Evidence Summary: Stellest Clinical Trials at 1 to 3 Years
Understanding Stellest Technology and the Clinical Research Program
Stellest lenses are eyeglasses designed specifically to slow myopia progression in children. They use a special optical design with hundreds of tiny segments called lenslets across the lens surface.
These lenslets create a myopic defocus signal in front of the retina, which researchers hypothesize may slow the eye's growth. The central zone of the lens still provides clear vision for daily activities, while the surrounding treatment zone works to manage myopia.
Indications, regulatory status, and availability of Stellest lenses vary by country and region. Your eye care professional will confirm whether these lenses are appropriate for your child based on individual factors and local standards of care.
The primary evidence for Stellest lenses comes from a randomized controlled trial program evaluating spectacle lenses with highly aspherical lenslets, sometimes referred to as HAL spectacle lenses. This program was conducted primarily in China, with additional studies in Europe, and followed children for one to three years.
Key characteristics of the core trial program include the following:
- Randomized, controlled design comparing Stellest type lenses to single vision spectacles
- Approximately 170 children enrolled in the primary randomized cohort, with extension follow up for multiyear data
- Children aged 8 to 13 years with myopia ranging approximately negative 0.75 to negative 4.75 diopters
- Astigmatism limit typically negative 1.50 diopters or less
- Primary outcomes were cycloplegic spherical equivalent refraction and axial length measured every six months
The clinical trials typically enrolled children between ages 8 and 13 who had myopia. Most studies required children to have a certain level of myopia and the ability to wear glasses comfortably throughout the day.
- Children needed to have healthy eyes without other serious vision problems
- Participants had to be able to follow study instructions and attend regular visits
- Most trials included children with mild to moderate myopia at the start
- Some studies allowed children with small amounts of astigmatism to participate
Myopia progression happens over several years, especially during childhood and the teenage years. One-year results give us early information, but longer studies show whether treatment effects continue over time.
Three-year data helps your eye care professional understand whether children maintain the benefit or whether effectiveness changes as they grow. This longer view is essential for setting realistic expectations and planning your child's ongoing care.
Trial Design: How Researchers Measured Myopia Control
Axial length is the distance from the front to the back of your child's eye. As myopia worsens, this measurement increases because the eye is growing too long.
Researchers measured axial length using a device called an optical biometer, which gives very precise readings. This measurement is considered a gold standard for tracking myopia progression because it directly shows how much the eye is growing, and it is used alongside refraction to assess treatment response.
The trials also tracked changes in your child's eyeglass prescription over time. This measurement, called spherical equivalent refraction, tells us how much the focusing power of the eye has changed.
Refraction was measured under cycloplegia, which means eye drops were used to temporarily relax the focusing muscles, in the main trials to improve accuracy and comparability across visits and between children.
- A larger negative number means the myopia has progressed more
- Prescription changes often correlate with axial length growth
- Most trials measured refraction every six months during the study
- Researchers used standardized methods to ensure accurate comparisons
To understand how well Stellest works, researchers compared children wearing these lenses to children wearing regular single-vision eyeglasses. The control group wore standard glasses without any myopia management features.
Comparing the two groups allowed researchers to calculate how much additional benefit Stellest provided beyond regular glasses. This comparison is crucial for determining whether the treatment truly slows myopia progression.
Trial participants visited the eye clinic regularly so researchers could track their progress carefully. Most studies scheduled visits every three to six months for measurements and eye health checks.
At each visit, children received comprehensive eye exams including axial length measurements, refraction tests, and evaluations of eye health. Consistent monitoring ensured that researchers captured accurate data and could detect any problems early.
Efficacy Results Across 1 to 3 Years
The trials showed that children wearing Stellest lenses had significantly less eye growth compared to those wearing regular glasses. Over the first year, the treatment group showed reductions in axial elongation, with higher relative control rates reported at two years, where some studies found approximately 60 to 67 percent less axial elongation than the control group.
This benefit continued through three years of wear in extension cohorts, with sustained control rates often above 50 percent. Absolute differences in axial length growth between treated and control groups were on the order of a few tenths of a millimeter over one to three years. Percent reductions are relative to the control group and can vary by baseline progression rate and analysis approach.
Changes in eyeglass prescription followed a similar pattern to axial length results. Children in the Stellest groups had smaller increases in their myopia prescription compared to children wearing regular glasses, with absolute differences typically around 0.50 to 0.75 diopters over two years in published reports.
