Dataset Information

Effects of atropine 0.01% on refractive errors in children with myopia.

ABSTRACT:

Background

Little is known about changes in astigmatism during atropine treatment. We aimed to explore the effects of atropine 0.01% eye drops on both spherical and cylindrical refractive errors in myopic children.

Methods

Children aged 6-14 years with myopia ≥ -6.00 D and < -0.50 D, and total astigmatism > -2.00 D in at least one eye were enrolled. Subjects were randomised either to receive atropine 0.01% once nightly with single-vision lenses or simply to wear single-vision lenses and were followed up at 3-month intervals. Cycloplegic refraction and axial length were measured. The magnitude and direction of total astigmatism (TA), corneal astigmatism (CA), and residual astigmatism (RA) were evaluated.

Results

Overall, 119 eyes (69 eyes in the atropine group and 50 eyes in the control group) were included in the final analyses after 9 months. Atropine-treated eyes showed significantly less progression of myopia than did control eyes (spherical equivalent: -0.35 ± 0.33 vs. -0.56 ± 0.49 D, p = 0.001; axial length: 0.20 ± 0.19 vs. 0.33 ± 0.19 mm, p < 0.001). Compared with control eyes (-0.04 ± 0.23 D), a significant increase in TA was observed in the atropine-treated eyes (-0.14 ± 0.29 D); this was mainly attributed to the increase in CA (-0.17 ± 0.26 D) rather than the minor decrease in RA (0.02 ± 0.32 D).

Conclusions

Atropine 0.01% was effective in preventing myopia progression, whereas 9 months of atropine treatment resulted in a clinically small, but statistically significant increase in TA in myopic Chinese children.

SUBMITTER: Zhu X

PROVIDER: S-EPMC10415657 | biostudies-literature | 2023 Aug

REPOSITORIES: biostudies-literature

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Publications

Effects of atropine 0.01% on refractive errors in children with myopia.

Zhu Xingxue X Wang Yuliang Y Liu Yujia Y Ye Chaoying C Zhou Xingtao X Qu Xiaomei X

Heliyon 20230727 8

<h4>Background</h4>Little is known about changes in astigmatism during atropine treatment. We aimed to explore the effects of atropine 0.01% eye drops on both spherical and cylindrical refractive errors in myopic children.<h4>Methods</h4>Children aged 6-14 years with myopia ≥ -6.00 D and < -0.50 D, and total astigmatism > -2.00 D in at least one eye were enrolled. Subjects were randomised either to receive atropine 0.01% once nightly with single-vision lenses or simply to wear single-vision lens ...[more]

PMID: 37576220

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Project description:ImportanceExotropia and myopia are commonly coexistent. However, evidence is limited regarding atropine interventions for myopia control in children with myopia and intermittent exotropia (IXT).ObjectiveTo evaluate the efficacy and safety of 0.01% atropine eye drops on myopia progression, exotropia conditions, and binocular vision in individuals with myopia and IXT.Design, setting, and participantsThis placebo-controlled, double-masked, randomized clinical trial was conducted from December 2020 to September 2023. Children aged 6 to 12 years with basic-type IXT and myopia of -0.50 to -6.00 diopters (D) after cycloplegic refraction in both eyes were enrolled.InterventionParticipants were randomly assigned in a 2:1 ratio to 0.01% atropine or placebo eye drops administered in both eyes once at night for 12 months.Main outcomes and measuresThe primary outcome was change in cycloplegic spherical equivalent from baseline at 1 year. Secondary outcomes included change in axial length (AL), accommodative amplitude (AA), exotropia conditions, and binocular vision at 1 year.ResultsAmong 323 screened participants, 300 children (mean [SD] age, 9.1 [1.6] years; 152 male [50.7%]) were included in this study. A total of 200 children (66.7%) were in the atropine group, and 100 (33.3%) were in the placebo group. At 1 year, the 0.01% atropine group had slower spherical equivalent progression (-0.51 D vs -0.75 D; difference = 0.24 D; 95% CI, 0.11-0.37 D; P < .001) and AL elongation (0.31 mm vs 0.42 mm; difference = -0.11 mm; 95% CI, -0.17 to -0.06 mm; P < .001) than the placebo group. The mean AA change was -3.06 D vs 0.12 D (difference = -3.18 D; 95% CI, -3.92 to -2.44 D; P < .001) in the atropine and placebo groups, respectively. The 0.01% atropine group had a decrease in near magnitude of exodeviation whereas the placebo group had an increase (-1.25 prism diopters [PD] vs 0.74 PD; difference = -1.99 PD; 95% CI, -3.79 to -0.19 PD; P = .03). In the atropine vs placebo group, respectively, the incidence of study drug-related photophobia was 6.0% (12 of 200 participants) vs 8.0% (8 of 100 participants; difference = -2.0%; 95% CI, -9.4% to 3.7%; P = .51) and for blurred near vision was 6.0% (12 of 200 participants) vs 7.0% (7 of 100 participants) (difference = -1.0%; 95% CI, -8.2% to 4.5%; P = .74).Conclusions and relevanceThe findings of this randomized clinical trial support use of 0.01% atropine eye drops, although compromising AA to some extent, for slowing myopia progression without interfering with exotropia conditions or binocular vision in children with myopia and IXT.Trial registrationChinese Clinical Trial Registry Identifier: ChiCTR2000039827.

Project description:IntroductionOrthokeratology (OK) and low-concentration atropine are recommended approaches for controlling myopia. However, children with younger age and lower myopia are more likely to experience rapid axial progression during OK or atropine monotreatment. This study aimed to assess the efficacy of OK combined with low-concentration atropine for myopia control in children over 24 months and to determine whether the effect was sustainable.MethodsIn this retrospective study, we reviewed medical records of baseline and follow-up visits from children (7-14 years) applying OK for myopia control. Sixty-eight children receiving monoorthokeratology treatment (OK group) and 68 children who received 0.01% atropine in combination with orthokeratology simultaneously (AOK group) were included. A series of ophthalmic tests at baseline were conducted, and axial length (AL) was measured every 6 months. The comparison of AL change at different visits between the two groups was performed by repeated measures multivariate analyses of variance (RM-MANOVA).ResultsThere were no significant differences in baseline characters between the two groups (p > 0.05). The AL significantly increased over time in both groups (all p < 0.05), and the 2-year change in AOK was 0.16 mm (36%) lower than in OK (0.28 ± 0.22 mm versus 0.44 ± 0.34 mm, p = 0.001). Compared with OK group, the significant suppression of AL elongation in the AOK group was observed in 0-6, 6-12, and 12-18 month periods (suppression rate: 62.5%, 33.3%, 38.5%, respectively, p < 0.05), while there was no significant difference in the 18-24 month period (p = 0.105). The multiple regression analysis showed an interaction between age and treatment effect (interaction coefficient = 0.06, p = 0.040), indicating one year age decrease approximately associated with 0.06 mm increased retardation in AL elongation in the AOK group.ConclusionThe add-on effect of 0.01% atropine in OK wearers only occurred within 1.5 years, and younger children benefited more from the combination treatment.

Project description: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 and 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.

Dataset Information

Effects of atropine 0.01% on refractive errors in children with myopia.

Background

Methods

Results

Conclusions

Publications

Effects of atropine 0.01% on refractive errors in children with myopia.

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