Short-term effect of 0.01% atropine sulphate eye gel on myopia progression in children.
To investigate the effect of 0.01% atropine sulphate eye gel on myopia progression and axial elongation in a 6-month treatment in children. Totally 185 children aged 6-12y with binocular myopia of 3.0 D or less in both eyes were enrolled in this prospective cohort study. The atropine group (n=125) received one drop of 0.01% atropine sulphate eye gel in each eye before bedtime daily. The control group included 60 matched children without drug intervention during the same period. The spherical equivalent and axial length was recorded at baseline and the sixth month of treatment. The efficacy was evaluated by the change of the spherical equivalent and axial length. Adverse events were also recorded. The average spherical equivalent and axial length at baseline were not statistically significant between the atropine group (-1.64±0.80 D, 24.13±0.76 mm) and the control group (-1.59±0.94 D, 24.06±0.77 mm, P>0.05). After 6mo, there was significantly difference in the spherical equivalent progression between the atropine and the control group (-0.27±0.33 vs -0.60±0.35 D, P<0.001), with a relative reduction of 55.0% in myopia progression. The increase in axial elongation in the atropine group was significantly less than control group (0.19±0.14 vs 0.26±0.14 mm, P<0.001), with a relative reduction of 26.9% in axial length. The 84.4% and 38.4% of the eyes progressed by less than 0.50 D and remained stable in the atropine group, compared with 51.7% and 4.2% in the control group. No adverse events were observed. Atropine sulphate eye gel 0.01% can slow down myopia progression and axial elongation in children with a 6-month treatment.
- Research Article
4
- 10.1016/j.jfo.2024.104213
- Sep 1, 2024
- Journal Français d'Ophtalmologie
Posterior scleral reinforcement surgery effectively slows the rate of high myopic progression in children
- Research Article
6
- 10.1016/j.ophtha.2024.09.031
- Apr 1, 2025
- Ophthalmology
Multifocal Soft Contact Lenses for the Treatment of Myopia Progression in Children: A Report by the American Academy of Ophthalmology
- Research Article
- 10.52725/aocl.2025.24.2.84
- Jun 25, 2025
- Annals of Optometry and Contact Lens
Purpose: This study investigated the effects of low-dose atropine eye drops on myopia progression and axial length changes in pediatric patients with myopia for > 2 years.Methods: We retrospectively analyzed the medical records of patients with myopia who visited our hospital and underwent axial length measurement between January 2018 and June 2022. This study compared the outcomes of the atropine (106 patients) and control (38 patients) groups. Changes in spherical equivalent (SE) and axial length were analyzed over 2 years before and after using low-dose atropine eye drops.Results: The median change in axial length was 0.72 mm for the right eye (OD) and 0.71 mm for the left eye (OS) in the atropine group, whereas the control group showed a median change of 0.48 mm (OD) and 0.55 mm (OS). However, there was no significant difference between both groups (OD: p = 0.136; OS: p = 0.155). The median change in SE was 1.63 diopters (D) and 2.25 D in the atropine and control groups, respectively, with a significant difference between both groups (OD: p = 0.009; OS: p < 0.001) for 2 years.Conclusions: In pediatric and adolescent patients, the use of low-dose atropine eye drops for > 2 years appeared to delay changes in the SE, suggesting its potential effectiveness in slowing myopia progression.