- Treatment groups showed reductions in prescription progression that varied by timepoint and cohort
- The benefit persisted through multiple years of the studies
- Results varied somewhat between individual children
- Not all children experienced the same degree of slowing
- Results are averages and individual outcomes vary widely
The trials reported that a substantial percentage of children wearing Stellest showed clinically meaningful myopia control. Some studies found that more than half of the treatment group had very slow progression or even stable myopia during the study period.
However, individual responses varied, and some children continued to progress despite treatment. Your eye care professional considers these population-level results alongside your child's specific situation when discussing expected outcomes.
Younger children in the trials often showed greater myopia progression in the control groups, which meant there was more progression to slow. The treatment effect in younger versus older children varied across different studies.
Age is one of several factors we consider when predicting how well your child might respond to Stellest lenses. Children who are progressing rapidly at baseline may have different outcomes than those with slower progression.
Compliance with wearing the glasses was important for achieving good results in the trials. Children who wore their Stellest lenses for more hours per day generally showed better myopia control.
Studies that tracked wearing time found that consistent daily use was associated with greater treatment benefits. Trial protocols typically instructed children to wear the lenses full time during waking hours, often with a minimum threshold such as at least 12 hours per day, to maximize the potential for slowing myopia progression.
While the Stellest clinical trial program provides valuable information, there are important gaps and limitations in the current evidence base. Understanding these limitations helps set realistic expectations and highlights areas where clinical judgment is necessary.
Three-year outcomes are often derived from extension studies or open-label follow-up cohorts rather than the original randomized design, which may introduce bias. Several important questions remain incompletely answered by the current trial data.
- Limited ethnic and geographic diversity in the core randomized controlled trials
- Adherence measurement often relied on parent or child report rather than objective monitoring
- No head-to-head randomized trials comparing Stellest to other myopia control interventions such as atropine or orthokeratology
- Unknown durability of treatment effect if lenses are discontinued or if wear time decreases over time
- Variability in individual response is not fully explained by baseline characteristics
- Longer term effects beyond three years and into adulthood remain under investigation
Safety Profile and Side Effects in the Clinical Trials
Most children in the trials adapted to Stellest lenses within a few days to two weeks. Some children noticed the unique optical design initially, but these sensations typically decreased as they got used to the lenses.
Initial use during routine indoor activities is often recommended, with caution on stairs or during sports in the first few days if spatial perception feels different. If discomfort or visual disturbances persist beyond the first two weeks, returning for a frame adjustment or centration check can improve comfort.
- Mild peripheral blur or awareness of the lenslets was occasionally reported
- Most children found the lenses comfortable for reading and other close work
- Very few children discontinued due to visual discomfort
The trials showed that children wearing Stellest lenses achieved excellent visual acuity for distance and near tasks. The central optical zone of the lens provided clear, sharp vision comparable to regular eyeglasses.
Researchers measured visual acuity at each visit and found no clinically significant difference between children wearing Stellest and those wearing single-vision lenses. Your child should be able to see clearly for schoolwork, sports, and daily activities.
Serious adverse events related to the lenses themselves were rare in the clinical trials. Most side effects were mild and resolved on their own or with minor adjustments.
The studies tracked all health issues that occurred during the trial period, including those unrelated to the lenses. No increase in the risk of eye infections, injuries, or other significant problems was observed within the study size and follow-up, and no new safety signal was identified compared with single-vision spectacles.
Some children did experience visual or comfort-related symptoms, particularly during the adaptation period:
- Mild ghosting or peripheral blur awareness in some lighting conditions
- Mild headaches or eye strain during the first days to weeks of adaptation
- Occasional glare or halo complaints in bright or nighttime settings
- Need for careful frame adjustment and lens centration for best comfort and performance
The trials reported dropout rates that varied by study length and location, with longer studies naturally having higher dropout rates. Common reasons for leaving included moving away, difficulty attending regular visits, or family preference.
Very few children discontinued specifically because of problems with the Stellest lenses themselves. The overall retention rates in most trials were good, suggesting that families found the treatment acceptable over multiple years.
What This Evidence Means for Your Child
When we consider myopia management options for your child, we look at how different treatments compare in research studies. Cross-study comparisons are indirect because trials differ in participant age, baseline myopia, outcome measurement methods, and adherence monitoring, so we must interpret these comparisons cautiously.
Stellest trials showed efficacy rates that may be similar in magnitude to those reported for some other optical interventions such as certain multifocal soft contact lenses and orthokeratology, though no head-to-head randomized trials have been conducted. Low-dose atropine eye drops are another common myopia management option in 2025, and some practitioners consider combination therapy with optical treatment and atropine, though evidence for combinations is still emerging.
