child.

Research is still exploring combination approaches. Some eye doctors combine spectacle lenses with low dose atropine drops. Your eye doctor can discuss whether combination therapy might be appropriate for your child based on their specific situation and the latest available evidence.

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