Combining DIMS spectacle lenses with atropine 0.01% in European children

Paper title: A comparison of myopia control in European children and adolescents with defocus incorporated multiple segments (DIMS) spectacles, atropine, and combined DIMS/atropine

Authors: Paolo Nucci (1), Andrea Lembo (2), Irene Schiavetti (3), Rakhee Shah (4,5), David Francis Edgar (4,5), Bruce John William Evans (4,5)

1. Department of Biomedical, Surgical and Dental Sciences, University of Milan, Milan, Italy
2. Department of Biomedical, Surgical and Dental Sciences, University of Milan San Giuseppe Hospital, Milan, Italy,
3. Department of Health Sciences, Section of Biostatistics, University of Genoa, Genoa, Italy,
4. Research Department, Institute of Optometry, London, United Kingdom
5. Department of Optometry and Visual Sciences, School of Health and Psychological Sciences, University of London, London, United Kingdom

Date: Feb 2023

Reference:  Nucci P, Lembo A, Schiavetti I, Shah R, Edgar DF, Evans BJW. A comparison of myopia control in European children and adolescents with defocus incorporated multiple segments (DIMS) spectacles, atropine, and combined DIMS/atropine. PLoS One. 2023 Feb 16;18(2): e0281816 [Link to open access paper]

This study explored the efficacy of DIMS lenses, atropine and the combination of DIMS and atropine in slowing myopic progression in 146 European children. Read more about the DIMS spectacle lens here.

This was a non-randomised, prospective controlled observational study based in a European paediatric ophthalmology clinic.

Children had spherical equivalent refractive error (SER) between -0.50D and -4.00D, astigmatism of no more than 2.50DC and were aged between 6 and 18yrs. They were instructed to wear their spectacles for all waking hours.

Cycloplegic auto-refraction and axial length were measured at baseline, and again at 3-, 6- and 12-month intervals. Examiners were masked to the chosen intervention method.

• There were 30 children who wore DIMS spectacles, 53 who received the 0.01% atropine, 31 who wore the atropine+DIMS combination and 32 who wore single vision spectacles as the control group. This gave three treatment groups and one control group.
• The mean age was 10.3yrs in all children, but the DIMS only group was older and the atropine groups were younger than the control group. Baseline refractions were different between groups but baseline axial lengths were mostly similar. This means that the groups were not matched at baseline, but the authors report that these differences were corrected for in subsequent analyses.
• All treatment groups showed significantly reduced myopic progression compared to the control group. The measured refractive and axial length control effects were at least 50% for all treatments at 12 months.
• After 12 months, the atropine+DIMS group showed significantly reduced refractive progression (SER) compared to DIMS only and atropine only, although the differences were only around 0.1D.
• After 12 months, all treatment groups showed similar axial length progression, indicating no treatment was superior on this basis. Axial elongation was 0.17mm in the control group, compared to 0.066mm in DIMS, 0.049mm in DIMS+atropine and 0.09mm in atropine groups respectively (which were not significantly different).

Since the atropine+DIMS group was younger, these results point towards an increased effect when combining the treatments - while the refractive outcomes found a small additional benefit, the small 'boost' found in axial length control was not statistically significant.

There are two key findings from this study, in relation to the myopia control efficacy of DIMS, atropine 0.01% and their combination.

1. For the European children in this study, the DIMS spectacles and 0.01% atropine were both effective in reducing myopic progression and axial elongation. Combining DIMS and atropine 0.01% had a small addition benefit for refractive progression and a trend towards improved axial length control, although the latter did not reach statistical significance. This is the first study to report DIMS efficacy in European children, which appears to be comparable to findings of the randomized controlled trial undertaken in Asian children.
2. Atropine 0.01% was found to have an approximate 50% refractive and axial length control effect in European children. The authors point out that "reduced [iris] pigmentation in populations of European racial origin raises the possiblity that 0.01% may be more effective" than previous reports, such as the LAMP study, undertaken in Asian children.

1. Whether the outcomes would be different in a randomized controlled trial. In this study, the participants were attending a paediatric ophthalmology clinic and were able to choose their own treatment option. Although this does reflect normal clinical practice, a lack of randomisation in the study means there may be a risk of bias. Also, the clinic the children were attending was known for myopia control, which may have made them more compliant with the treatment plan.
2. If other studies would confirm the additive effective of atropine 0.01%+DIMS spectacles. Thus far, only the combination of orthokeratology and atropine 0.01% has shown additive efficacy for myopia control. This is the first data to show a limited combination effect with a myopia control spectacle and atropine 0.01%. Studies in other ethnicities would also contribute to understanding of tolerance and efficacy of combination treatment.
3. Long-term efficacy and any potential rebound effect from atropine cessation is yet to be investigated.

Title: A comparison of myopia control in European children and adolescents with defocus incorporated multiple segments (DIMS) spectacles, atropine, and combined DIMS/atropine

Authors: Paolo Nucci, Andrea Lembo, Irene Schiavetti, Rakhee Shah, David Francis Edgar, Bruce John William Evans

Purpose: To evaluate the efficacy of a myopia control spectacle lens (DIMS) at slowing the progression of myopia in a population of European children in comparison with 0.01% atropine and combined DIMS and atropine.

Methods: The study was a non-randomised experimenter-masked prospective controlled observational study of individuals aged 6-18 years with progressing myopia but no ocular pathology. Participants were allocated, according to patient/parent choice, to receive 0.01% atropine eyedrops, DIMS (Hoya® MiyoSmart®) spectacles, combined atropine+DIMS or single vision spectacle lenses (control group). The key outcome variables, cycloplegic autorefraction spherical equivalent refraction (SER) and axial length (AL), were measured at baseline and after three, six, and 12 months.

Results: Of the 146 participants (mean age 10.3y ±3.2), 53 received atropine, 30 DIMS spectacles, 31 atropine+DIMS, and 32 single vision control spectacles. Generalized linear mixed model analysis revealed for SER, whilst controlling for age and SER at baseline, at each stage all treatment groups had significantly reduced progression compared with the control group (p<0.016). For AL, whilst controlling for baseline age and AL, at 6 and 12 months all treatment groups had significantly less progression than the control group (p<0.005). For SER only, in pairwise comparisons at 12 months the atropine+DIMS group had significantly reduced progression compared with the DIMS only and Atropine only groups (p<0.001).

Conclusions: In a European population, DIMS and atropine are effective at reducing myopia progression and axial elongation in progressing myopia and are most successful at reducing myopia progression when used in combination.

 [Link to open access paper]