Huang Yingying, Li Xue, Wang Chu, Zhou Fengchao, Yang Adeline, Chen Hao, Bao Jinhua
Eye Hospital and School of Ophthalmology and Optometry, Wenzhou Medical University, 270 West Xueyuan Road, Wenzhou, 325027, Zhejiang, China.
National Clinical Research Center for Ocular Diseases, Wenzhou, Zhejiang, China.
Eye Vis (Lond). 2022 Sep 1;9(1):33. doi: 10.1186/s40662-022-00304-3.
To investigate the short- and long-term effects of myopia control spectacle lenses with highly aspherical lenslets (HAL) and slightly aspherical lenslets (SAL) on visual function and visual quality using data obtained from a randomized controlled clinical trial.
This was a prospective, randomized, controlled, and double-blinded study; 170 myopic children aged 8-13 years were randomly assigned to the HAL, SAL, or single-vision spectacle lenses (SVL) groups. Distance and near visual acuity (VA) at high (100%) and low (10%) contrast in photopic and scotopic conditions, near phoria, stereoacuity, and accommodative lag, microfluctuations (AMFs), amplitude (AA) were measured after wearing lenses for 10 min, 6 months, and 12 months.
In total, 161 subjects completed all follow-up in 12 months and were included in the analysis. After 10 min of wearing, the HAL and SAL groups had lower scotopic and low-contrast VA than the SVL group (decreased 0.03-0.08 logMAR and 0.01-0.04 logMAR in different VAs in the HAL and SAL groups, respectively, all P < 0.05). The reduction in VA was recovered at 12 months as the HAL and SAL groups exhibited significant VA improvements, and the VA was not different among the three groups (all P > 0.05). The HAL and SAL groups had significantly larger AMFs than the SVL group (HAL vs. SAL vs. SVL: 0.21 ± 0.08 D vs. 0.16 ± 0.05 D vs. 0.15 ± 0.06 D at baseline, 0.19 ± 0.07 D vs. 0.17 ± 0.05 D vs. 0.13 ± 0.07 D at 12 months, all P < 0.05). There were no significant differences in accommodative lag, AA, or phoria between the groups (all P > 0.05). The HAL and SAL groups had reduced stereoacuity compared to the SVL group at baseline (70' vs. 60' vs. 50', P = 0.005), but no difference was observed at 12 months (70' vs. 70' vs. 70', P = 0.11).
HAL and SAL have no significant influence on accommodation and phoria except had larger AMF than SVL. Scotopic VA and low-contrast VA are reduced with short-term HAL and SAL use but recovered to be at same level with the SVL after 1 year of use. Trial registration Chinese Clinical Trial Registry: ChiCTR1800017683. Registered on 9 August 2018. http://www.chictr.org.cn/showproj.aspx?proj=29789.
利用一项随机对照临床试验的数据，研究采用高度非球面微透镜（HAL）和轻度非球面微透镜（SAL）的近视控制眼镜片对视觉功能和视觉质量的短期及长期影响。
这是一项前瞻性、随机、对照、双盲研究；170名8至13岁的近视儿童被随机分配至HAL组、SAL组或单光眼镜片（SVL）组。在佩戴镜片10分钟、6个月和12个月后，测量明视和暗视条件下高（100%）对比度和低（10%）对比度时的远、近视力（VA）、近隐斜、立体视锐度、调节滞后、微波动（AMFs）、幅度（AA）。
共有161名受试者在12个月内完成了所有随访并纳入分析。佩戴10分钟后，HAL组和SAL组的暗视和低对比度VA低于SVL组（HAL组和SAL组不同VA下分别下降0.03 - 0.08 logMAR和0.01 - 0.04 logMAR，均P < 0.05）。12个月时VA下降得到恢复，因为HAL组和SAL组的VA有显著改善，三组之间VA无差异（均P > 0.05）。HAL组和SAL组的AMFs显著大于SVL组（基线时HAL组对SAL组对SVL组：0.21±0.08 D对0.16±0.05 D对0.15±0.06 D，12个月时0.19±0.07 D对0.17±0.05 D对0.13±0.07 D，均P < 0.05）。各组之间在调节滞后、AA或隐斜方面无显著差异（均P > 0.05）。与SVL组相比，HAL组和SAL组在基线时立体视锐度降低（70'对60'对50'，P = 0.005），但12个月时未观察到差异（70'对70'对70'，P = 0.11）。
HAL和SAL对调节和隐斜无显著影响，只是AMF比SVL大。短期使用HAL和SAL会降低暗视VA和低对比度VA，但使用1年后恢复到与SVL相同水平。试验注册中国临床试验注册中心：ChiCTR1800017683。于2018年8月9日注册。http://www.chictr.org.cn/showproj.aspx?proj=29789 。
