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.

Myopia-control spectacle lenses are no longer a promising experiment — they are a proven, durable therapy. The two big defocus designs (DIMS and HAL/Stellest) now have published follow-up of 5, 6 and even 8–10 years: the slowing effect persists for as long as the lenses are worn, shows no rebound when stopped, and in the 5-year HAL study, cut the rate of children crossing into high myopia from 38% to 9%. In September 2025 the design gained FDA authorization in the US.

The evidence chain, in one table

Study stageDesign & sizeHeadline result
2-year RCTDIMS, 160 children, double-masked52% less myopia progression; 62% less axial elongation vs. single-vision
3-year follow-upDIMS cohort continued; original control group switched to DIMSControl children slowed significantly after switching; benefit persisted in year 3
6-year follow-upDIMS wearers followed to 6 yearsSustained control, no rebound after stopping, visual function within norms
8–10-year follow-upOriginal DIMS trial children into late adolescenceAbout 65% less cumulative axial elongation than modelled single-vision wear
5-year RCT extensionHAL (Stellest), 43 children + extrapolated control1.75 D less progression, 0.72 mm less elongation over 5 years; high myopia 9% vs 38%
US pivotal trialHAL (Stellest), 159 children, 9 US sites, 24 months71% 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

1

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.

2

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.

3

"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.

Research digest, not medical advice. Study averages describe groups, not your child. Treatment choices belong to you and your eye-care professional.

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.

By · 25 years in children's myopia prevention, creator of the 6S Method · This page is educational content, not medical advice.