The best choice for your child depends on multiple factors including age, lifestyle, comfort with different types of correction, and family preferences. We may recommend Stellest lenses if your child is a good candidate for eyeglasses and you prefer a non-contact lens option.
The trial data suggests that children who are actively progressing and can commit to full-time wear are likely to gain the most benefit. Evidence is strongest for children similar to trial participants, approximately ages 8 to 13 with mild to moderate myopia (roughly negative 1 to negative 5 diopters) and limited astigmatism.
- Children who prefer glasses over contact lenses may find Stellest appealing
- Those with mild to moderate myopia at the start showed good responses in trials
- Families who can attend regular monitoring visits support better outcomes
- Children who wear their glasses consistently throughout the day match the study protocols most closely
While the trial results are encouraging, we want you to understand that myopia control does not mean stopping progression completely in most cases. The goal is to slow the rate of progression, which can make a meaningful difference in your child's final prescription and long-term eye health.
Some children will respond better than others, and we cannot predict with certainty how much benefit your individual child will experience. Even with good initial response, progression often continues, and treatment effects can vary over time. We use the trial data as a guide, but we also monitor your child's actual response and adjust recommendations accordingly.
Myopia management works best when combined with healthy vision habits. Research continues to explore how environmental and lifestyle factors affect myopia progression, and we incorporate current understanding into our recommendations.
Encouraging outdoor time, managing prolonged near work, and ensuring good lighting for reading and screen use may support your child's overall eye health. While these measures alone may not control myopia as effectively as optical treatments, they complement your child's use of Stellest lenses.
Based on the trial protocols and current clinical standards in 2025, we typically recommend eye exams every six months for children wearing myopia control lenses. Shorter intervals, such as every three to four months, may be appropriate early in treatment, for children with rapid progression, or if symptoms arise.
These visits allow us to measure axial length where available, update the prescription if needed, and check overall eye health. Axial length measurement equipment availability varies by clinic and region, so your eye care professional will use the best tools accessible to track your child's progress. Regular monitoring helps us understand whether the treatment is working for your child and whether any adjustments are needed.
While Stellest lenses are safe, you should contact our office if your child experiences certain symptoms between regular visits. Early reporting helps us address problems before they become more serious.
- Sudden decrease in vision that does not improve by cleaning the glasses
- Eye pain, redness, or unusual discharge
- Persistent headaches that seem related to wearing the glasses
- Significant difficulty adapting after the first two weeks
- Any injury to the eye or glasses that might affect safety
- New flashes of light, shower of floaters, or curtain or shadow in vision
- Sudden severe light sensitivity with redness or tearing
- Significant blunt trauma to the eye or area around the eye
- Sudden double vision or severe headache with neurologic symptoms
Frequently Asked Questions
Yes, the main Stellest clinical trial results have been published in peer-reviewed scientific journals where independent experts evaluated the research methods and findings. Publication in these journals adds credibility to the evidence and allows eye care professionals worldwide to review the data.
Some of the trials allowed children with low to moderate amounts of astigmatism to participate, typically up to about negative 1.50 diopters, while others enrolled only children with myopia alone. Children with certain other eye conditions or health problems were typically excluded to ensure safety and allow clear interpretation of the myopia control results.
Children in the trials participated in normal daily activities including sports, and the lenses did not pose additional safety concerns beyond those of regular eyeglasses. We still recommend protective sports eyewear when appropriate, just as we would for any child wearing glasses during athletic activities.
The trials enrolled children who were previously wearing regular glasses or had baseline measurements before starting treatment, so the results show what happens when children begin using Stellest. Research suggests that starting myopia control treatment can change the trajectory of progression compared to doing nothing, though individual responses vary.
Some Stellest trials were conducted primarily in Asian countries where myopia rates are high, while other studies included European populations. The treatment mechanism is based on optical principles that should apply across ethnicities, though progression rates and risk factors can vary by ancestry and environment. Generalizability beyond the trial populations studied remains an area of ongoing investigation.
The trials extending to three years did not identify harmful long-term effects on eye health from wearing Stellest lenses. Researchers monitored eye health at each visit and found that children maintained good ocular health throughout the study periods, though even longer-term follow-up data continues to emerge.
Getting Help for Evidence Summary: Stellest Clinical Trials at 1 to 3 Years
If you are considering Stellest lenses for your child or have questions about the clinical trial evidence, your eye care professional can review the research findings in the context of your child's specific situation and help you understand how this evidence applies to your family and guide you through the decision-making process for myopia management.