- Research Article
112
- 10.1186/1471-2415-14-141
- Nov 24, 2014
- BMC Ophthalmology
BackgroundTo retrospectively compare axial elongation in children with different degrees of myopia wearing spectacles and undergoing ortho-k treatment.MethodsThe medical records of 128 patients who were fitted with spectacles or orthokeratology (ortho-k) lenses in our clinic between 2008 and 2009 were reviewed. Ortho-k group comprised 65 subjects and 63 subjects wearing spectacles were included in the control group. Subjects were also divided into low-myopia, moderate-myopia and high-myopia groups, based on the basic spherical equivalent refractive error. Axial length periodically measured over 2-year of lens wear and changes in axial length were compared between treatment groups and between subgroups with different degrees of myopia.ResultsThe control group exhibited more changes in axial length than the ortho-k group at both 12 months (0.39 ± 0.21 mm vs 0.16 ± 0.17 mm, p <0.001) and 24 months (0.70 ± 0.35 mm vs 0.34 ± 0.29 mm, p <0.001). Axial length elongation was estimated to be slower by about 51% in the ortho-k group. Similar results were found for the subgroups (49%, 59% and 46% reductions, respectively). In the group with low and moderate myopia, the annual increases in axial length were significantly different between the ortho-k and control groups during both the first ( Low myopia: 0.19 ± 0.17 mm vs 0.40 ± 0.18 mm, p = 0.001; Moderate myopia: 0.14 ± 0.18 mm vs 0.45 ± 0.22 mm, p <0.001) and second ( Low myopia: 0.18 ± 0.14 mm vs 0.32 ± 0.19 mm, p = 0.012; Moderate myopia: 0.18 ± 0.16 mm vs 0.34 ± 0.30 mm, p = 0.030) years. In the high myopia groups, significant differences were only found between the ortho-k and control groups during the first year (0.16 ± 0.18 mm vs 0.34 ± 0.22 mm, p = 0.004). The 2-year axial elongation was significantly associated with initial age (p <0.001) and treatment (p <0.001), but not with gender, initial refractive error, initial axial length, initial corneal curvature.ConclusionsThis 2-year study indicates that ortho-k contact lens wear is effective for reducing myopia progression in children with low, moderate and high myopia.
- Research Article
118
- 10.1007/s10384-006-0380-7
- Feb 9, 2007
- Japanese Journal of Ophthalmology
To study the safety and efficacy of topical 1% atropine eye ointment in retarding myopic progression in children with moderate to severe myopia. This was an interventional control study. Children (aged 5-10 years) with myopia of -3.00 diopters (D) or more were treated with 1% atropine ointment once daily for 1 year. Baseline and regular assessments of refractive errors by cycloplegic autorefraction and of axial length were done by ultrasound biometry, and the results were compared with data of control subjects. Twenty-three children (mean age: 7.4 +/- 1.6 years) with moderate to severe myopia, being treated in the Hong Kong Eye Hospital of the Chinese University of Hong Kong, were recruited into the atropine group, and 23 children from the same eye clinic were matched with the study subjects with respect to age, sex, and initial spherical equivalent refraction, as controls. The initial refractive errors were -5.18 +/- 2.05 D and -5.12 +/- 2.33 D in the atropine and the control groups, respectively (P = 0.934). Myopic progression was significantly less (P = 0.005) in the atropine group (+0.06 +/- 0.79 D) than in the control group (-1.19 +/- 2.48 D). Axial length increase was also significantly smaller in the atropine group (0.09 +/- 0.19 mm) than in the control group (0.70 +/- 0.63 mm) (P = 0.004). One child (4.3%) developed an allergic reaction. No other major adverse effects related to the treatment were noted. Topical 1% atropine ointment is a safe and effective treatment for retarding myopic progression in moderate to severe myopia. Further large-scale randomised controlled study with longer follow-up seems warranted.
- Research Article
163
- 10.1001/jamaophthalmol.2020.3820
- Oct 1, 2020
- JAMA Ophthalmology
Because studies have suggested that atropine might slow the progression of myopia in children, randomized clinical trials are warranted to understand this potential causal relationship. To evaluate the efficacy and safety of atropine, 0.01%, eyedrops on slowing myopia progression and axial elongation in Chinese children. This was a randomized, placebo-controlled, double-masked study. A total of 220 children aged 6 to 12 years with myopia of -1.00 D to -6.00 D in both eyes were enrolled between April 2018 and July 2018 at Beijing Tongren Hospital, Beijing, China. Cycloplegic refraction and axial length were measured at baseline, 6 months, and 12 months. Adverse events were also recorded. Patients were randomly assigned in a 1:1 ratio to atropine, 0.01%, or placebo groups to be administered once nightly to both eyes for 1 year. Mean changes and percentage differences in myopia progression and axial elongation between atropine, 0.01%, or placebo groups. Of 220 participants, 103 were girls (46.8%), and the mean (SD) age was 9.64 (1.68) years. The mean (SD) baseline refractive error and axial length were -2.58 (1.39) D and 24.59 (0.87) mm. Follow-up at 1 year included 76 children (69%) and 83 children (75%) allocated into the atropine, 0.01%, and placebo groups, respectively, when mean myopia progression was -0.49 (0.42) D and -0.76 (0.50) D in the atropine, 0.01%, and placebo groups (mean difference, 0.26 D; 95% CI, 0.12-0.41 D; P < .001), with a relative reduction of 34.2% in myopia progression. The mean (SD) axial elongation in the atropine, 0.01%, group was 0.32 (0.19) mm compared with 0.41 (0.19) mm in the placebo group (mean difference, 0.09 mm; 95% CI, 0.03-0.15 mm; P = .004), with relative reduction of 22.0% in axial elongation. Fifty-one percent and 13.2% of children progressed by at least 0.50 D and 1.00 D in the atropine, 0.01%, group, compared with 69.9% and 34.9% in the placebo group. No serious adverse events related to atropine were reported. While the clinical relevance of the results cannot be determined from this trial, these 1-year results, limited by approximately 70% follow-up, suggest that atropine, 0.01%, eyedrops can slow myopia progression and axial elongation in children and warrant future studies to determine longer-term results and potential effects on slowing sight-threatening pathologic changes later in life. http://www.chictr.org.cn Identifier: ChiCTR-IOR-17013898.
