TOPLINE

Spectacle lenses with highly aspherical lenslets (HAL) reduced myopia progression by more than 70% and axial elongation by more than 50% compared with single-vision lenses (SVL) in children aged 6 to 12 years over 24 months.

METHODOLOGY

• A randomized double-masked controlled clinical trial enrolled 159 children aged 6 to 12 years with myopia ranging from −0.75 diopters (D) to −4.50 D across 9 US sites; participants were randomly assigned to wear spectacles with HAL (n = 77) or SVL (n = 82) for 24 months.
• Among the participants, 84.9% completed the 2-year follow-up.
• Primary outcomes were changes in cycloplegic spherical equivalent refraction (cSER) and axial length at 24 months; cSER was measured annually by cycloplegic autorefraction and axial length was measured every 6 months by partial coherence interferometry.
• Cycloplegia was induced with 0.5% proparacaine or 0.4% benoxinate, followed by 2 drops of 1% tropicamide administered 5 minutes apart, with measurements performed 25 minutes after the final drop.
• Safety was assessed through tracking of ocular and nonocular adverse events (AEs), measurement of best-corrected visual acuity in each eye individually, and monitoring of any symptoms, issues, or complaints reported by participants.

TAKEAWAY

• At 24 months, the mean change in cSER was −0.25 D in the HAL group vs −0.90 D in the SVL group — a difference of 0.64 D (P <.001), and a 71% relative reduction.
• Axial length increased by 0.21 mm in the HAL group vs 0.45 mm in the SVL group, with a treatment difference of −0.24 mm (P <.001), and a 53% relative reduction.
• Subgroup analyses showed consistent treatment effects across age groups and baseline myopia severity levels, with no significant interactions (P >.05 for all comparisons).
• Distance best-corrected visual acuity was comparable between groups at 24 months; although, 21 ocular and 67 nonocular AEs occurred across both groups, none were considered related to the test lenses except one possibly device-related headache in the SVL group.

IN PRACTICE

"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 authors wrote.

“Longer follow-up is needed to determine whether benefits persist after treatment discontinuation, and whether children continue to tolerate and wear the lenses consistently over time,” experts wrote in an invited commentary.

SOURCE

The study was led by Jason Shen, PhD, Essilor International in Dallas. It was published online on August 20 in JAMA Ophthalmology.

LIMITATIONS

The 24-month duration is shorter than typical pediatric myopia control treatment, and 3-year data are needed to assess longer-term effectiveness. The limited prescription range excluded children with high myopia, who warrant further investigation. Although the HAL lenslets are unobtrusive under normal viewing conditions, unintentional unmasking cannot be ruled out.

DISCLOSURES

The study was funded by Essilor International. Two authors are employees of Essilor International (an affiliate of EssilorLuxottica), and one author reported holding patents pending related to the technology. Two authors are employees of Visioncare Research, and one of them received grants from Visioncare Research during the study.

This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication.