Soft peripheral contact lens for eye elongation control (SPACE): 1-year results of a double-blinded randomized controlled trial

Purpose

To examine the safety and efficacy of soft multifocal contact lenses on slowing the rate of myopia progression.

Methods

A prospective, randomized, double-masked clinical trial was conducted including 115 children (55 boys and 60 girls) aged 8 to 15 years. Children were assigned to wear one of two daily disposable soft contact lens designs; a multifocal design (Pegavision) or a dual-focus design (MiSight, Coopervision) in both eyes for at least 8 h per day for one year. All contact lenses were replaced on a daily basis. Measurements were obtained using a logMAR vision meter, including objective refraction, handheld retinoscopy, high (96 %) and low (12 %) contrast sensitivity, and distance and near visual acuity. Axial length was measured every 6 months.

Results

After one year, the spherical equivalent refractive error and axial length of the experimental group (Pegavision) increased by −0.50 ± 0.48 D and 0.24 ± 0.16 mm, respectively, in the right eye and −0.47 ± 0.37 D and 0.23 ± 0.16 mm, respectively, in the left eye. The spherical equivalent refractive error and axial length of the control group (MiSight) increased by −0.48 ± 0.47 D and 0.22 ± 0.13 mm, respectively, in the right eye and by −0.50 ± 0.44 D and 0.23 ± 0.14 mm, respectively, in the left eye, with no significant differences observed between the two lens types.

Conclusions

The one-year results from this clinical trial show that the multifocal soft contact lenses used in the experimental group have a similar myopia control efficacy with respect to spherical equivalent refraction and axial length elongation as a commercially available dual focus soft contact lens design.