Department of Ophthalmology (J.F., Y.L., M.Z., Q.W., X.C., W.X., C.D.), The First Affiliated Hospital, Zhejiang University School of Medicine, Hangzhou, Zhejiang Province, P. R. China; and Department of Ophthalmology (Z.H., C.D.), The Fourth Affiliated Hospital, Zhejiang University School of Medicine, Yiwu, Zhejiang Province, P. R. China.
Eye Contact Lens. 2022 Aug 1;48(8):328-334. doi: 10.1097/ICL.0000000000000911. Epub 2022 Jun 3.
This randomized, single-blind, clinical trial compared the effectiveness of multifocal soft contact lenses (MFSCLs), orthokeratology contact lenses (Ortho-kCLs), and single vision spectacles (SVSs) for myopia control.
Sixty-six eligible Chinese subjects, aged 7 to 15 years old with cycloplegic refraction measurements between -1.00 and -8.00 diopters (D), astigmatism not more than 1.00 D, and no history of myopia control treatment, were randomly assigned to wear MFSCLs, Ortho-kCLs, or SVSs for 1 year. For all three groups, baseline measurements of cycloplegic refraction, axial length (AL), and corneal endothelial cell density (CECD) were made. At the 6- and 12-month follow-up visits, changes in cycloplegic refraction, AL, and CECD were measured in the MFSCL and SVS groups. For the Ortho-kCL group, only changes in the AL were measured at 6 and 12 months, and CECD was measured at the 12-month follow-up visit.
After 1 year of lens wear, myopia progression of the SVS group, -0.938±0.117 D, was greater than that of the MFSCLs group, -0.591±0.106 D (P=0.032). Thus, MFSCLs reduced the rate of myopia progression by 37.0% compared with the SVSs. The AL elongations after 1 year were 0.30±0.03 mm for MFSCLs (P=0.027 vs SVSs), 0.31±0.04 mm for Ortho-kCLs (P=0.049 vs SVSs), and 0.41±0.04 mm for SVSs. Compared with the SVS group, the reduction in AL elongation was 26.8% and 24.4% in the MFSCL and Ortho-kCL groups, respectively. There were no significant differences in CECD among the three groups (P>0.05).
Compared with SVSs, wearing MFSCLs and Ortho-kCLs significantly delayed myopia progression. MFSCLs and Ortho-kCLs are safe and promising methods of myopia control (chictr.org number, ChiCTR2100048452).
本随机、单盲临床试验比较了多焦点软镜(MFSCLs)、角膜塑形镜(Ortho-kCLs)和单光眼镜(SVSs)在近视控制中的疗效。
66 名符合条件的中国受试者,年龄 7 至 15 岁,睫状肌麻痹验光屈光度在-1.00 至-8.00 屈光度(D)之间,散光不超过 1.00 D,且无近视控制治疗史,随机分配至 MFSCLs、Ortho-kCLs 或 SVSs 组,佩戴 1 年。对于所有三组,均进行睫状肌麻痹验光、眼轴(AL)和角膜内皮细胞密度(CECD)的基线测量。在 6 个月和 12 个月的随访中,测量 MFSCL 和 SVS 组中睫状肌麻痹验光、AL 和 CECD 的变化。对于 Ortho-kCL 组,仅在 6 个月和 12 个月时测量 AL 的变化,在 12 个月的随访时测量 CECD。
佩戴 1 年后,SVS 组近视进展-0.938±0.117 D,大于 MFSCLs 组-0.591±0.106 D(P=0.032)。因此,MFSCLs 使 SVSs 的近视进展率降低了 37.0%。佩戴 1 年后,MFSCLs 组的 AL 伸长量为 0.30±0.03 mm(P=0.027 与 SVSs 组相比),Ortho-kCLs 组为 0.31±0.04 mm(P=0.049 与 SVSs 组相比),SVSs 组为 0.41±0.04 mm。与 SVS 组相比,MFSCL 和 Ortho-kCL 组的 AL 伸长减少分别为 26.8%和 24.4%。三组间 CECD 无显著差异(P>0.05)。
与 SVSs 相比,佩戴 MFSCLs 和 Ortho-kCLs 可显著延缓近视进展。MFSCLs 和 Ortho-kCLs 是安全且有前途的近视控制方法(chictr.org 编号:ChiCTR2100048452)。