TY - JOUR
T1 - A Randomized Noninferiority Trial of Wearing Adjustable Glasses versus Standard and Ready-made Spectacles among Chinese School children
AU - Wang, Congyao Y.
AU - Zhang, Guoshan
AU - Tang, Bobby
AU - Jin, Ling
AU - Huang, Wenyong
AU - Wang, Xiuqin
AU - Chen, Tingting
AU - Xiao, Baixiang
AU - Zhu, Wenhui
AU - Wang, Jun
AU - Zhou, Zhongqiang
AU - Tang, Zhizheng
AU - Liang, Yan
AU - Crescioni, Mabel
AU - Wilson, David
AU - McAneney, Helen
AU - Silver, Joshua D
AU - Moore, Bruce
AU - Congdon, Nathan
PY - 2020/1/1
Y1 - 2020/1/1
N2 - Purpose:To compare wear of standard, adjustable, and ready-made glasses among children.Design:Randomized, controlled, open-label, noninferiority trial.Participants:Students aged 11 to 16 years with presenting visual acuity (VA)6/12 in both eyes, correctableto6/7.5, subjective spherical equivalent refractive error (SER)e1.0 diopters (D), astigmatism and anisome-tropia both<2.00 D, and no other ocular abnormalities.Methods:Participants were randomly allocated (1:1:1) to standard glasses, ready-made glasses, oradjustable glasses based on self-refraction. We recorded glasses wear on twice-weekly covert evaluation byhead teachers (primary outcome), self-reported and investigator-observed wear, best-corrected visual acuity(BCVA) (not prespecified), children’s satisfaction, and value attributed to glasses.Main Outcome Measure:Proportion of glasses wear on twice-weekly covert evaluation by head teachersover 2 months.Results:Among 379 eligible participants, 127 were allocated to standard glasses (mean age, 13.7 years;standard deviation [SD], 1.0 years; 54.3% were male), 125 to ready-made (mean age, 13.6; SD, 0.83; 45.6%), and127 to adjustable (mean age, 13.4 years; SD, 0.85; 54.3%). Mean wear proportion of adjustable glasses wassignificantly lower than for standard glasses (45% vs. 58%;P¼0.01), although the adjusted difference (90%confidence interval [CI],e19.0% toe3.0%) did not meet the prespecified inferiority threshold of 20%. Self-reported (90.2% vs. 84.8%,P¼0.64) and investigator-observed (44.1% vs. 33.9%,P¼0.89) wear did notdiffer between standard and adjustable glasses, nor did satisfaction with (P¼0.97) or value attributed to studyglasses (P¼0.55) or increase in quality of life (5.53 [SD, 4.47] vs. 5.68 [SD, 4.34] on a 100-point scale,P>0.30).Best-corrected visual acuity with adjustable glasses was better (P<0.001) than with standard glasses. Change inpower of study lenses at the end of the study (adjustable: 0.65 D, 95% CI, 0.52e0.79; standard, 0.01 D; 95% CI,e0.006 to 0.03,P<0.001) was greater for adjustable glasses, although interobserver variation in power mea-surements may explain this. Lens scratches and frame damage were more common with adjustable glasses,whereas lens breakage was less common than for standard glasses.Conclusions:Proportion of wear was lower with adjustable glasses, although VA was better and measures ofsatisfaction and quality of life were not inferior to standard glasses.Ophthalmology 2020;127:27-37ª2019 by theAmerican Academy of Ophthalmology
AB - Purpose:To compare wear of standard, adjustable, and ready-made glasses among children.Design:Randomized, controlled, open-label, noninferiority trial.Participants:Students aged 11 to 16 years with presenting visual acuity (VA)6/12 in both eyes, correctableto6/7.5, subjective spherical equivalent refractive error (SER)e1.0 diopters (D), astigmatism and anisome-tropia both<2.00 D, and no other ocular abnormalities.Methods:Participants were randomly allocated (1:1:1) to standard glasses, ready-made glasses, oradjustable glasses based on self-refraction. We recorded glasses wear on twice-weekly covert evaluation byhead teachers (primary outcome), self-reported and investigator-observed wear, best-corrected visual acuity(BCVA) (not prespecified), children’s satisfaction, and value attributed to glasses.Main Outcome Measure:Proportion of glasses wear on twice-weekly covert evaluation by head teachersover 2 months.Results:Among 379 eligible participants, 127 were allocated to standard glasses (mean age, 13.7 years;standard deviation [SD], 1.0 years; 54.3% were male), 125 to ready-made (mean age, 13.6; SD, 0.83; 45.6%), and127 to adjustable (mean age, 13.4 years; SD, 0.85; 54.3%). Mean wear proportion of adjustable glasses wassignificantly lower than for standard glasses (45% vs. 58%;P¼0.01), although the adjusted difference (90%confidence interval [CI],e19.0% toe3.0%) did not meet the prespecified inferiority threshold of 20%. Self-reported (90.2% vs. 84.8%,P¼0.64) and investigator-observed (44.1% vs. 33.9%,P¼0.89) wear did notdiffer between standard and adjustable glasses, nor did satisfaction with (P¼0.97) or value attributed to studyglasses (P¼0.55) or increase in quality of life (5.53 [SD, 4.47] vs. 5.68 [SD, 4.34] on a 100-point scale,P>0.30).Best-corrected visual acuity with adjustable glasses was better (P<0.001) than with standard glasses. Change inpower of study lenses at the end of the study (adjustable: 0.65 D, 95% CI, 0.52e0.79; standard, 0.01 D; 95% CI,e0.006 to 0.03,P<0.001) was greater for adjustable glasses, although interobserver variation in power mea-surements may explain this. Lens scratches and frame damage were more common with adjustable glasses,whereas lens breakage was less common than for standard glasses.Conclusions:Proportion of wear was lower with adjustable glasses, although VA was better and measures ofsatisfaction and quality of life were not inferior to standard glasses.Ophthalmology 2020;127:27-37ª2019 by theAmerican Academy of Ophthalmology
U2 - 10.1016/j.ophtha.2019.08.002
DO - 10.1016/j.ophtha.2019.08.002
M3 - Article
SN - 0161-6420
VL - 127
SP - 27
EP - 37
JO - Ophthalmology
JF - Ophthalmology
IS - 1
ER -
