Randomised clinical trial of extended depth of focus lenses for controlling myopia progression: Outcomes from SEED LVPEI Indian Myopia Study

Abstract

Purpose To determine the efficacy of extended depth of focus (EDOF) contact lenses for controlling myopia progression in children through a 1-year randomised clinical trial. Methods A total of 104 children aged 7-15 years, with spherical equivalent refraction ≤−0.50 D, were randomly assigned to wear SEED 1 dayPure EDOF Mid contact lenses (n=48) or single vision spectacle lenses (n=56). Cycloplegic refraction with Shin-Nippon open field autorefractor and axial length with Lenstar LS 900 was determined at the baseline and 12-month visits. The compliance, visual discomfort and dryness questionnaires were administered during the final visit. Results Sixty-nine children (control: n=38; treatment: 31) completed the 12-month follow-up visit, with no difference in baseline characteristics between the groups. Mean (SEM) myopia progression in the 12th month was −0.48±0.07D in the control group and −0.20±0.08D in the treatment group. Mean axial elongation was 0.22±0.03 mm and 0.11±0.03 mm in the control and treatment groups, respectively. SEED 1 dayPure EDOF Mid contact lenses slowed myopia progression by 59% (−0.28D; p=0.01) based on spherical equivalent refraction and controlled axial length by 49% (0.11 mm; p=0.007) in comparison to single vision spectacle lenses. None of the participants reported any adverse effects. While most of the participants (82%) were comfortable with the contact lenses, 11% reported occasional dryness and 14% experienced mild fluctuations in visual acuity after immediate lens wear. Conclusion Daily wear of SEED 1 dayPure EDOF Mid contact lenses in Indian children showed a significant effect in controlling myopia progression and axial elongation.