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Visual Performance of School-age Children Wearing Dual-Focus Soft Contact Lenses: A Randomized Controlled Trial
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摘要:目的
研究配戴同心双焦设计软性接触镜（dual-focus soft contact lenses, DFSCL）对学龄儿童视觉表现的影响。
方法本随机对照临床试验于2022年10月于我院招募了64名等效球镜度在－0.75 D至－4.00 D之间的8～12岁儿童。采用信封法随机分配为两组，每组32名受试者，分别配戴单光框架眼镜（single vision spectacles, SVS）和MiSight DFSCL。每3个月进行一次随访检查，比较对照组和干预组的矫正视力、对比敏感度功能（contrast sensitivity function, CSF）和美国国家眼科研究所——屈光不正生活质量问卷42题（National Eye Institute Refractive Error Quality of Life Instrument-42, NEI-RQL-42）评分。
结果截止2023年12月，共有58名受试者完成了随访（SVS组30人，DFSCL组28人）。配戴MiSight DFSCL后的矫正视力和配戴SVS后的矫正视力差异没有统计学意义。在3、6、12、18 cpd的空间频率下，DFSCL组的CSF与SVS组相当（P>0.05）。在随访的第6个月进行的NEI-RQL-42问卷调查中，眼部不适症状方面，SVS组得分为89±14，DFSCL组为79±16（P=0.008），DFSCL组较SVS组差12.66%；外观方面，SVS组得分为70±32，DFSCL组为92±22（P=0.002），DFSCL组较SVS组好31.43%。
结论除能提供同样正常的视觉敏锐度和对比敏感度，配戴MiSight DFSCL还能获得更好的外观满意度。
Abstract:ObjectiveTo investigate the effect of wearing dual-focus soft contact lenses (DFSCL) on the visual performance of school-age children.
MethodsIn this randomized controlled clinical trial, 64 children aged 8 to 12 years with spherical equivalent refraction between −0.75 D and −4.00 D were recruited in our hospital in October 2022. Using the envelope method, the subjects were evenly and randomly assigned to the control group wearing single vision spectacles (SVS) or the intervention group wearing MiSight dual-focus soft contact lenses (DFSCL) from CooperVision. Follow-up examinations were conducted once every 3 months. The corrected visual acuity, contrast sensitivity function (CSF), and the scores for National Eye Institute Refractive Error Quality of Life Instrument-42 (NEI-RQL-42) were compared between the control and intervention groups.
ResultsBy December 2023, a total of 58 subjects completed follow-up (30 in the SVS group and 28 in the DFSCL group). No significant difference in corrected visual acuity was observed between subjects wearing DFSCL and those wearing SVS. The CSF of the DFSCL group was comparable to that of the SVS group across the spatial frequencies of 3, 6, 12, and 18 cpd (P>0.05). According to the results of the NEI-RQL-42 survey at the 6-month follow-up, the score for ocular discomfort symptoms was 89±14 in the SVS group and 79±16 in the DFSCL group (P=0.008), reflecting that the DFSCL group had a 12.66% higher level of discomfort. For appearance, the score was 70±32 in the SVS group and 92±22 in the DFSCL group (P=0.002), showing a 31.43% improvement in the DFSCL group.
ConclusionIn addition to providing the normal visual acuity and CSF, wearing MiSight DFSCL also leads to better satisfaction with the appearance.
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Keywords:
- Soft contact lenses /
- Peripheral defocus /
- Visual performance /
- School-age children
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图 2 随访期间，SVS组（A）和DFSCL组（B）在4种空间频率下的对比敏感度
Figure 2. Contrast sensitivity at four spatial frequencies in SVS (A) and DFSCL (B) groups during the follow-up period
表 1 基线特征
Table 1 Baseline characteristics
Item SVS (n=30) DFSCL (n=28) P Age/yr. 9.92±1.22 9.91±1.11 0.962 (Female/male)/case 20/10 17/11 0.644 AL/mm 24.57±0.66 24.21±0.73 0.051 Cycloplegic SER/D −1.95±0.68 −1.88±0.79 0.733 Values are presented as $\bar x \pm s$. AL: axial length; SER: spherical equivalent refraction. 
