A study recently published in JAMA Ophthalmology outlined the findings from the randomized clinical trial (RCT) that served as the foundation for the recent FDA authorization of EssilorLuxottica’s Stellest lenses.
Let’s start with the Stellest lenses.
Originally designated as a Breakthrough Device in 2021, the Essilor Stellest lenses utilize the Highly Aspherical Lenslet Target (HALT) technology.
How this tech works:
- A total of 11 rings containing 1,021 small aspherical lenslets surround the central zone
- These lenslets then distribute light across a range in front of the retina (in lieu of focusing at a single point) to create a signal that slows axial elongation
- What this does: slows myopia progression and provides clear vision for everyday tasks
And when did the lenses receive authorization?
September 2025. As we reported, Essilor received FDA authorization to market the Stellest eyeglass lenses for the correction of myopia and to slow myopia progression in children 6-12 years of age at initiation of treatment.
So, to be clear, this newly-released data isn’t actually new per se, right?
Correct. The study’s 24-month results (which we’ll discuss in a moment), supported the lenses’ authorization.
Got it. Now, before we get to that, let's look at prior data.
Clinical trials in Asia have demonstrated the efficacy of highly aspherical lenslets (HAL) lenses, with a 5-year study in China showing a sustained treatment effect of 1.75 diopters (D) less myopia progression and 0.72 mm less axial elongation compared with control.
- To note: As safety and efficacy data on the Stellest lenses in U.S. children are lacking, this RCT sought to determine if the findings from the trials in Asia were generalizable to the broader population of North American children seeking myopia management in clinical practice.
Any others?
Last November, peer-reviewed research of an RCT in China (ChiCTR1800017683) evaluating the Stellest 2.0 lenses found that they resulted in a:
- 71% reduction in myopia progression (measured via spherical equivalent refraction [SER])
- 53% reduction in axial elongation (compared to a single-vision lens [SVL])
Alrighty, now to this foundational study.
The double-masked RCT (NCT05174780) sought to determine the effectiveness of HAL spectacle lenses compared with conventional SVLs in slowing myopia progression among U.S. children with myopia over a 2-year period.
- Main outcome measures: 24-month changes in cycloplegic SER (cSER) and axial length.
Some details:
- The trial took place at nine investigational sites in the United States
- The participants: 159 participants children aged 6 to 12 years (mean: 9.7 years) with a manifest SER of -0.75 to -4.50 D
- 80 (50.3%) male; 79 female
- 62.3% white
Tell me more about the design.
Participants were randomized 1:1 to HAL or SVL lenses, and stratified by three key characteristics:
- Site
- Age group (6-8, 9-10, and 11-12 years)
- Myopia subgroups (lower: –0.75 to –2.50 D manifest SER in the worst eye; higher: –2.75 to –4.50 D)
Key exclusion criteria included a history of:
- Prior myopia control intervention
- Strabismus
- Amblyopia
- Any ocular or systemic conditions
- Medications affecting refractive status
And when were patients enrolled?
Enrollment occurred from December 2021 to July 2022, and the 24-month follow-up reported here was completed in October 2024.
Note: Although the study remains ongoing toward its 36-month primary endpoint, this prespecified 24-month analysis was conducted to support regulatory submission.
Duly noted. So, what were the findings?
In general: With 135 (84.9%) participants completing the 24-month assessment, the HAL group demonstrated a significant reduction in myopia progression compared with the SVL group.
The baseline mean cSER was −2.21 D in the HAL group and −2.05 D in the SVL group.
- At 24 months: Adjusted mean myopia progression was −0.25 D in the HAL group and −0.90 D in the SVL group (0.64 D difference; 95% confidence interval [CI], 0.50 to 0.79; P < .001), a 71% relative reduction.
How did the lenses impact axial elongation?
The baseline mean axial length was 24.26 mm in the HAL group and 24.32 mm in the SVL group.
Adjusted mean axial elongation was 0.21 mm in the HAL group and 0.45 mm in the SVL group (difference, −0.24 mm; 95% CI, −0.29 to −0.19; P < .001), a 53% relative reduction.
At 24 months: 75.0% of eyes in the HAL group exhibited < 0.50 D change in cSER and 59.5% showed < 0.20 mm axial elongation, indicating slower refractive and structural progression than the control group.
Anything else to note?
Best-corrected visual acuity (BCVA) was equivalent between groups (mean difference, −0.01 logMAR; 95% CI, −0.02 to 0.00; P = 0.23).
Ocular adverse events occurred in 9 of 77 (11.7%) participants in the HAL group vs. 12 of 82 (14.6%) in the SVL group; none were serious or lens related.
- The total number of subjective symptom reports were 19 (HAL) and 25 (SVL).
Further: HAL lenses were well tolerated, with high compliance and strong retention rates (95% in HAL and 88% in SVL) in the RCT.
Next up: the experts’ opinion.
Prespecified analyses demonstrated that efficacy was independent of baseline refractive error, with comparable effects across severity subgroups.
- However: The treatment effect was most pronounced in participants aged 6 to 8 years, who achieved an 87% control effect and more than 1.00 D progression reduction.
“Given that younger children typically progress fastest and face the highest risk of high myopia, this observation highlights the clinical value of early intervention,” the study authors noted.
Any limitations?
A few, including:
- The 2-year duration was shorter than typical pediatric myopia control treatment, so 3-year and posttreatment data are still required to assess longer-term effectiveness
- The limited prescription range excluded high myopes, who warrant further investigation
- While the HAL lenslets were unobtrusive, unintentional unmasking could not be ruled out
And finally: the take home.
Aligned with previous international studies, these findings demonstrated that the Stellest lenses provided a significant reduction in myopia progression and axial elongation over 24 months in North American children with myopia aged 6-12 years.
While longer-term data are needed to evaluate sustained treatment efficacy, the data supported HAL as a safe and effective myopia control intervention.