What is available in the US
Low-dose atropine
Myopia-control spectacles
- Stellest (EssilorLuxottica): Features Highly Aspherical Lenslet Target (HALT) technology. FDA market authorized for myopia control in children ages 6 to 12 and the only myopia-control spectacle lens available in the US.
- The pivotal trial enrolled children ages 8 to 13 with spherical equivalent refraction (SER) of −0.75 to −4.75D and astigmatism ≤1.50D, so the efficacy data come from a slightly older cohort than the authorized range.4
- Not available in the US: MiyoSmart (Hoya, DIMS), MyoCare (Zeiss, CARE), and SightGlass Vision (DOT), all of which have published clinical data.5,6,7
Specialty contact lenses:
- MiSight 1 Day (CooperVision): Dual-focus daily disposable with +2.00D concentric defocus zones. The pivotal trial enrolled contact-lens-naïve children with SER of −0.75 to −4.00D and astigmatism <1.00D.8 FDA-approved in 2019 as the first soft contact lens indicated to slow myopia progression in children ages 8 to 12 at initiation of treatment.9
- NaturalVue Multifocal (VTI): Extended-depth-of-focus (EDOF) daily disposable, FDA-cleared as a multifocal, used off-label for myopia control.10
- Biofinity Multifocal D and Proclear Multifocal D: Center-distance designs with a +2.50D add, used off-label. Center-near designs produce the opposite peripheral effect and should be avoided.11,12
- Orthokeratology (ortho-K): Overnight rigid GP lenses that reshape the cornea, giving spectacle-free daytime vision and peripheral myopic defocus. Used off-label for myopia control.
Atropine: What the evidence shows
- 0.01%: 0.291D of SER slowing at 1 year, 0.174 D at 2 years13
- 0.05%: 0.520D of slowing13
- 0.04% vs. 0.01%: 0.18mm less axial growth in a 2025 JAMA Ophthalmology RCT, but photophobia in 22.9% vs. 2.1%14
- Pupil size: In CHAMP-UK, pupil diameter was the only secondary outcome that differed, at 0.36mm greater with 0.01%. No serious adverse events were drug-related.15
- Photophobia and blurred vision: The adverse events most plausibly drug-related in North American CHAMP.16
- Accommodation: A 2026 meta-analysis of 13 RCTs found a small reduction at 0.01% (−0.84D) with substantial heterogeneity and no consistent effect at individual time points, versus a consistent and clinically meaningful −1.96D at 0.05%.20
Practical step: Check accommodative amplitude at follow-up, particularly when moving above 0.01% or when a child reports near symptoms.
Stopping atropine: Rebound and tapering
- Reassuring: In MOSAIC year 3, children who stopped 0.01% progressed at −0.23D and 0.14mm per year, no faster than placebo.22 CHAMP year-4 data agree, with a 0.019D difference between stoppers and continuers (P = 0.82).23
- Cautionary: In LAMP at 3 years, continued treatment beat washout at every concentration, with rebound smaller in older children and at lower concentrations.18 At 5 years, 87.9% of the cessation arm eventually required re-treatment.19
- Restarting works: PRN restart with 0.05% matched uninterrupted therapy from years 3 to 5 (SER −1.00D vs. −0.97D, P = 0.55).19
- Cumulative 5-year progression on continued treatment:19
- 0.05%: −1.34D
- 0.025%: −1.97D
- 0.01%: −2.34D
Bottom line: Dramatic rebound at 0.01% is uncommon, most children need treatment again, and restarting works.
Spectacles: What the evidence shows
- Stellest: 55% SER and 51% axial reduction in its 2-year pivotal RCT, with full-time wear of at least 12 hours daily outperforming part-time wear.4 A cross-over trial confirmed no rebound after discontinuation.27
- MiyoSmart: The 6-year extension is one of the longest myopia-control datasets published. Children who wore DIMS lenses throughout progressed just −0.92D with 0.60mm of axial elongation, and the control effect held steady rather than fading, with no rebound after cessation.5,28
- Head-to-head: A 1-year double-masked RCT of 120 Indian children found DIMS and HALT comparable (56.7% and 58.1%), both outperforming CARE (47%).29
- CARE, for international context: 0.21D less SER progression and 0.14mm less axial elongation at 12 months in the European CEME trial, and a 0.44D difference in a 2-year Chinese trial.6,30
Bottom line: Wear time is the variable most under a clinician's influence. Set the 12-hour expectation at dispensing.
