Clinical Report: Randomized Trial of HAL Spectacle Lenses for Myopia Control

Overview

The provided article describes a multicenter, double-masked randomized trial comparing highly aspherical lenslet (HAL) spectacle lenses with single-vision lenses in US children aged 6 to 12 years. The trial’s 36-month primary end point remains in progress; a prespecified 24-month analysis was conducted for regulatory purposes, but the supplied article excerpt does not report its numerical efficacy or safety results.

Background

Myopia prevalence is increasing globally, and the source estimates that approximately 50% of the world’s population may be myopic by 2050. Greater myopia severity is associated with higher risk of pathologic myopia, although most people with myopia do not develop pathologic myopia during their lifetimes. Available interventions described in the source include antimuscarinic eye drops, orthokeratology, and specially designed contact or spectacle lenses. HAL spectacles are designed to create myopic defocus anterior to the retina; prior Asian trials cited in the article reported efficacy, while the US trial was intended to assess outcomes in children in the United States.

Data Highlights

Key Findings

• The US trial randomized children aged 6 to 12 years to HAL or single-vision spectacle lenses at 9 investigational sites.
• Randomization was 1:1 and stratified by site, age category (6–8, 9–10, and 11–12 years), and baseline myopia category.
• The primary outcomes were changes from baseline in cycloplegic spherical equivalent refraction and axial length.
• The 36-month primary end point was still in progress; the article states that a prespecified 24-month analysis was undertaken for regulatory purposes.
• The supplied article excerpt does not provide the US trial’s 24-month numerical efficacy or safety findings.
• Prior studies cited in the article reported persistent HAL effects over 5 years in China and reduced myopia without rebound over 18 months in Vietnam.

Clinical Implications

The supplied excerpt establishes the US trial design and outcome measures but does not provide results sufficient to characterize the magnitude of benefit or safety at 24 months. The article identifies the ongoing 36-month primary end point as a further source of trial evidence; no treatment recommendation is stated in the supplied material.

Conclusion

This randomized US study was designed to compare HAL with single-vision spectacles for myopia progression in children, with refractive change and axial elongation as primary outcomes. Because the supplied excerpt omits the 24-month results and the 36-month end point remains in progress, it does not support a conclusion about the US trial’s treatment effect.

Related Resources & Content

1. Optometric Management, 2023 — Myopia Control Spectacles: Review of the Latest Research
2. Optometric Management, 2024 — MYOPIA: Reviewing proposed mechanisms for myopia spectacles
3. Optometric Management, 2026 — HAL Lenses Slow Myopia Progression Recommendations
4. International Myopia Institute, 2025 — Interventions for Controlling Myopia Onset and Progression
5. JAMA Ophthalmology, 2026 — Spectacle Lenses With Highly Aspherical Lenslets for Myopia Control: A Randomized Clinical Trial
6. JAMA Ophthalmology, 2022 — Spectacle Lenses With Aspherical Lenslets for Myopia Control vs Single-Vision Spectacle Lenses: A Randomized Clinical Trial
7. optometric management — Myopia: Spectacle Lens Use
8. International Myopia Institute—Interventions for Controlling Myopia Onset and Progression 2025
9. FDA De Novo authorization document DEN250016
10. Spectacle Lenses With Highly Aspherical Lenslets for Myopia Control: A Randomized Clinical Trial
11. Spectacle Lenses With Aspherical Lenslets for Myopia Control vs Single-Vision Spectacle Lenses: A Randomized Clinical Trial
12. IMI—Interventions for Controlling Myopia Onset and Progression 2025 - PMC
13. DEN250016.Letter.DENG.pdf
14. Spectacle Lenses With Highly Aspherical Lenslets for Myopia Control: A Randomized Clinical Trial | Trials | JAMA Ophthalmology | JAMA Network
15. Spectacle Lenses With Aspherical Lenslets for Myopia Control vs Single-Vision Spectacle Lenses: A Randomized Clinical Trial - PMC
16. Efficacy of spectacle lenses for myopia control: a meta-analysis of randomised controlled trials
17. Multifocal Soft Contact Lenses for the Treatment of Myopia Progression in Children - Ophthalmology
18. Efficacy and Safety of Different Atropine Regimens for the Treatment of Myopia in Children: Three-Year Results of the MOSAIC Randomized Clinical Trial | Trials | JAMA Ophthalmology | JAMA Network