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表 2 最佳矫正视力（logMAR）
Table 2 Best corrected visual acuity (logMAR)
Time SVS group (n=30) DFSCL group (n=28) P Baseline −0.057±0.049 −0.039±0.045 0.098 3 months −0.047±0.046 −0.038±0.048 0.268 6 months −0.034±0.046 −0.053±0.043 0.108 9 months −0.025±0.040 −0.045±0.046 0.092 12 months −0.031±0.049 −0.049±0.047 0.091
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表 3 对比敏感度功能
Table 3 Contrast sensitivity function
Time Spatial frequencies 3 cpd 6 cpd 12 cpd 18 cpd Baseline SVS group 1.69±0.23 1.84±0.22 1.54±0.18 1.12±0.20 DFSCL group 1.76±0.23 1.77±0.19 1.46±0.28 1.06±0.20 P (between groups) 0.233 0.151 0.307 0.193 3 months SVS group 1.67±0.20 1.82±0.17 1.52±0.22 1.07±0.24 DFSCL group 1.67±0.18 1.77±0.13 1.45±0.24 1.05±0.24 P (between groups) 0.974 0.261 0.250 0.501 6 months SVS group 1.70±0.24 1.86±0.22 1.51±0.24 1.09±0.25 DFSCL group 1.72±0.23 1.78±0.17 1.44±0.20 1.00±0.29 P (between groups) 0.638 0.152 0.178 0.190 12 months SVS group 1.72±0.19 1.88±0.26 1.58±0.25 1.12±0.27 DFSCL group 1.70±0.18 1.81±0.17 1.46±0.25 1.05±0.21 P (between groups) 0.842 0.332 0.082 0.383 The data in the table are the log value of the contrast sensitivity. n=30 in the SVS group and n=28 in the DFSCL group.
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表 4 NEI-RQL-42中的13个分量表和总分
Table 4 Results for the 13 subscales of NEI-RQL-42 and the total score
Subscales Follow-up Friedman test Baseline 3 months 6 months χ2 P Clarity of vision SVS group 86±12 93±10 91±11 4.956 0.084 DFSCL group 80±19 89±12 92±9 9.928 0.007* P (between groups) 0.341 0.253 0.968 Expectations SVS group 25±25 18±23 25±29 2.083 0.353 DFSCL group 15±25 17±26 23±28 0.926 0.629 P (between groups) 0.081 0.630 0.780 Near vision SVS group 85±11 90±10 91±11 10.048 0.007* DFSCL group 86±12 88±11 91±12 3.651 0.161 P (between groups) 0.642 0.427 0.897 Far vision SVS group 90±13 92±9 95±7 5.865 0.053 DFSCL group 90±12 94±11 92±12 3.647 0.161 P (between groups) 0.968 0.194 0.518 Diurnal fluctuations SVS group 87±15 92±13 92±14 2.548 0.280 DFSCL group 91±15 90±14 95±10 6.040 0.049* P (between groups) 0.317 0.430 0.614 Activity limitations SVS group 96±8 93±11 93±14 1.458 0.482 DFSCL group 91±13 92±15 93±17 1.792 0.408 P (between groups) 0.208 0.665 0.834 Glare SVS group 79±17 83±19 88±19 9.106 0.011* DFSCL group 61±25 81±22 79±24 14.175 0.000* P (between groups) 0.006* 0.897 0.072 Symptoms SVS group 87±13 87±13 89±14 2.094 0.351 DFSCL group 81±17 79±16 79±16 0.765 0.682 P (between groups) 0.202 0.035* 0.008* Dependence on correction SVS group 84±25 79±19 78±25 5.255 0.072 DFSCL group 80±29 78±27 81±24 1.300 0.522 P (between groups) 0.524 0.474 0.524 Worry SVS group 49±24 60±30 56±31 4.144 0.126 DFSCL group 56±27 57±25 54±29 0.245 0.885 P (between groups) 0.273 0.615 0.771 Suboptimal correction SVS group 94±15 96±12 93±16 3.440 0.179 DFSCL group 93±13 97±9 96±9 1.600 0.449 P (between groups) 0.493 0.700 0.728 Appearance SVS group 63±34 75±30 70±32 8.495 0.014* DFSCL group 69±34 98±6 92±22 17.464 0.000* P (between groups) 0.282 0.000* 0.002* Satisfaction with correction SVS group 80±24 89±15 92±16 7.895 0.019* DFSCL group 84±26 94±13 94±12 7.257 0.027* P (between groups) 0.389 0.089 0.819 Total score SVS group 81±6 83±6 84±7 8.622 0.013* DFSCL group 78±9 83±8 84±8 13.532 0.001* P (between groups) 0.256 0.938 0.944 SVS group (n=30), DFSCL group (n=28). * Statistical significance P by Mann-Whitney U test and Friedman nonparametric test. For intra-group analysis, further post-hoc analysis requires a significant difference< 0.0167 after Bonferroni correction.
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