- Research Article
206
- 10.1002/14651858.cd004916.pub4
- Jan 13, 2020
- Cochrane Database of Systematic Reviews
Background Nearsightedness (myopia) causes blurry vision when looking at distant objects. Highly nearsighted people are at greater risk of several vision-threatening problems such as retinal detachments, choroidal atrophy, cataracts and glaucoma. Interventions that have been explored to slow the progression of myopia include bifocal spectacles, cycloplegic drops, intraocular pressure-lowering drugs, muscarinic receptor antagonists and contact lenses. The purpose of this review was to systematically assess the effectiveness of strategies to control progression of myopia in children.
- Research Article
7
- 10.1080/09286586.2023.2232462
- Aug 6, 2023
- Ophthalmic Epidemiology
Purpose Atropine eye drops have been shown to slow the progression of myopia, but there has been limited research on the effectiveness of 0.05% atropine in treating myopia. This study aimed to investigate the safety and efficacy of 0.05% atropine eye drops in controlling myopia in children. Methods The study included 424 participants aged 6 to 12 years between January 1, 2015, and January 1, 2021. Of these, 213 were randomly assigned to the 0.05% atropine group and 211 to the placebo group. The cycloplegic spherical equivalent (SE), axial length (AL), corneal curvature (K), and anterior chamber depth (ACD) were measured using IOLMaster. The lens power and corneal astigmatism were also determined. The changes in ocular biometric parameters were compared between the two groups, and the contributions of ocular characteristics to SE progression were calculated and compared. Results Over a 12-month period, the changes in spherical equivalent were −0.03 ± 0.28 and −0.32 ± 0.14 in the atropine and placebo groups, respectively (P = .01). The changes in axial length were 0.06 ± 0.11 and 0.17 ± 0.12, respectively (P = .01). At 18 and 24 months, there were significant differences in axial length and spherical equivalent between the atropine and placebo groups. Multiple regression models accounting for changes in AL, K, and lens magnification explained 87.23% and 98.32% of SE changes in the atropine and placebo groups, respectively. At 1 year (p = .01) and 2 years (p = .03), there were significant differences in photophobia between the atropine and placebo groups. Conclusions This two-year follow-up study demonstrates that 0.05% atropine eye drops are safe and effective in preventing the development of myopia in school-aged children.
