Essilor Stellest lenses represent a significant advancement in spectacle-based myopia management, earning FDA authorization in September 2025 as the first eyeglass lenses specifically designed and authorized to slow myopia progression in children. This authorization followed rigorous clinical evaluation demonstrating both efficacy and safety in the pediatric population.
H.A.L.T. Technology: Mechanism of Action
Stellest lenses utilize Highly Aspherical Lenslet Target (H.A.L.T.) technology, incorporating 1,021 highly aspherical lenslets arranged in 11 concentric rings surrounding a clear central viewing zone. This optical design creates a volume of myopic defocus in front of the retina across the mid-peripheral visual field while maintaining clear central vision for distance and near tasks.
The theoretical basis rests on peripheral hyperopic defocus as a stimulus for axial elongation. By creating controlled myopic defocus anterior to the retina, H.A.L.T. technology provides a consistent signal to slow axial growth. The lenslet design differs from traditional peripheral defocus approaches by creating a more contiguous myopic signal across a larger portion of the visual field.
Primary Clinical Trial: Study Design and Methodology
The pivotal U.S. clinical trial supporting FDA authorization was a prospective, randomized, double-masked, controlled study conducted over two years. The study enrolled children aged 6 to 12 years at baseline with myopia and followed standardized inclusion and exclusion criteria.
Study parameters included:
Efficacy Outcomes: Refractive and Axial Length Data
The clinical trial demonstrated statistically significant and clinically meaningful reductions in both refractive progression and axial elongation compared to the control group wearing standard single-vision lenses.
Primary efficacy results at two years:
These results position Stellest among the most effective myopia control modalities currently available, with efficacy comparable to or exceeding other validated interventions including orthokeratology and multifocal soft contact lenses.
Axial Length as Primary Outcome Measure
While refractive progression has historically served as the primary outcome measure in myopia studies, axial length provides a more direct assessment of the structural changes underlying myopia and associated pathology risk. The 53% reduction in axial elongation represents meaningful protection against the stretching and thinning of ocular tissues that drive increased risk of retinal detachment, myopic maculopathy, and other sight-threatening complications.
Axial length and refractive error are closely correlated, with historically cited estimates suggesting each millimeter of axial elongation corresponds to approximately 1.6 diopters of myopic shift. However, this relationship varies by age, baseline refractive error, and individual ocular parameters, with pediatric studies showing variable correlations. Slowing axial growth directly reduces the physical stress on retinal and choroidal tissues, addressing the pathophysiological basis of myopia-related ocular disease rather than simply managing refractive error.
Comparative Efficacy: Position Among Validated Modalities
Stellest efficacy should be contextualized within the broader landscape of evidence-based myopia management interventions.
Comparative efficacy data from key studies:
- Stellest spectacle lenses: 71% refractive reduction, 53% axial reduction (2-year data)
- Orthokeratology: approximately 36% to 56% reduction in axial elongation (meta-analyses, highly variable depending on lens design parameters, back optic zone size, and patient factors)
- Low-dose atropine: 0.05% concentration shows approximately 64.5% reduction in spherical equivalent progression over 2 years, while 0.01% concentration shows significantly lower efficacy (concentration-dependent response)
- Diffusion Optics Technology (DOT) lenses: 59% reduction in spherical equivalent refractive progression and 38% reduction in axial elongation at 2 years in children who did not remove glasses for near work (CYPRESS study), with efficacy showing age-dependent variation.
Direct head-to-head comparisons are limited by differences in study populations, outcome measures, and follow-up durations. However, available evidence suggests that Stellest provides efficacy at the higher end of the validated intervention spectrum.
Safety Profile and Tolerability
The clinical trial demonstrated favorable safety and tolerability profiles comparable to standard single-vision spectacle correction.
Safety findings included:
The polycarbonate lens material provides superior impact resistance. Polycarbonate is widely used in pediatric eyewear due to its impact-resistant properties and is commonly specified for children’s safety eyewear. UV protection is inherent to the material, providing additional ocular protection.
Compliance and Real-World Effectiveness
Clinical trial efficacy data reflect controlled study conditions with high compliance monitoring. Real-world effectiveness depends critically on patient adherence to recommended wear time protocols.
The dose-response relationship between wear time and efficacy has been documented, with optimal outcomes achieved at 12 or more hours of daily wear. Clinicians should emphasize that efficacy is directly proportional to compliance, and strategies to maximize daily wear time should be integral to treatment protocols.
Compliance strategies supported by evidence include:
FDA Authorization: Regulatory Pathway and Implications
FDA authorization for Stellest lenses under the De Novo pathway represents a significant regulatory milestone for spectacle-based myopia management. This authorization establishes Stellest as a Class II medical device with specific indications for use in slowing myopia progression in children.
The De Novo classification provides:
Clinicians should note that FDA authorization language specifies that Stellest lenses “help slow the progression of myopia.” This phrasing reflects appropriate acknowledgment that treatment slows but does not halt progression, setting realistic expectations consistent with all current myopia management modalities.