Contact lenses: What the evidence shows
- MiSight: 0.73D (59%) less progression and 0.32mm (52%) less axial elongation over 3 years in 144 children ages 8 to 12, with 6-year data confirming durability.8,31
- The 2025 American Academy of Ophthalmology technology assessment reviewed 12 studies, 11 rated level I, and reported control effects of 69%, 59%, and 59% at 12, 24, and 36 months.9
- NaturalVue: 0.84D of slowing, roughly 85%, in a retrospective study of 196 patients. The absence of a concurrent control group warrants caution.10
- Biofinity D, +2.50 D add: 0.45 D (43%) and 0.23 mm (36%) less progression over 3 years in BLINK. Medium add was not effective.11
Choosing the right option for myopia control
- Axial length above the 75th percentile for age
- Progression ≥0.50 D/year or ≥0.30 mm/year
- Onset before age 8
- Two myopic parents
- Minimal outdoor time
Match modality to age
- Ages 6 to 8, if not ready for contacts: Atropine or Stellest.
- Age 8 and up: MiSight, NaturalVue, off-label multifocals, and ortho-K all become viable. Younger age at ortho-K initiation and larger pupils predict greater effect.33,34
- Older adolescents: In the 2-year Xu trial (ages 8 to 15), 0.04% atropine slowed axial growth more than ortho-K or 0.01% atropine, though at the cost of more photophobia.14 In practice, a single lens-based modality—a soft myopia-control lens or ortho-K—is often the more practical choice for this age group, since it corrects vision and slows progression at once.
- Atropine monotherapy still requires separate optical correction, so higher-concentration atropine is better reserved for cases needing added control or used as an adjunct.14,25
Know the contraindications
- High myopia (SER beyond roughly −6.00D, which exceeds the FDA-approved correction range of the Euclid and Paragon CRT designs and leaves residual refractive error as central flattening plateaus)
- High astigmatism (corneal astigmatism above roughly 1.50D, which exceeds the FDA-approved range and predicts lens decentration)
- Extreme corneal curvatures (flat K outside about 41 to 45D)
- Poor lens hygiene
Address lifestyle in every visit
Combination therapy for fast progressors
- Atropine plus ortho-K: A 2-year age-stratified RCT of 164 children found the combination outperformed either monotherapy for axial elongation, though the advantage narrowed within age subgroups.34
- Atropine plus DIMS: In ASPECT, 0.025% atropine plus DIMS produced 0.11mm less axial growth at 12 months than atropine alone, with 39.6% showing no axial elongation versus 12.2%.38 A European observational study of 146 children reached the same conclusion.39
A practical sequence: Start monotherapy, reassess axial length every 6 months, then add a complementary modality or increase atropine concentration if progression exceeds 0.30mm/year.
Sample scripts for talking to parents about myopia
Key takeaways
- Myopia management is essential for progressive pediatric myopia, as every diopter increases lifetime complication risk.
- Two FDA-authorized options anchor U.S. treatment: MiSight 1 day, approved in 2019 for ages 8 to 12 at initiation, and Stellest, market authorized for ages 6 to 12. NaturalVue, center-distance multifocals, ortho-K, and compounded low-dose atropine are used off-label.9,39
- Axial length is the cornerstone metric. Measure at baseline and every 6 months.
- Atropine efficacy is concentration-dependent. While 0.01% has shown benefit in both Asian and predominantly white cohorts, 0.05% is the more effective concentration and, in LAMP, delivered the highest efficacy of the low doses tested while remaining well tolerated.13,15
- Atropine side effects also rise with concentration. Mydriasis and reduced accommodative amplitude are modest at 0.01% but clinically meaningful at 0.05%, so monitor near function as the dose rises.15,18
- Plan for cessation. Dramatic rebound at 0.01% is uncommon, but 87.9% of LAMP children needed to restart, PRN re-treatment matched continuous therapy, and tapering may reduce rebound.20,23,24
- Center-distance designs are essential; center-near designs worsen peripheral defocus.12
- Ortho-K effect declines over time and rebound can follow discontinuation.25,32,33
- Combination therapy benefits fast progressors, strongest for atropine plus ortho-K and atropine plus DIMS.2,34,37,38
- Recommend 80 to 120 minutes of daily outdoor time for all children.35,36
