A 3-year Randomized Clinical Trial of MiSight Lenses for Myopia Control

Abstract

SIGNIFICANCE: Results of this randomized, double-masked clinical trial demonstrate the effectiveness of the MiSight soft contact lens in slowing myopia progression over multiple years. PURPOSE: The purpose of this study was to quantify the effectiveness of MiSight daily disposable soft contact lens in slowing the progression of juvenile-onset myopia. METHODS: Myopic children (spherical equivalent refraction, −0.75 to −4.00 D; astigmatism, <1.00 D) aged 8 to 12 years with no prior contact lens experience were enrolled in a 3-year, double-masked, randomized clinical trial at four investigational sites in four countries. Subjects in each group were matched for age, sex, and ethnicity and were randomized to either a MiSight 1-day contact lens (test) or Proclear 1-day (control; omafilcon A) and worn on a daily disposable basis. Primary outcome measures were the change in cycloplegic spherical equivalent refraction and axial length. RESULTS: Of the subjects enrolled, 75.5% (109/144) completed the clinical trial (53 test, 56 control). Unadjusted change in spherical equivalent refraction was −0.73 D (59%) less in the test group than in the control group (−0.51 ± 0.64 vs.-1.24 ± 0.61 D, P < .001). Mean change in axial length was 0.32 mm (52%) less in the test group than in the control group (0.30 ± 0.27 vs. 0.62 ± 0.30 mm, P < .001). Changes in spherical equivalent refraction and axial length were highly correlated (r = −0.90, P < .001). Over the course of the study, there were no cases of serious ocular adverse events reported. Four asymptomatic corneal infiltrative (one test, three control) events were observed at scheduled study visits. CONCLUSIONS: Results of this clinical trial demonstrate the effectiveness of the MiSight daily disposable soft contact lens in slowing change in spherical equivalent refraction and axial length.

Correction of presbyopia: old problems with old (and new) solutions

“…Likewise, orthokeratology also produces an eye with myopia in the peripheral optics or equivalently an eye with positive corneal plane spherical aberration . Consistent with the hypothesis of removing peripheral hyperopia from the retinal image, these multifocal concentric ring and annular contact lens designs and the multifocal orthokeratology corneas have generally shown promise at slowing myopia development …”

“…27,[160][161][162] Consistent with the hypothesis of removing peripheral hyperopia from the retinal image, these multifocal concentric ring 163 and annular [164][165][166] contact lens designs and the multifocal orthokeratology corneas have generally shown promise at slowing myopia development. 163,[167][168][169][170][171][172][173] Lessons from evolution Evolution developed some of the multifocal strategies now used to correct presbyopia, and the need for improved surrogates for accommodation grows every day as the presbyopic population grows toward an estimated 1.8 billion by 2050. 174,175 Additionally, the value of multifocal optics has expanded due to its ability to slow myopia progression.…”

“…Evolution developed some of the multifocal strategies now used to correct presbyopia, and the need for improved surrogates for accommodation grows every day as the presbyopic population grows toward an estimated 1.8 billion by 2050 . Additionally, the value of multifocal optics has expanded due to its ability to slow myopia progression . As work continues to optimise these designs, there may be as yet untried evolutionary strategies that can be adapted.…”

“…174,175 Additionally, the value of multifocal optics has expanded due to its ability to slow myopia progression. 163,[167][168][169][170][171][172][173] As work continues to optimise these designs, there may be as yet untried evolutionary strategies that can be adapted. The true long-term solution, and where much of our future research likely may need to occur may be in preventing the onset of presbyopia in the first place.…”

Myopia management in the Netherlands

“…Between 2011 and 2019, 9 randomised trials with soft dual focus contact lenses were published . Four studies used lenses with a concentric design; the other studies used lenses with a progressive design.…”