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.

Keywords: Clinical Trial; Contact lens; Vision.

Figure 1

Flow chart of the study.

Figure 2

The mean change in spherical equivalent refraction (A: left panel) and axial length (B: right panel) between the baseline and 12-month period. Error bars represent the SE of the mean. p<0.05, indicated by asterisks*.

Figure 3

Percentage responses from the participants related to comfort, visual disturbances and compliance for those who wore the contact lenses in the treatment group.