Atropine, aspherical lenses enter trial for childhood myopia

New PEDIG trial tests options

According to an announcement from the National Eye Institute (NEI), the Pediatric Eye Disease Investigator Group (PEDIG) has launched a multicenter trial to test whether specialized spectacle lenses, atropine 0.05% eye drops, or a combination of the 2 can slow myopia progression in children.¹ The Myopia Treatment Study 2 (MTS2; NCT07095894) is enrolling children ages 5 to younger than 12 years at sites across the US.¹ Results could give optometrists new evidence-based options for slowing axial elongation in young patients.

Optometrists currently counsel families using myopia control data drawn largely from Asian pediatric populations, because neither intervention under study has been evaluated together in a US-based cohort.¹ A combination approach has also not been rigorously tested. Findings from MTS2 could clarify whether pairing an optical and a pharmacologic approach adds measurable benefit over either alone.

Trial design and primary aims

MTS2 will randomly assign approximately 348 children to receive specialized eyeglasses with HALT (highly aspherical lenslet target) MAX technology (Essilor International), atropine 0.05% eye drops (Imprimis Rx), or both.¹ Enrolled children will be followed for a 24-month treatment period, followed by 6 additional months of observation after treatment ends.¹ The trial is recruiting at 18 sites nationally and is funded by the NEI, with Essilor International providing lenses and financial support.¹

Spectacle lenses with HALT MAX technology have not received FDA clearance.¹ Investigators designed the extended observation period to help characterize any rebound in progression once treatment stops, a pattern documented with atropine in prior pediatric cohorts.

Prior evidence from abroad

The rationale for MTS2 draws on 2 separate lines of evidence generated outside the US. The LAMP study data showed that 0.05% atropine produced the greatest reduction in spherical equivalent progression and axial elongation among 3 tested concentrations in Hong Kong children.² Separately, findings from a randomized trial (ChiCTR1800017683) of spectacle lenses with highly aspherical lenslets showed that the lenses slowed myopia progression by roughly 0.80 D and axial elongation by 0.35 mm compared with single-vision lenses in Chinese children over 2 years of the trial.³

Neither trial enrolled a US population, and neither tested the 2 interventions in combination.²^,³ PEDIG investigators say this gap in evidence is part of the reason MTS2 was designed as a US-based, 3-arm comparison.

“Myopia is associated with a higher risk of serious eye diseases later in life, including retinal detachment, glaucoma, and myopic maculopathy,” Lori Ann Kehler, OD, associate professor at Vanderbilt University Medical Center and MTS2 co–lead investigator, said in a news release.¹ Katherine Lee, MD, PhD, of the University of British Columbia and the study’s other lead investigator, added that the trial “will help determine whether either of 2 therapies alone or the combination of both provides greater protection against progressive myopia in children in the United States.”¹

For practicing optometrists, MTS2 does not change current prescribing practices, as enrollment has only recently begun and results are years away.¹ The trial builds on PEDIG’s prior work establishing atropine dosing evidence in US children; data from an earlier PEDIG-led trial showed that 0.01% atropine did not outperform placebo in slowing myopia progression, underscoring why concentration matters and why 0.05% was selected for MTS2.⁴ ODs should continue monitoring myopic progression using current standard-of-care options while awaiting outcomes from this trial, and can direct interested families to clinicaltrials.gov for enrollment information.¹

References

1. NEI launches clinical trial testing therapies that slow childhood myopia progression. News release. National Eye Institute. June 25, 2026. Accessed July 15, 2026. https://www.nei.nih.gov/research-and-training/research-news/nei-launches-clinical-trial-testing-therapies-slow-childhood-myopia-progression

2. Yam JC, Jiang Y, Tang SM, et al. Low-concentration atropine for myopia progression (LAMP) study: a randomized, double-blinded, placebo-controlled trial of 0.05%, 0.025%, and 0.01% atropine eye drops in myopia control. Ophthalmology. 2019;126(1):113-124. doi:10.1016/j.ophtha.2018.05.029

3. Bao J, Huang Y, Li X, et al. Spectacle lenses with aspherical lenslets for myopia control vs single-vision spectacle lenses: a randomized clinical trial. JAMA Ophthalmol. 2022;140(5):472-478. doi:10.1001/jamaophthalmol.2022.0401

4. Repka MX, Weise KK, Chandler DL, et al; Pediatric Eye Disease Investigator Group. Low-dose 0.01% atropine eye drops vs placebo for myopia control: a randomized clinical trial. JAMA Ophthalmol. 2023;141(8):756-765. doi:10.1001/jamaophthalmol.2023.2855