A randomized, controlled trial published in the British Journal of Ophthalmology has shown that a combination of 0.025% atropine eye drops and defocus incorporated multiple segments (DIMS) spectacle lenses is more effective in slowing axial elongation in children who have myopia than atropine paired with standard single vision (SV) lenses. The 12-month study, known as the ASPECT trial, is the first of its kind to evaluate this combination therapy in a European pediatric population.

The study enrolled 111 children aged 4 to 16 years with myopia ranging from −1.00 D to −6.00 D and up to 2.00 D of astigmatism. Participants were randomly assigned to two groups:

• Group A: 0.025% atropine + SV lenses (n=49 completed)

• Group B: 0.025% atropine + DIMS lenses (n=53 completed)

Both groups received nightly atropine eye drops and customized lenses. Follow-up assessments were conducted at baseline, 6 months, and 12 months. Only right eye data were used for statistical analysis to maintain consistency.

Primary Outcomes: Axial Length and Refractive Error

The atropine/ DIMS lenses combination therapy slowed axial elongation by 61.1% and myopia progression by 54.7% compared with monotherapy. The treatment was well tolerated, with few adverse events. There was only one dropout due to atropine side effects.

• Axial Length (AL) Outcomes:

  • Mean 12-month increase:

    • Group A: 0.18 ± 0.16 mm

    • Group B: 0.07 ± 0.16 mm

    • Mean difference: 0.11 mm (95% confidence interval [CI] = 0.05–0.17, P≤.001)

  • No axial elongation was observed in 39.6% of children in Group B, compared with 12.2% in Group A (P=.002).

  • Using the Age-Matched Myopia Control system, the researchers found that Group B's axial elongation closely matched physiological growth rates for emmetropic children, particularly in younger age groups. “This suggests that combined therapy is a promising management strategy, especially for younger children with increased AL,” the authors noted.

  • Compared with prior monotherapy studies in Asian and European populations, the combination therapy in the ASPECT trial achieved superior control of axial elongation.

• Spherical Equivalent Refraction (SER) Outcomes:

  • 12-month progression:

    • Group A: −0.19 ± 0.42 D

    • Group B: −0.09 ± 0.35 D

    • Difference not statistically significant (P=.13)

Subgroup Analyses and Predictors of Progression

Multivariate analyses identified the following:

• Children aged 11 to 15 years had less axial elongation (β = −0.094, P=.025).

• Group B showed significantly reduced AL progression (β = −0.100, P=.004).

• Parental myopia was associated with faster SER progression in univariate analysis (β = −0.297, P=.003), but was not significant in multivariate models.

• There was no significant interaction between ethnicity and treatment outcomes.

The researchers compared these results to the landmark LAMP study in which 0.025% atropine alone yielded a 12-month AL increase of 0.29 ± 0.20 mm and SER change of −0.46 ± 0.45 D. This results of the ASPECT trial suggest a potential additive or synergistic effect.

The authors proposed that the additive efficacy may stem from atropine-induced pupil dilation that enhances the myopic defocus effect of DIMS lenses, much like hypotheses regarding the mechanism in atropine and orthokeratology combination therapy. While no direct correlation was found between pupil size and treatment outcomes, 39.6% of Group B achieved zero axial elongation over 12 months—a considerably higher rate than those previously reported with monotherapy.

As the ASPECT trial progresses to its 24-month endpoint, long-term effectiveness and sustainability of combined therapy will be further evaluated.

A full list of author disclosures can be found in the published research.