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

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, markennovy), 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. (Am J Ophthalmol 2024;260: 122-131. (c) 2023 The Authors. Published by Elsevier Inc. This is an open access article