Characteristics of responders to atropine 0.01% as treatment in Asian myopic children

Lee, Lung-Chi; Hsieh, Meng-Wei; Chen, Yi-Hao; Chen, Po-Liang; Chien, Ke‐Hung

doi:10.1038/s41598-022-10978-3

Cited by 5 publications

(9 citation statements)

References 41 publications

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“…Longer axial length is associated with increased risk of vision impairment from retinal detachment, myopic macular degeneration, and choroidal neovascularization. 7,8 Given these potential complications, many treatments to control myopia are being prescribed including topical atropine, [9][10][11][12][13][14][15][16][17][18][19][20][21] soft multifocal contact lenses, [21][22][23][24] overnight orthokeratology, 21,[25][26][27][28] specialized spectacle lenses, [27][28][29] increased outdoor activity, [30][31][32] and chromatic interventions. 33,34 Recently, low-dose atropine eye drops have also been used in Hong Kong to delay the onset of myopia in some children.…”

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confidence: 99%

Low-Dose 0.01% Atropine Eye Drops vs Placebo for Myopia Control

et al. 2023

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ImportanceControlling myopia progression is of interest worldwide. Low-dose atropine eye drops have slowed progression in children in East Asia.ObjectiveTo compare atropine, 0.01%, eye drops with placebo for slowing myopia progression in US children.Design, Setting, and ParticipantsThis was a randomized placebo-controlled, double-masked, clinical trial conducted from June 2018 to September 2022. Children aged 5 to 12 years were recruited from 12 community- and institution-based practices in the US. Participating children had low to moderate bilateral myopia (−1.00 diopters [D] to −6.00 D spherical equivalent refractive error [SER]).InterventionEligible children were randomly assigned 2:1 to 1 eye drop of atropine, 0.01%, nightly or 1 drop of placebo. Treatment was for 24 months followed by 6 months of observation.Main Outcome MeasuresAutomated cycloplegic refraction was performed by masked examiners. The primary outcome was change in SER (mean of both eyes) from baseline to 24 months (receiving treatment); other outcomes included change in SER from baseline to 30 months (not receiving treatment) and change in axial length at both time points. Differences were calculated as atropine minus placebo.ResultsA total of 187 children (mean [SD] age, 10.1 [1.8] years; age range, 5.1-12.9 years; 101 female [54%]; 34 Black [18%], 20 East Asian [11%], 30 Hispanic or Latino [16%], 11 multiracial [6%], 6 West/South Asian [3%], 86 White [46%]) were included in the study. A total of 125 children (67%) received atropine, 0.01%, and 62 children (33%) received placebo. Follow-up was completed at 24 months by 119 of 125 children (95%) in the atropine group and 58 of 62 children (94%) in the placebo group. At 30 months, follow-up was completed by 118 of 125 children (94%) in the atropine group and 57 of 62 children (92%) in the placebo group. At the 24-month primary outcome visit, the adjusted mean (95% CI) change in SER from baseline was −0.82 (−0.96 to −0.68) D and −0.80 (−0.98 to −0.62) D in the atropine and placebo groups, respectively (adjusted difference = −0.02 D; 95% CI, −0.19 to +0.15 D; P = .83). At 30 months (6 months not receiving treatment), the adjusted difference in mean SER change from baseline was −0.04 D (95% CI, −0.25 to +0.17 D). Adjusted mean (95% CI) changes in axial length from baseline to 24 months were 0.44 (0.39-0.50) mm and 0.45 (0.37-0.52) mm in the atropine and placebo groups, respectively (adjusted difference = −0.002 mm; 95% CI, −0.106 to 0.102 mm). Adjusted difference in mean axial elongation from baseline to 30 months was +0.009 mm (95% CI, −0.115 to 0.134 mm).Conclusions and RelevanceIn this randomized clinical trial of school-aged children in the US with low to moderate myopia, atropine, 0.01%, eye drops administered nightly when compared with placebo did not slow myopia progression or axial elongation. These results do not support use of atropine, 0.01%, eye drops to slow myopia progression or axial elongation in US children.Trial RegistrationClinicalTrials.gov Identifier: NCT03334253

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Low-Dose 0.01% Atropine Eye Drops vs Placebo for Myopia Control

et al. 2023

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“…We choose 0.02% atropine as a starting dose instead of 0.01% in low-risk group based upon below reasons: (1) 0.02% atropine had a better effect on myopia progression than 0.01% atropine, but 0.02% and 0.01% atropine showed similar effects on pupil diameter and accommodative amplitude (16). (2) Our prior study showed 0.01% atropine has a 58.63% responder rate in Taiwan myopic children but has better effect in certain children whose myopia better than −1.5D and age younger than 9 years when starting atropine treatment (17). About a choice of 0.05% atropine as a starting concentration in high risk group was due to that pupil dilation by 0.05% atropine is still tolerable in children between 4 and 12 years old (18).…”

