Spectacle lenses with highly aspherical lenslets reduced myopia progression and axial elongation over 24 months compared with conventional single-vision spectacle lenses in US children who had myopia, according to results of a randomized clinical trial published in JAMA Ophthalmology.

The double-masked trial was conducted at 9 US investigational sites and included children aged 6 to 12 years with a manifest spherical equivalent refraction (SER) of −0.75 D to −4.50 D. Children who had prior myopia control interventions, strabismus, amblyopia, or any ocular or systemic conditions or medications affecting refractive status were excluded. Participants were randomized 1:1 to spectacle lenses that had highly aspherical lenslets (HAL) or single-vision spectacle lenses (SVL), with randomization stratified by site, age group, and baseline myopia. Participants, their parents or guardians, and selected investigators were masked to the lens assignment. Enrollment was from December 2021 to July 2022, and the 24-month follow-up reported here was completed in October 2024.

Coprimary outcomes were 24-month changes in cycloplegic SER (cSER) and axial length. cSER was measured annually by cycloplegic autorefraction, and axial length was measured every 6 months by partial coherence interferometry. Participants were instructed to wear the study spectacles for at least 10 hours per day, 6 days per week. Other prespecified outcomes included subgroup analyses of treatment effect by baseline age and baseline myopia severity. 

The intention-to-treat population included 159 participants, of whom 77 were assigned to HAL and 82 to SVL; 135 (85%) completed the 24-month follow-up. Mean age was 9.7 years, and 50% of participants were male. At baseline, mean cSER was −2.21 D in the HAL group and −2.05 D in the SVL group, while mean axial length was 24.26 mm in the HAL group and 24.32 mm in the SVL group.

At 24 months, adjusted mean myopia progression was −0.25 D with HAL compared with −0.90 D with SVL, a difference of 0.64 D and a 71% relative reduction in progression. Adjusted mean axial elongation was 0.21 mm with HAL vs 0.45 mm with SVL, a difference of 0.24 mm and a 53% relative reduction.

Effects Across Age and Myopia Severity

Prespecified subgroup analyses showed consistent treatment effects across age groups and baseline refractive error. The largest refractive treatment effect occurred among children aged 6 to 8 years, with a 1.03 D difference between groups, corresponding to an 87% relative reduction in myopia progression.

Differences were 0.54 D among children aged 9 to 10 years and 0.55 D among those aged 11 to 12 years, corresponding to relative reductions of 63% and 75%, respectively. Reductions in axial elongation across the 3 age groups were 0.36 mm, 0.25 mm, and 0.18 mm.

Treatment effects also did not substantially differ according to baseline myopia severity, although the investigators noted that the study was not powered to definitively assess effect modification. Compared with SVL, HAL reduced 24-month myopia progression by 0.57 D among children in the lower baseline myopia group and by 0.76 D among those in the higher baseline myopia group.

In an analysis of the proportion of eyes meeting progression thresholds, 75% of eyes treated with HAL had less than 0.50 D of myopia progression at 24 months compared with 36% of control eyes. In addition, 57% of HAL-treated eyes had less than 0.20 mm of axial length change compared with 16% of control eyes.

Safety and Tolerability

Distance best-corrected visual acuity (BCVA) was equivalent between groups at 24 months, and no participants in either group showed an apparent worsening of BCVA of more than 1 line from baseline. Participants reported 19 symptoms over 2 years in the HAL group and 25 in the SVL group, most commonly blurred distance or general vision.

Ocular adverse events occurred in 9 of 77 participants (12%) assigned to HAL and 12 of 82 (15%) assigned to SVL. No adverse events were considered related to the HAL lenses, and no serious or lens-related adverse events were reported. Mean daily spectacle wear exceeded 12 hours in both groups throughout follow-up.

Study Limitations

The investigators noted that the 2-year follow-up was shorter than the typical duration of pediatric myopia control treatment; the trial remains ongoing toward its 36-month primary endpoint, and longer-term and posttreatment data are needed to assess sustained effectiveness. The study's prescription range also excluded children who have high myopia. In addition, although the HAL lenslets were designed to be unobtrusive, the investigators said unintentional unmasking cannot be ruled out.

The investigators also noted that the clinical relevance of the magnitude of the decreased progression of spherical equivalent and axial length with the intervention through adulthood is unknown, and that further follow-up is needed to determine whether these differences result in longer-term reduction of the risk for myopia-related ocular pathologies.

“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,” the investigators wrote. OM

Disclosures: The study was sponsored by Essilor International, which was involved in the design and conduct of the study; collection, management, analysis, and interpretation of the data; preparation, review, or approval of the manuscript; and decision to submit the manuscript for publication.

Jason Shen, PhD, and Björn Drobe, PhD, reported employment with Essilor International, an EssilorLuxottica affiliate; Drobe also reported pending patents. Chris Hunt, MSc, reported employment with Visioncare Research. Graeme Young, PhD, reported employment with and grants from Visioncare Research. No other disclosures were reported.