- Research Article
8
- 10.3389/fpubh.2023.1074272
- Jan 26, 2023
- Frontiers in Public Health
To compare the myopic progression in children treated with 0. 01% atropine and those who discontinued atropine during the 2022-home quarantine in Shanghai. In this retrospective study, children aged 6-13 years with follow-up visits before (between January 2022 and February 2022) and after the lockdown (between July 2022 and August 2022) were included. Cycloplegic refraction and axial length (AL) were measured at both visits. The atropine group had continuous medication during the lockdown while the control group discontinued. The 0.01% atropine eyedrops were administered daily before bedtime. The types of spectacle lens were recorded: single vision (SV) spectacles or defocus incorporated multiple segments lenses (DIMS). In total, 41 children (81 eyes) in the atropine group and 32 children (64 eyes) in the control group were enrolled. No significant difference was found in the demographic characteristics, spherical diopter, spherical equivalent (SE), AL, and follow-up time between the two groups before the lockdown in 2022 (all p > 0.1). After the home confinement, a greater myopia progression was observed in the control group (-0.46 ± 0.42 D) compared to atropine group (-0.26 ± 0.37 D; p = 0.0023). Axial elongation was also longer in the control group than that in children sustained with atropine (0.21 ± 0.17 vs. 0.13 ± 0.15 mm, p = 0.0035). Moreover, there was no significant change of spherical diopter and SE during lockdown in the atropine + DIMS combined subgroup (0.03 ± 0.033 D for spherical diopter, p = 0.7261 and 0.08 ± 0.27 D for SE, p = 0.2042, respectively). However, significant myopic shift was observed in the atropine + SV subgroup during the quarantine time (-0.31 ± 0.39 D for SE and 0.15 ± 0.16 mm for AL, both p < 0.001). Children treated with 0.01% atropine had slower myopia progression during the lockdown period in Shanghai compared with children discontinued. Moreover, the effect of atropine on myopic prevention can be strengthened with DIMS lenses.
- Research Article
11
- 10.1007/s10384-023-01012-8
- Aug 7, 2023
- Japanese Journal of Ophthalmology
Having previously demonstrated the efficacy of 0.01% atropine eye drops for inhibiting progression of childhood myopia, we conducted additional analyses to assess post-treatment changes in myopia progression. Analysis of follow-up data from a previously reported randomized controlled trial METHODS: A mixed-effects model was used to compare intergroup changes in spherical equivalent (SE) and axial length (AL) at 1month and 12months after discontinuation of 2-year treatment with atropine or placebo in 167 school-age children. Follow-up measurements were available for 149 participants at 1month after discontinuation of treatment and for 51 participants at 12months after discontinuation. At 1month post-treatment, differences between the atropine and placebo groups in least squares (LS) mean changes in SE and AL, respectively, from 24 months were -0.06 diopters (D) (95% CI: -0.21, 0.08; P=.39) and 0.02 mm (95% CI: -0.05, 0.08; P=.60). At 12months post-treatment, intergroup differences (atropine vs placebo) in LS mean changes in SE and AL, respectively, were -0.13 D (95% CI: -0.35, 0.10; P=.26) and -0.02mm (95% CI: -0.12, 0.09; P=.75). LS mean changes in SE and AL from treatment discontinuation did not differ between the groups at 1 or 12months post-treatment. Axial elongation was significantly less in the atropine group than in the placebo group. The suppression effect obtained at 2years was maintained after 12months. The absence of intergroup differences in myopia progression since treatment cessation suggests that myopic rebound did not occur.
- Research Article
- 10.35749/journal.v49i1.100681
- Mar 14, 2023
- Ophthalmologica Indonesiana
Introduction: Myopia is major public health concern that has become increasingly common. Severe myopia has become one of the main causes of untreatable vision loss throughout the world, often due to its irreversible complications. Studies shows atropine can reduce myopia progression in children. Currently, there are no guidelines for the use of atropine specifically to control myopia progression. This study was made to review the efficacy of various atropine doses in controlling myopia progression. Methods: Literature searching was conducted in four online databases (PubMed, EBSCOhost, ScienceDirect, and Scopus. Search terms included were “Atropine” and “Myopia”. Validity was assessed using assessment tool from Cochrane. Efficacy was evaluated using myopia progression in spherical equivalent per year and axial lengthening per year. Results: Sixteen randomized controlled trial studies fulfilled our inclusion criteria and eligibility screening. Overall, atropine shows favorable results in spherical equivalent progression (D/year) compared to control, with SMD = -1.13, 95% CI (-0.58, -1.68). Less axial elongation (mm/year) was observed in atropine group, with SMD = -1.28, 95% CI (-0.18, -2.37). Atropine 0.01% concentration shows overall significantly better myopia progression and axial lengthening compared to control, with SMD = -0.76, 95% CI (-0.08, -1.44) and SMD = -0.63, 95% CI (-0.14, -1.12), respectively. Higher atropine doses showed larger effect sizes with higher occurrence of adverse effects. Conclusion: Atropine eye drops in various doses shows overall effective myopia control in spherical equivalent and axial lengthening. Atropine 0.01% has significant myopia progression inhibition with less adverse effects than higher doses.
