Essilor Stellest Lens Clinical Trial Results Published in JAMA Ophthalmology
Results from a 24-month U.S. clinical trial for Essilor Stellest lenses have been published in JAMA Ophthalmology, supporting their FDA De Novo market authorization.
EssilorLuxottica has announced the publication of 24-month results from a U.S. clinical trial evaluating Essilor Stellest lenses in JAMA Ophthalmology. The study, which supported the U.S. Food and Drug Administration's (FDA) De Novo marketing authorization, represents the first peer-reviewed publication of findings from this U.S. randomized trial for spectacle lenses designed to slow myopia progression in children.
The multicenter, double-masked, randomized clinical trial enrolled 159 myopic children aged 6–12 years across nine clinical sites. It assessed the safety and effectiveness of spectacle lenses featuring highly aspherical lenslets (HAL) compared to single vision lenses over a two-year period.
Key findings from the 24-month study indicated that Essilor Stellest lenses slowed myopia progression by an average of 71% (0.64D) over two years. The lenses also slowed axial elongation, the lengthening of the eyeball, by an average of 53% (0.24mm). The study found the lenses to have a well-tolerated safety profile and visual performance comparable to single vision lenses.
These findings align with previous international studies and extend the peer-reviewed evidence for this myopia management technology to a pediatric population in the United States. The publication is highlighted as an important milestone in the clinical evidence supporting Essilor Stellest lenses.