EDOF soft contact lenses slow myopia over 2 years

Paper title:
 Two-Year Myopia Management Efficacy of Extended Depth of Focus Soft Contact Lenses (MYLO) in Caucasian Children

Authors:
 Díaz-Gómez S (1,4), Burgos-Martínez M (2), Sankaridurg P (3), Urkia-Solorzano A (4), Carballo-Álvarez J (1,5)

1. Faculty of Optics and Optometry, Complutense University of Madrid, Madrid, Spain
2. Mark'ennovy, Madrid, Spain
3. School of Optometry and Vision Science, University of New South Wales, Sydney, Australia
4. Miranza Centro Oftalmológico Integral (COI), Bilbao, Spain
5. Faculty of Optics and Optometry, Complutense University of Madrid, Madrid, Spain

Date:
 Published online December 5, 2023

Reference:
Díaz-Gómez S, Burgos-Martínez M, Sankaridurg P, Urkia-Solorzano A, Carballo-Álvarez J. Two-Year Myopia Management Efficacy of Extended Depth of Focus Soft Contact Lenses (MYLO) in Caucasian Children. Am J Ophthalmol. 2024 Apr; 260:122–131.

[Link to open access paper]

A previous study has demonstrated efficacy of MYLO extended depth of focus (EDOF) contact lenses in Asian populations.¹   However, data in Caucasian children are limited. This study aimed to evaluate the two-year effectiveness of MYLO extended depth of focus (EDOF) soft contact lenses in reducing axial elongation and myopia progression compared to single-vision spectacles in a European cohort.

This was a prospective, non-randomized clinical trial involving 90 Spanish children aged 6–13 years with myopia ranging from –0.75 to –10.00 D. Forty-five participants wore MYLO EDOF contact lenses, and 45 wore single-vision spectacles. Cycloplegic spherical equivalent and axial length were measured at baseline and every 6 months over two years. Subjective assessments of visual performance were conducted after one month of contact lens wear. Key findings were as follows.

• MYLO EDOF contact lenses reduced absolute axial elongation by 0.29mm, compared to single vision spectacles over 24 months.
• 100% of MYLO wearers had axial elongation ≤0.50 mm, compared to 0% in the SV spectacle group.
• The mean myopia progression was –0.62 D in the MYLO group and –1.13 D in the spectacle group, a difference of 0.50 D.
• 53% of MYLO wearers had ≤–0.50 D progression in spherical equivalent, compared to only 1% of the spectacle group.
• Visual acuity with MYLO lenses was slightly lower than with spectacles (by <1 line), with no difference in contrast sensitivity.

The MYLO EDOF lens design incorporates a combination of higher order aberrations to provide a constantly changing power profile (non-monotonic) across the optic zone and extended depth of focus equivalent to 1.50D. This was the first clinical trial to investigate the 24-month efficacy of MYLO EDOF contact lenses for European children. 

The study had selected children who had already shown 0.50D myopia progression in the previous year, and MYLO wearers in this study experienced no more than 0.50D progression or more than 0.50mm axial growth over two years. Young children may present in clinical practice with prior progression before commencing myopia management, making these results clinically useful for eyecare practitioners. 

Although visual acuity was slightly reduced (by less than one line), contrast sensitivity was preserved, and the subjective ratings for comfort, visual clarity, and satisfaction were high.

This was a non-randomised clinical trial in which children who were previous attendees at the clinic had self-selected into either the contact lens or spectacle group. This introduces potential selection bias, although the authors note that high compliance and lack of drop-outs limit this impact. 

Although there were no differences for SE at baseline between the MYLO and spectacle groups, the spectacle group had longer baseline axial lengths. Although changes in AL over the study period did not appear to correlate with baseline AL, if the spectacle wearers were pre-disposed to faster progression, this could contribute to a greater treatment-control difference.

Randomised, multi-centre studies would confirm the efficacy of MYLO lenses over longer study periods and across a wide range of baseline progression rates. 

Purpose: To evaluate the progression of myopia as assessed by change in axial length (AL) and spherical equivalent (SE) from baseline in Caucasian children wearing extended depth of focus soft contact lenses (CLs) compared to distance single-vision spectacles.

Design: Prospective non-randomized comparative clinical trial.

Methods: A total of 90 children (6-13 years of age) with SE ranging from -0.75 to -10.00 diopters (D) were recruited. Of these children, 45 were fitted with CLs (MYLO, mark´ennovy), whereas 45 children wore spectacles. Cycloplegic refraction was measured with an auto-refractometer (Topcon-TRK-2P) and AL with an IOLMaster-700 (Zeiss) at 6-month intervals. Subjective responses after 1 month of CL wear related to vision and comfort were determined using a questionnaire with a scale from 1 (very poor) to 10 (excellent). High-contrast visual acuity (HCVA) and contrast sensitivity (CS) were evaluated at baseline, 12, and 24 months.

Results: After 2 years, mean change in SE/AL in the CL group was -0.62 ± 0.30 D/0.37 ± 0.04 mm and -1.13 ± 0.20 D/0.66 ± 0.03 mm in the spectacles group (P < .001). Cumulative absolute reduction in axial elongation (CARE) was 0.29 ± 0.06 mm. Difference in SE change was -0.50 ± 0.34 D. Although 100% of CL group had an AL increase ≤0.50 mm, all participants increased ≥0.50 mm in the spectacles group. In all, 53% of the CL group and 1% in the spectacles group showed a progression in SE ≤ -0.50D. All questionnaire items showed a mean value ≥9. There was a reduction logMAR HCVA in the CL compared to the spectacles group but it was less than 1 line (P < .001).

Conclusions: Use of MYLO CLs reduced axial elongation and myopia progression compared to use of distance single-vision spectacles.

[Link to open access paper]