Section: Discussionmentioning

confidence: 99%

Classification-Based Approaches to Myopia Control in a Taiwanese Cohort

et al. 2022

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PurposeMyopia is a disorder of growing prevalence in school-aged children worldwide, especially in Asia. Although low-dose atropine is recognized as an effective treatment to slow myopia progression, different studies have reported varying efficacies of treatment, and the optimal concentration of low-dose atropine remains an open question.MethodsA two-stage approach was conducted in this study. First, an observational study was conducted to plot the axial length growth curve for Taiwanese children. Second, an interventional 2-year study was performed in which different concentrations of low-dose atropine were applied based upon the risk-level status from the first stage.ResultsA total of 4,091 subjects, consisting of 2,105 boys (51.5%) and 1,986 girls (48.5%), were enrolled in the first stage to plot the axial growth curve for Taiwanese children aged between 3 and 16 years. The percentage of children with myopia increased from 2.3% in 4-year-olds to 88.0% in 16-year-olds. At the second stage, a total of 886 subjects [307 (34.65%) at low risk, 358 (40.41%) at moderate risk and 221 (24.94%) at high risk] were enrolled to receive low-dose atropine based upon the risk level (0.02, 0.03, and 0.05%, respectively). With this approach, the mean annual myopia progression was −0.33, −0.57, and −0.82 D in the low-risk, moderate-risk and high-risk groups, respectively. Applying annual myopic progression < -1.0 D as a criterion for responder, the responder rates were 95.77, 83.52, and 70.59% in the low-risk, moderate-risk, and high-risk groups, respectively.ConclusionsWe proposed a classification-based approach involving different concentrations of low-dose atropine based upon an individual's risk-level status. With this approach, myopic progression can be effectively controlled in patients without exposure to atropine side effects due to exposure to a higher dose than actually needed.

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“…While controversy surrounds baseline myopia as a progression factor, these differences could potentially influence the results, given that progression seems to occur faster in cases of moderate myopia compared to mild myopia 19 , 28 . Consequently, when evaluating the efficacy of 0.01% atropine treatment in children, it is vital to approach the comparison of these outcomes with caution, considering the diverse study designs and the baseline characteristics of the participants involved 29 .…”

Section: Discussionmentioning

confidence: 99%

Age-related results over 2 years of the multicenter Spanish study of atropine 0.01% in childhood myopia progression

Pérez-Flores,

Macías-Murelaga,

Flores

et al. 2023

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To evaluate the age-related efficacy and safety of atropine 0.01% eye drops over 2 years for myopia control in a multicentric pediatric Spanish cohort. A non-controlled, interventional, prospective multicenter study was conducted as an extension of the Spanish Group of Atropine Treatment for Myopia Control Study (GTAM 1). Children aged 6–14 years with myopia from − 2.00 to − 6.00 D, astigmatism < 1.50 D and documented annual myopic progression of at least − 0.50 D under cycloplegic examination were recruited. From the original cohort of 105 participants, 92 children who had been receiving atropine 0.01% eye drops once nightly in each eye for 1 year continued their participation in this extended study (GTAM 2). All the patients underwent a standardized quarterly follow-up protocol, which included measurements of best-corrected visual acuity (BCVA), cycloplegic autorefraction, axial length (AL), anterior chamber depth (ACD), and pupil diameter. The study sample was divided into three age groups: 6–8, 9–11, and 12–14 years old. The mean change in cycloplegic spherical equivalent (SE) and axial length (AL) during the 24 months of follow-up was analyzed. Correlations between SE and AL, as well as the distribution of annual progression, were evaluated. Adverse effects were recorded using a specific questionnaire. Finally, 81 children completed the follow-up and were included in the analysis. Over the 2-year period, the mean changes in SE and AL were − 0.88 ± 0.60 D and 0.49 ± 0.25 mm, respectively. Additionally, 51 patients (63%) experienced SE annual progression lower than − 0.50 D. The correlation between the progression of SE and AL during the total period of treatment was mild (r = − 0.36; p < 0.001). There were no differences between the first and the second year of treatment in the progression of SE (− 0.42 ± 0.41 D versus − 0.45 ± 0.39 D; p = 0.69) or AL (0.25 ± 0.16 mm versus 0.23 ± 0.14 mm; p = 0.43). Older patients (12–14 years old) showed less AL progression than younger children (6–8 years old): 0.36 ± 0.18 mm versus 0.59 ± 0.30 mm; p = 0.01. Adverse effects were mild, infrequent, and decreased over time. On average, the myopia progression in control groups from other published biannual studies exceeded that observed in our study. Over 2 years, atropine 0.01% demonstrated a safe treatment for controlling myopia progression in a multicentric cohort of Spanish children. The effect remained stable during this period. Older patients exhibited a more favorable response in terms of AL enlargement. However, further studies are needed to investigate the age-related effect of low-dose atropine in the Caucasian population.

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Characteristics of responders to atropine 0.01% as treatment in Asian myopic children

Cited by 5 publications

References 41 publications

Low-Dose 0.01% Atropine Eye Drops vs Placebo for Myopia Control

Low-Dose 0.01% Atropine Eye Drops vs Placebo for Myopia Control

Classification-Based Approaches to Myopia Control in a Taiwanese Cohort

Age-related results over 2 years of the multicenter Spanish study of atropine 0.01% in childhood myopia progression

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