Research
Research Digest: What 5+ Years of Defocus-Lens Data Means for Your Child
Parents reasonably ask: sure, the trials show two good years — but what happens over a whole childhood? We now have that answer.
The evidence chain, in one table
| Study stage | Design & size | Headline result |
|---|---|---|
| 2-year RCT | DIMS, 160 children, double-masked | 52% less myopia progression; 62% less axial elongation vs. single-vision |
| 3-year follow-up | DIMS cohort continued; original control group switched to DIMS | Control children slowed significantly after switching; benefit persisted in year 3 |
| 6-year follow-up | DIMS wearers followed to 6 years | Sustained control, no rebound after stopping, visual function within norms |
| 8–10-year follow-up | Original DIMS trial children into late adolescence | About 65% less cumulative axial elongation than modelled single-vision wear |
| 5-year RCT extension | HAL (Stellest), 43 children + extrapolated control | 1.75 D less progression, 0.72 mm less elongation over 5 years; high myopia 9% vs 38% |
| US pivotal trial | HAL (Stellest), 159 children, 9 US sites, 24 months | 71% less progression, 53% less elongation → FDA De Novo authorization, Sept 2025 |
Summarized from the peer-reviewed publications listed below. Percentages describe group averages — individual children respond differently, which is exactly why tracking matters.
Three things this means for your family
Starting early compounds
Five-year benefit was largest in children who started young and wore the lenses 10–12+ hours a day. Every diopter avoided in childhood is permanently avoided — the child who finishes at −2.00 D instead of −6.00 D carries a fraction of the lifetime retinal risk.
Consistency is the active ingredient
In the trials, full-time wearers got the strongest effect. The glasses only work while on the face — mornings off and "weekend breaks" dilute the dose. Make them the default, like a seatbelt.
"On treatment" is not the same as "controlled"
Even in trials, some children's eyes kept growing on defocus lenses. The studies prove the average works; only your child's own axial-length curve proves it is working for them. Measure every 3 months, same clinic, same device — and if the curve hasn't bent within a year, escalate the plan with your doctor.
Sources
Lam CSY et al., Br J Ophthalmol 2020 & 2022 (2-year RCT, 3-year follow-up; ClinicalTrials.gov NCT02206217) · Lam CSY et al., Scientific Reports 2023 (6-year) · Leung TW et al., BMJ Open Ophthalmology 2026 (8–10-year) · Li X et al., Eye and Vision 2025;12:10 (HAL 5-year) · Shen J et al., JAMA Ophthalmology 2026 (US pivotal trial, NCT05174780) · US FDA De Novo DEN250016, Sept 25, 2025.
The average works. Prove it works for your child.
Track the axial-length curve through any therapy and see your own data answer the question.
Evidence base for this page (defocus-lens trials and long-term follow-ups): #36 · #40 · #44 · #93 — full citations and DOI links in our Evidence Library.