How does MiSight perform for European children?

Paper title: MiSight Assessment Study Spain (MASS).  A 2-year randomised clinical trial

Authors: Ruiz-Pomeda, Alicia (1); Perez-Sanchez, Belen (2); Valls, Isabel (3); Prieto-Garrido, Francisco Luis (4); Gutierrez-Ortega, Ramon (3); Villa-Collar, Cesar (5)

1. Department of Pharmacy, Biotechnology, optics and Optometry, European University of Madrid, C/Tajo s/n, Villaviciosa de Odon, 28670 Madrid, Spain
2. Department of Statistics, Mathematics and Informatics, Area of Languages and Computer Systems, Miguel Hernandez University of Elche, Elche, Alicante, Spain
3. Clinica oftalmologica Novovision, Madrid, Spain
4. Department Optics I: Optometry and Vision, Universidad Complutense de Madrid, Spain
5. Doctoral and Research School, European University of Madrid, Madrid, Spain

Date: Feb 2018

Reference: Ruiz-Pomeda A, Pérez-Sánchez B, Valls I, Prieto-Garrido FL, Gutiérrez-Ortega R, Villa-Collar C. MiSight Assessment Study Spain (MASS). A 2-year randomized clinical trial. Graefes Arch Clin Exp Ophthalmol. 2018 May;256(5):1011-1021

[Link to abstract]

MiSight daily soft contact lens (Coopervision) is intended for myopia management and incorporate a 11.66mm optic zone with 4 alternating distance and near zones around a 3.36mm central distance area.  A near power of +2.00D provides the treatment zone and a defocused image, which superimposes the distance image to adjust the position of the peripheral defocus. 

The authors of this 2-year randomised clinical study fit 41 European children aged between 8 and 12yrs old with MiSight and compared their myopia progression to 33 children wearing single vision spectacle lenses.  

MiSight contact lenes were found to reduce myopia progression by -0.29D (39.2%) and axial length growth by 0.16mm (36.4%). Further research is needed into the effectiveness of treatment times longer than 2 years and the myopia progression likely when treatment is halted. 

MiSight lenses are able to provide a statistically significant 39% reduction in myopia progression over a 2yr period.

• Eye care practitioners can be confident of the treatment effect of MiSight compared to prescribing single vision spectacle lenses alone that have no treatment effect .

Many studies regarding childhood myopia have featured children of Asian descent due to a higher prevalence, and faster progression, of myopia. 

• Where the participants in this study were primarily white Caucasian, the results are more directly applicable to European children.

The study participants were aged between 8 and 12 yrs. However, the children in the single vision spectacle control group were slightly younger at baseline (10.12 ± 1.38 years compared to 11.01 ± 1.23 years for the MiSight group):

• Younger children have been found to demonstrate faster myopic progression than older children¹
• The authors adjusted for age as a covariate and found it was not associated with the final myopic progression differences.
• Further research could confirm if the treatment effect found here for 8-12yr old children would be similar for children older and younger than this.

MiSight contact lenses (along with other available myopia management options) are based on altering retinal peripheral defocus in order to achieve slowing of progression:

• There are other factors that have been shown to also have some influence on myopia development and progression in children, including time spent indoors or on near studies², parental myopia, or accommodative and binocular vision issues.
• The role of MiSight alongside other controlled factors can be explored further.
• Future studies can confirm the optimum treatment timescale for maximising progression reduction, the appropriate stage for discontinuing wear and if progression is likely to resume when treatment is halted.

Neither peripheral refraction or accommodation were measured or allowed for during this study, mostly due to inherent difficulties measuring peripheral refraction with an open-field auto-keratometer:

• Further studies could investigate the role of accommodation and consider the extent of the myopic defocus on the peripheral retina.

[Link to abstract]Title: MiSight Assessment Study Spain (MASS).  A 2-year randomised clinical trial

Authors: Ruiz-Pomeda, Alicia; Perez-Sanchez, Belen; Valls, Isabel; Prieto-Garrido, Francisco Luis; Gutierrez-Ortega, Ramon; Villa-Collar, Cesar

Purpose: To compare myopia progression in children randomized to MiSight contact lenses (CLs) versus children corrected with single-vision spectacles (SV) over a 2-year period.

Methods: Subjects aged 8 to 12 with myopia (-0.75 to -4.00 D sphere) and astigmatism (< -1.00 D cylinder) were assigned to the lens study group (MiSight) or the control group (single vision). Measurements of visual acuity and subjective refraction were taken at 6-month intervals, and axial length, anterior chamber, corneal power, and cycloplegic autorefraction were measured at the baseline, 12-month, and 24-month visits.

Results: Eighty-nine subjects were recruited. Forty-fix children were assigned to the MiSight group, and 33 to the single-vision spectacle group. In total, 74 children completed the clinical trial, with the following parameters at the beginning of the study: n = 41 in the MiSight group (age: 11.01 ± 1.23 years, spherical equivalent: -2.16 ± 0.94 D, gender: male: 21, female: 20) and n = 33 in the single-vision group (age: 10.12 ± 1.38 years, spherical equivalent: -1.75 ± 0.94 D, gender: male: 12, female: 21). After 2 years of follow-up, myopia progressed slowly in the MiSight group compared to the control group (0.45 D vs 0.74 D, p < 0.001) and there was less axial elongation in the MiSight group compared to the single-vision group (0.28 mm vs 0.44 mm, p < 0.001). Therefore, use of MiSight CLs produced lower myopia progression (39.32%) and lower axial growth of the eye (36.04%) at 2 years compared to spectacle use.

Conclusions: MiSight contact lens wear reduces axial elongation and myopia progression in comparison to distance single-vision spectacles in children.