EssilorLuxottica announced the publication of 24-month results from the U.S. clinical trial of Essilor Stellest spectacle lenses. The randomized clinical trial supported the FDA’s De Novo marketing authorization of Stellest lenses, the first FDA-authorized spectacle lenses to slow myopia progression in children.
Myopia Progression Slowed Over Two Years
The multicenter, double-masked trial included 159 children ages 6 to 12 at nine U.S. sites. Participants were randomized to receive spectacle lenses with highly aspherical lenslets (HAL) or conventional single-vision lenses. The study evaluated changes in cycloplegic spherical equivalent refraction and axial length over 24 months. Participants in both groups averaged more than 12 hours of daily lens wear throughout the study.
At 24 months, average myopia progression was -0.25 D among children wearing HAL lenses compared with -0.90 D in the single-vision group, a 71% relative reduction. Average axial elongation was 0.21 mm in the HAL group compared with 0.45 mm in the control group, a difference of 0.24 mm (53% relative reduction).
The researchers also found that treatment effects were consistent across age and baseline myopia groups. The largest effect was observed among children ages 6 to 8, who had a 1.03 D difference in myopia progression compared with the control group.
“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 researchers said.
Safety and Long-Term Follow-Up
Best-corrected visual acuity at 24 months was equivalent between the two groups, and no serious or lens-related adverse events were reported.
The researchers noted that longer-term follow-up is needed to determine whether the reductions in myopia progression and axial elongation translate into a lower risk of myopia-related ocular disease later in life. The trial’s primary endpoint is at 36 months—the 24-month analysis was conducted for regulatory purposes.