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Randomized Controlled Trial
. 2022 Aug 16;22(1):345.
doi: 10.1186/s12886-022-02562-0.

Spectacle lenses with slightly aspherical lenslets for myopia control: clinical trial design and baseline data

Junhong Chen #  1   2 , Ran Zhuo #  1   2 , Jiayan Chen  2 , Adeline Yang  3   4 , Ee Woon Lim  3   4 , Jinhua Bao  1   3 , Björn Drobe  3   4 , Daniel P Spiegel  3   4 , Hao Chen  5   6 , Lijie Hou  7
Affiliations
Randomized Controlled Trial

Spectacle lenses with slightly aspherical lenslets for myopia control: clinical trial design and baseline data

Junhong Chen et al. BMC Ophthalmol. .

Abstract

Objectives: Myopia is a major public health problem and it is essential to find safe and effective means to control its progression. The study design and baseline data are presented for a one-year prospective, double-masked, crossover, randomized clinical trial evaluating the efficacy of single vision spectacle lenses with concentric rings of slightly aspherical contiguous lenslets technology (SAL) on myopia control.

Methods: One hundred 8- to 13-year old Chinese children with a refractive error of -0.75 D to -4.75 D were assigned to two groups. In Group 1, SAL and single vision lenses were each worn for 6 months, and Group 2 wore the lenses in the reversed order. Primary outcomes are axial length and spherical equivalent of cycloplegic refractive error. Secondary outcomes included corneal thickness, anterior chamber depth, lens thickness, visual acuity, and lens adaptation.

Results: No significant differences in baseline parameters (cycloplegic spherical equivalent, axial length, age) were found between groups (0.49 < p < 0.94). All children adapted well to the test lenses and there was no significant difference in visual acuity between the SAL and single vision lenses (p = 0.27).

Conclusions: The children in the two well balanced groups had comparable visual acuity and adapted well to the test lenses. These results imply that visual acuity can be well improved by SAL lenses. Clear visual acuity provides the assurance for good compliance in this longitudinal study.

Keywords: Axial length; Myopia; Prospective studies; Refractive errors; Spectacle lenses.

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Conflict of interest statement

Jinhua Bao is the Associate Director of Wenzhou Medical University–Essilor International Research Centre. Adeline Yang, Daniel P. Spiegel and Björn Drobe are employees of Essilor International, the company that supplied the study device and holds the following patent applications related to this work: WO2019166653 WO2019166654 WO2019166655.

No conflicts of interest exist for the rest of the authors.

Figures

Fig. 1
Fig. 1
Flow chart of the study; M – month(s), W – week(s)
Fig. 2
Fig. 2
Distributions and relationships between the primary outcome measures at baseline. Left panel – axial length (AL), middle panel – cycloplegic spherical equivalent (SER), right panel – correlations between AL and SER. Lighter shade shows Group 1 (SAL); darker shade Group 2 (single vision lens; SVL). Triangles filled with the corresponding shade indicate the groups’ means
See this image and copyright information in PMC

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