A Randomized Noninferiority Trial ofWearing Adjustable Glasses versusStandard and Ready-made Spectaclesamong Chinese Schoolchildren

Congyao Y. Wang, Guoshan Zhang, Bobby Tang, Ling Jin, Wenyong Huang, Xiuqin Wang, Tingting Chen, Baixiang Xiao, Wenhui Zhu, Jun Wang, Zhongqiang Zhou, Zhizheng Tang, Yan Liang, Mabel Crescioni, David Wilson, Helen McAneney, Joshua D Silver, Bruce Moore, Nathan Congdon

Research output: Contribution to journalArticle

Abstract

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
Original languageEnglish
Pages (from-to)27-37
Number of pages11
JournalOphthalmology
Volume127
Issue number1
Early online date14 Aug 2019
DOIs
Publication statusPublished - Jan 2020

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Glass
Lenses
Visual Acuity
Ophthalmology
Refractive Errors
Observer Variation
Astigmatism
Quality of Life
Students

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Wang, Congyao Y. ; Zhang, Guoshan ; Tang, Bobby ; Jin, Ling ; Huang, Wenyong ; Wang, Xiuqin ; Chen, Tingting ; Xiao, Baixiang ; Zhu, Wenhui ; Wang, Jun ; Zhou, Zhongqiang ; Tang, Zhizheng ; Liang, Yan ; Crescioni, Mabel ; Wilson, David ; McAneney, Helen ; Silver, Joshua D ; Moore, Bruce ; Congdon, Nathan. / A Randomized Noninferiority Trial ofWearing Adjustable Glasses versusStandard and Ready-made Spectaclesamong Chinese Schoolchildren. In: Ophthalmology. 2020 ; Vol. 127, No. 1. pp. 27-37.
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abstract = "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",
author = "Wang, {Congyao Y.} and Guoshan Zhang and Bobby Tang and Ling Jin and Wenyong Huang and Xiuqin Wang and Tingting Chen and Baixiang Xiao and Wenhui Zhu and Jun Wang and Zhongqiang Zhou and Zhizheng Tang and Yan Liang and Mabel Crescioni and David Wilson and Helen McAneney and Silver, {Joshua D} and Bruce Moore and Nathan Congdon",
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Wang, CY, Zhang, G, Tang, B, Jin, L, Huang, W, Wang, X, Chen, T, Xiao, B, Zhu, W, Wang, J, Zhou, Z, Tang, Z, Liang, Y, Crescioni, M, Wilson, D, McAneney, H, Silver, JD, Moore, B & Congdon, N 2020, 'A Randomized Noninferiority Trial ofWearing Adjustable Glasses versusStandard and Ready-made Spectaclesamong Chinese Schoolchildren', Ophthalmology, vol. 127, no. 1, pp. 27-37. https://doi.org/10.1016/j.ophtha.2019.08.002

A Randomized Noninferiority Trial ofWearing Adjustable Glasses versusStandard and Ready-made Spectaclesamong Chinese Schoolchildren. / Wang, Congyao Y.; Zhang, Guoshan; Tang, Bobby; Jin, Ling; Huang, Wenyong; Wang, Xiuqin; Chen, Tingting; Xiao, Baixiang; Zhu, Wenhui; Wang, Jun; Zhou, Zhongqiang; Tang, Zhizheng ; Liang, Yan; Crescioni, Mabel; Wilson, David; McAneney, Helen; Silver, Joshua D; Moore, Bruce; Congdon, Nathan.

In: Ophthalmology, Vol. 127, No. 1, 01.2020, p. 27-37.

Research output: Contribution to journalArticle

TY - JOUR

T1 - A Randomized Noninferiority Trial ofWearing Adjustable Glasses versusStandard and Ready-made Spectaclesamong Chinese Schoolchildren

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

Y1 - 2020/1

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

VL - 127

SP - 27

EP - 37

JO - Ophthalmology

JF - Ophthalmology

SN - 0161-6420

IS - 1

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