Highly aspherical lenslets spectacle lenses slow myopia progression, study supports

Results from a randomized clinical trial indicate that spectacle lenses with highly aspherical lenslets (HAL) (Stellest, Essilor) reduce myopia progression by 71% compared with single-vision lenses in US children over 24 months. The double-masked trial (NCT05174780) enrolled 159 children aged 6 to 12 years and supported the FDA authorization of the study device, making the study the first of its kind to support said authorization. Additionally, the findings work to extend prior Asian efficacy data to a diverse North American cohort.^1,2

Published in JAMA Ophthalmology, the study was led by first author Jason Shen, PhD, of Essilor International in Dallas, Texas.

“Given the diversity of the participants recruited across 9 US investigational sites, these findings are likely generalizable to the broader population of North American children seeking myopia management in clinical practice,” the study authors stated. “Although the primary end point of the protocol is at 36 months, these 24-month data were analyzed to support regulatory submission, using a penalized α threshold to maintain the integrity of the ongoing trial.”

For ODs building myopia management panels, the trial addresses a long-standing evidence gap. Until recently, no myopia control spectacle lens held US marketing authorization, leaving practitioners reliant on off-label atropine, orthokeratology, and dual-focus contact lenses, according to the study authors. HAL spectacle lenses could now give optometrists a noninvasive fitting option with US trial support across a broad pediatric age and severity range.

Trial design and primary myopia progression results

The double-masked trial randomized 159 children 1:1 to HAL or single-vision lenses across 9 US investigational sites, stratified by site, age, and baseline myopia. Eligible children were aged 6 to 12 years with a manifest spherical equivalent refraction of −0.75 to −4.50 D and astigmatism no greater than 1.50 D. Coprimary outcomes were 24-month changes in cycloplegic spherical equivalent refraction (cSER) and axial length, and 135 of 159 participants (84.9%) completed the assessment.¹

At 24 months, adjusted mean myopia progression was −0.25 D with HAL versus −0.90 D with single-vision lenses, a difference of 0.64 D (95% CI, 0.50 to 0.79; P < .001) and a 71% relative reduction. Axial elongation measured 0.21 mm with HAL versus 0.45 mm with control, a difference of −0.24 mm (95% CI, −0.29 to −0.19; P < .001) and a 53% relative reduction. Efficacy was consistent across baseline severity subgroups and most pronounced in children aged 6 to 8 years, who showed an 87% relative reduction.¹

Visual acuity, safety, and tolerability findings

Best-corrected distance visual acuity was equivalent between groups at 24 months, with a mean difference of −0.01 logMAR (95% CI, −0.02 to 0.00; P = .23), meeting the prespecified equivalence margin. No participant in either group lost more than one line of best-corrected acuity from baseline.¹ Mean daily wear time exceeded 12 hours in both groups, indicating strong compliance with the spectacle intervention.¹

Safety findings were reassuring for a pediatric population. Ocular adverse events occurred in nine of 77 HAL participants (11.7%) versus 12 of 82 control participants (14.6%), and none were serious or lens related. Subjective symptom reports were similar between groups, with blurred distance or general vision the most common complaint. Retention was high, at 95% in the HAL group and 88% in the control group, and reported withdrawals were not treatment related.¹

“In conclusion, the findings of this US-based randomized clinical trial support the safety and effectiveness of HAL lenses for reducing the progression of myopia in children aged 6 to 12 years. These data align with previous international studies, supporting the effectiveness of this technology in a US cohort,” the study authors stated.

Practitioners should note the trial excluded high myopes above −4.50 D, and 36-month and posttreatment data are still needed to assess durability and rebound.¹

References

1. Shen J, Hunt C, Graeme Young G, Drobe B. Spectacle lenses with highly aspherical lenslets for myopia control: Randomized clinical trial. JAMA Ophthalmology. 2026. doi:10.1001/jamaophthalmol.2026.3288

2. 24-month US clinical trial results supporting FDA De Novo Market Authorization of Essilor Stellest lenses published in JAMA Ophthalmology. News release. EssilorLuxottica. August 27, 2026. Accessed August 28, 2026.