CEORLab, Centre of Physics, Clinical and Experimental Optometry Research Lab, University of Minho, Campus de Gualtar, 4710-057, Braga, Portugal.
Servicio de Oftalmología. Hospital Universitario de Mostoles, Mostoles, Madrid, Spain.
BMC Ophthalmol. 2021 Mar 1;21(1):112. doi: 10.1186/s12886-021-01865-y.
To compare ocular and corneal inherent aberrations in the naked eyes of randomly selected children fitted with MiSight contact lenses (CL) for myopia control, versus children corrected with single-vision spectacles (control), over a 24-months period.
Children aged 8 to 12 years, with myopia (-0.75 to -4.00 D sphere) and astigmatism (< -1.00 D cylinder) were randomly assigned to the lens study group (MiSight) or the control group (single-vision spectacles). The root mean square aberration (RMS) was determined as corneal (RMS_C), corneal high order RMS (HO_RMS_C), corneal low order RMS (LO_RMS_C), ocular (total) RMS (RMS_T), ocular high order RMS (HO_RMS_T), ocular low order RMS (LO_RMS_T), corneal spherical aberration (SA_C) and ocular SA (SA_T) were calculated by aberrometry measures at the baseline, on 12-months and 24-months visits. A 5 mm diameter was defined for the analysis in all visits for all subjects. Only the dominant eye was analyzed.
Seventy-four subjects completed the clinical trial: 41 subjects from the MiSight group (age: 11.01 ± 1.23 years) and 33 from the single-vision group (age: 10.12 ± 1.38 years). RMS_T significantly changed (0.57 ± 0.20 µm, p = 0.029) after 24-months in the control group. In the MiSight group no significant changes were registered (p > 0.05). The SA_C and SA_T did not reveal significant changes between visits or between groups (p > 0.05).
Along 2 years, MiSight CL did not induce significant changes in RMS of anterior cornea or total ocular RMS. Contrary, in control group the RMS_T significantly changed as response of greater eye growth and myopia progression. The results obtained in present study allow to predict corneal or total aberration changes, in children, in response of wearing of MiSight lens along the time.
ClinicalTrials.gov Identifier: NCT01917110.
比较随机选择的佩戴离焦软镜（MiSight）控制近视的儿童和单焦眼镜（对照组）矫正的儿童 24 个月期间的裸眼眼内和角膜固有像差。
8 至 12 岁的近视儿童（球镜-0.75 至-4.00D，柱镜<-1.00D）随机分为镜片研究组（MiSight）或对照组（单焦眼镜）。通过离焦测量确定均方根像差（RMS）值，包括角膜 RMS（RMS_C）、角膜高阶 RMS（HO_RMS_C）、角膜低阶 RMS（LO_RMS_C）、眼内总 RMS（RMS_T）、眼内高阶 RMS（HO_RMS_T）、眼内低阶 RMS（LO_RMS_T）、角膜球差（SA_C）和眼内 SA（SA_T）。在基线、12 个月和 24 个月随访时进行测量。所有受试者的所有检查均采用 5mm 直径分析。仅对优势眼进行分析。
74 名受试者完成了临床试验：MiSight 组 41 名（年龄：11.01±1.23 岁），单焦组 33 名（年龄：10.12±1.38 岁）。对照组在 24 个月时 RMS_T 显著改变（0.57±0.20μm，p=0.029）。MiSight 组无显著变化（p>0.05）。角膜和眼内 SA 在随访或组间均无显著变化（p>0.05）。
2 年内，MiSight CL 不会导致角膜前 RMS 或眼内总 RMS 显著改变。相反，对照组 RMS_T 显著改变，提示眼轴增长和近视进展。本研究结果可预测佩戴 MiSight 镜片时儿童角膜或总像差的变化。
ClinicalTrials.gov 标识符：NCT01917110。