Prescription Parameters and Patient Selection
FDA authorization specifies appropriate patient populations and prescription ranges for Stellest lens use.
Authorized parameters include:
Patient selection should consider not only prescription parameters but also lifestyle factors, compliance history, and individual progression risk. Rapid progressors, those with strong family history of high myopia, and children with limited outdoor time represent particularly appropriate candidates where intervention provides maximum risk reduction.
Fitting Considerations and Optical Alignment
Proper fitting and optical alignment are critical for optimal treatment efficacy with Stellest lenses. Unlike conventional single-vision spectacles where minor fitting variations have minimal impact, the peripheral optics design of Stellest requires greater precision.
Critical fitting parameters include:
Regular frame adjustment checks at follow-up visits ensure maintained alignment as children grow and facial anatomy changes. Improper fitting may reduce treatment efficacy by misaligning the lenslet zones relative to the pupil and visual axis.
Monitoring Protocols and Treatment Assessment
Evidence-based monitoring protocols optimize treatment outcomes and allow for timely intervention adjustments if progression continues despite treatment.
Recommended monitoring schedule includes:
Axial length provides the most direct assessment of treatment efficacy, measuring the structural changes that drive disease risk. Practices without axial length measurement capabilities should consider establishing access through referral relationships or equipment acquisition, as this technology is becoming standard of care in myopia management.
Combination Therapy Considerations
For children demonstrating inadequate response to monotherapy or those with particularly aggressive progression, combination approaches warrant consideration. While specific combination therapy data for Stellest is limited, theoretical rationale supports additive effects from simultaneous optical and pharmacological interventions.
Rational combination approaches include:
Combination therapy introduces additional complexity and cost. Risk-benefit analysis should weigh potential for enhanced efficacy against increased treatment burden and financial investment.
Integration with Environmental and Behavioral Interventions
Clinical evidence supports outdoor time as a protective factor against myopia onset and progression. While Stellest provides optical intervention, comprehensive management should incorporate lifestyle recommendations as complementary strategies.
Evidence-based lifestyle interventions include:
Clinicians should emphasize outdoor time as a prescription rather than suggestion, framing it as integral to treatment success comparable to medication adherence.
Cost-Effectiveness and Health Economics
Economic analysis of myopia management requires consideration of upfront treatment costs versus lifetime savings from reduced complications and decreased high myopia prevalence.
Health economic considerations include:
- Each diopter of myopia prevented significantly reduces the risk of vision-threatening complications, including myopic maculopathy and visual impairment. Research demonstrates that higher myopia levels are associated with increased risk of pathologic complications, making early intervention to slow progression clinically important.
- High myopia associated with substantially increased healthcare costs from retinal surgery, glaucoma management, and early cataract intervention
- Quality-of-life impacts of vision-threatening complications difficult to quantify but substantial
- Preventive intervention during childhood one-time opportunity to reduce lifetime disease burden
While formal cost-effectiveness analyses specific to Stellest are limited, modeling studies of myopia control interventions generally demonstrate favorable cost-effectiveness ratios when accounting for lifetime complications prevented.
Practice Integration and Patient Communication
Successful integration of Stellest into clinical practice requires structured protocols for patient identification, education, and ongoing management.
Recommended practice protocols include:
Patient education materials should avoid superlatives and guarantees, instead emphasizing evidence-based efficacy data and realistic outcomes. Appropriate messaging includes “clinically proven to slow myopia progression” and “helps reduce risk of complications” rather than “stops myopia” or “prevents all progression.”
Future Research Directions
While current evidence strongly supports Stellest efficacy and safety, ongoing research continues to refine understanding and optimize clinical applications.
Active areas of investigation include:
Clinical Implications and Recommendations
Stellest lenses represent an important addition to the myopia management armamentarium, providing spectacle-based intervention with efficacy comparable to contact lens and pharmacological approaches. The favorable safety profile, ease of use, and strong efficacy data support consideration of Stellest as a first-line option for appropriate candidates.
Key clinical recommendations include:
The FDA authorization of Stellest validates spectacle-based myopia control as a legitimate therapeutic approach and expands options for comprehensive pediatric myopia management. Clinicians should familiarize themselves with fitting protocols, efficacy data, and appropriate patient selection to optimize clinical outcomes and provide evidence-based care for this growing public health concern.
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References and Further Reading
Clinicians seeking additional detail on Stellest clinical research are encouraged to review the primary literature, FDA authorization documentation, and ongoing publications as evidence continues to evolve. Professional organizations including the American Academy of Optometry, American Academy of Ophthalmology, and specialty groups focused on myopia management provide continuing education resources and clinical practice guidelines.
The evidence base supporting myopia management continues to expand rapidly. Staying current with emerging research, attending professional education programs, and participating in clinical discussions ensures optimal patient care and incorporation of best practices as the field advances.
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