Visual acuity, near phoria and accommodation in myopic children using spectacle lenses with aspherical lenslets: results from a randomized clinical trial.

OBJECTIVES

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.

METHODS

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.

RESULTS

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).

CONCLUSIONS

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.