HAL myopia-control spectacles in Western children: what the US randomised trial adds

Spectacle lenses with highly aspherical lenslets (HAL, sold as Essilor Stellest) have supportive trial data from China and Vietnam, but families in Hamilton often ask: does it work in children like mine? A randomised trial published in JAMA Ophthalmology in August 2026 (Shen et al.) is the first to test HAL against single-vision spectacles in a multicentre United States cohort. It is a useful addition, with features that deserve a measured reading.

What was done

This was a double-masked, randomised trial at 9 US sites. Children aged 6 to 12 years with manifest myopia between −0.75 and −4.50 D and astigmatism no more than 1.50 D were randomised 1:1 to HAL lenses or single-vision lenses (SVL), stratified by site, age band and baseline myopia. Children with prior myopia control, strabismus or amblyopia were excluded. Families were asked for at least 10 hours of wear per day, 6 days a week.

The co-primary outcomes were the 2-year change in cycloplegic spherical equivalent refraction (cSER) and in axial length, measured by a masked technician after the child had removed the study spectacles. Refraction is what parents see on the prescription; axial length is the structural change that drives long-term risk.

The trial's actual primary end point is at 36 months and the study is still running. What has been published is a prespecified 24-month interim analysis conducted, in the authors' words, "for regulatory purposes", with the significance threshold at 24 months set at P < .009 rather than the usual .05.

Who was enrolled

Of 175 children assessed, 159 were randomised (77 HAL, 82 SVL) and all 159 were included in the intention-to-treat analysis. Mean age was 9.7 (SD 1.6) years; 50.3% were male. Parent-reported race was 62.3% White with HAL and 63.4% with SVL, with roughly a fifth Black or African American and a fifth East or Southeast Asian in each arm. Baseline cSER was −2.21 (SD 1.07) D with HAL and −2.05 (1.22) D with SVL; baseline axial length was 24.26 (0.92) mm and 24.32 (0.83) mm respectively.

What was found at 24 months

Adjusted mean myopia progression was −0.25 (SE 0.05) D with HAL versus −0.90 (0.05) D with SVL. The between-group difference was 0.64 D (95% CI 0.50 to 0.79; P < .001), reported as a 71% relative reduction.

Adjusted axial elongation was 0.21 (0.02) mm with HAL versus 0.45 (0.02) mm with SVL, a difference of −0.24 mm (95% CI −0.29 to −0.19; P < .001), reported as a 53% relative reduction.

For readers new to these statistics: a 95% confidence interval is the range within which the true average difference would plausibly lie if the study were repeated many times; here, even the least favourable end of each interval (0.50 D, 0.19 mm) still favours HAL. The P value is the probability of seeing a difference at least this large if the lenses truly made no difference; P < .001 means chance alone is a very unlikely explanation.

Sensitivity analyses were reported as confirming the primary result. In prespecified subgroups the refractive effect was largest in 6- to 8-year-olds (1.03 D; 95% CI 0.73 to 1.33) and similar in lower (0.57 D) and higher (0.76 D) baseline myopia, although the study was not powered for these comparisons.

Best-corrected acuity was equivalent at 24 months (mean difference −0.01 logMAR; 95% CI −0.02 to 0.00). Ocular adverse events occurred in 9 of 77 HAL participants (11.7%) and 12 of 82 SVL participants (14.6%); none were judged serious or lens-related. Symptom reports totalled 19 with HAL and 25 with SVL.

Why the percentages need context

A 71% reduction is a striking headline, but a relative reduction is a ratio whose denominator is the control group's progression. Here the SVL children progressed −0.90 D and 0.45 mm over 2 years. In a cohort progressing more slowly, the same 0.64 D and 0.24 mm absolute effect would be a smaller percentage; in a faster cohort, a larger one. We encourage families to think in dioptres and millimetres when comparing this trial with the LAMP low-dose atropine data or the red-light therapy trials, each of which had its own control-group progression rate.

The refractive percentage (71%) also exceeds the axial percentage (53%); the authors estimate that eyes with stable refraction still elongated 0.12 mm (HAL) to 0.21 mm (SVL), a reminder that axial length is the more conservative yardstick.

Limitations of this evidence

• Sponsor authorship. The first and senior authors are affiliated with Essilor International, the lens manufacturer, and the other two are from a contract research organisation. The analysis was prepared to support a US Food and Drug Administration submission. That does not invalidate a randomised trial, but the authors' suggestion that HAL "offers superior or comparable effectiveness" to other treatments is interpretation; no other intervention was tested.
• Interim, not final. These are 24-month data from a 36-month trial. Whether the effect persists in the third year, and what happens after the lenses are stopped, is unknown.
• Uneven attrition. 135 of 159 (84.9%) completed 2 years, but discontinuation was 9.1% with HAL and 19.5% with SVL. Imputation and sensitivity analyses address this, yet observed 24-month data rest on 69 versus 66 children.
• Masking and range. The lenslet rings can be seen at certain angles by a trained observer, and the authors concede unintentional unmasking cannot be ruled out. Children above −4.50 D were excluded, and wear time was self-reported.
• Small internal inconsistency. The proportion of HAL eyes with under 0.20 mm elongation is given as 56.6% in the results and 59.5% in the discussion; minor, but we could not resolve it from the published text.
• Clinical relevance. As the authors state, whether a 0.24 mm difference in eye length in childhood translates into fewer myopia-related eye diseases in adulthood is not yet known.

What this means for families in Hamilton

In an ethnically mixed Western cohort, HAL lenses slowed both refractive and axial progression over 2 years. For a child aged 6 to 12 with low to moderate myopia who prefers glasses to drops or contact lenses, this strengthens the case for such a lens as one option, alongside outdoor time and regular cycloplegic and axial length monitoring. The optometrist team at Rose Optometry (Jagrut Lallu, Jacqueline Rowe and colleagues) measures axial length as standard in the myopia control service, so progress is judged in millimetres rather than prescription change alone. Parents who would like to talk through the options can book a free Myopia Chat with Jagrut.

Jagrut Lallu — BOptom (Hons), MSc Specialty Lenses (Hons), FIAOMC. Therapeutic Optometrist & Contact Lens Specialist. Founder, New Zealand Eye Research Centre; Partner, Rose Optometry; WCO Asia-Pacific Myopia Ambassador; International Myopia Institute NZ Ambassador; Clinical Senior Lecturer, Deakin School of Optometry; Honorary Teaching Fellow, University of Auckland.

Reference

• Shen J et al. Spectacle Lenses With Highly Aspherical Lenslets for Myopia Control: A Randomized Clinical Trial. JAMA Ophthalmol. 2026; published online August 20 (volume/issue/pages not yet assigned). PMID 42623028. https://doi.org/10.1001/jamaophthalmol.2026.3288