- Research Article
19
- 10.1038/s41598-022-15686-6
- Jul 8, 2022
- Scientific Reports
This study aimed to evaluate the efficacy of 18-month 0.01% atropine in 61 myopic children (aged 7–10) and the relationship with central retinal response (by multifocal electroretinogram [mfERG]) in a double-masked randomized placebo-controlled clinical trial. Global-flash mfERG was measured at baseline, while cycloplegic spherical equivalent refraction (SER) and axial length (AL) were measured at baseline and at 6-month intervals. Annualized change in SER and AL were compared between atropine and control groups, and the relationships with baseline mfERG were evaluated. Changes in SER (−0.70 ± 0.39D vs. −0.66 ± 0.41D, p = 0.63) and AL (0.32 ± 0.16 mm vs. 0.30 ± 0.22 mm, p = 0.52) were similar in atropine and control groups. Interestingly, in the placebo group, mfERG amplitude was negatively correlated with axial elongation (Rp = −0.44, p = 0.03) as in our previous study. However, in the atropine group, an opposite trend was observed that axial elongation was positively correlated with mfERG amplitude (Ra = 0.37, p = 0.04). Annualized myopia progression demonstrated similar opposite effect between atropine and placebo groups but did not reach statistical significance. An ERG screening protocol may be warranted to identify suitable candidates to reduce the likelihood of an unfavorable treatment response by 0.01% atropine.
- Research Article
1
- 10.1186/s12886-025-04009-8
- Apr 17, 2025
- BMC Ophthalmology
BackgroundThe global prevalence of myopia is rising rapidly, with projections indicating that by 2050, half of the world’s population will be affected. High myopia is associated with an increased risk of sight-threatening complications, contributing to a substantial public health burden. Atropine 0.01% has been widely used for myopia control in non-Asian populations, supported by evidence demonstrating its efficacy. Myopi-X® lenses, designed to induce myopic defocus, represent an optical alternative to pharmacological intervention. Given that atropine requires monthly preparation, long-term adherence, and may cause mild side effects, (Myopi-X® Novax®) lenses offer a non-pharmacological option that may be preferable for some patients. This study compares the effectiveness of these two treatment strategies in comparison with single vision lenses to provide further insights into their role in myopia management.MethodsThis retrospective observational study was conducted at Acıbadem Hospital, Ankara, between September 2022 and September 2023. A total of 128 patients aged 5 to 16 years with myopia were included and divided into three groups: peripheral progressive addition lenses (Myopi-X® Novax®), atropine 0.01%, and single vision lenses. Baseline characteristics, including age, gender, and axial length, were recorded. Cycloplegic autorefraction and axial length measurements were performed, and statistical analyses were conducted to assess changes in spherical equivalent refraction and axial length over 12 months. Additionally, the potential effects of baseline axial length, gender, and age group on spherical equivalent progression and axial length elongation were evaluated.ResultsSignificant differences were observed among the treatment groups in changes in spherical equivalent refraction and axial length (p < 0.001). Both the Myopi-X® lenses and atropine 0.01% groups exhibited significantly less myopia progression compared to the single vision lenses group (p < 0.001 for both). However, no significant difference was observed between the Myopi-X® lenses and atropine 0.01% groups at 12 months (p = 0.79), and axial length changes remained comparable between these two groups (p = 0.76). Regarding potential confounding factors, age had a significant effect on spherical equivalent refraction progression, with older children experiencing less myopic progression (p = 0.02), whereas no significant effect was observed on axial length change (p = 0.11). Gender was not significantly associated with changes in spherical equivalent (p = 0.21) or axial length (p = 0.32). Similarly, baseline axial length showed no significant association with changes in spherical equivalent (p = 0.17) or axial length (p = 0.36).ConclusionBoth Myopi-X® lenses and atropine 0.01% effectively slowed myopia progression over 12 months compared to single vision lenses. Spherical equivalent progression and axial length elongation were comparable between these two treatment groups. Gender and baseline axial length did not significantly affect the outcomes, whereas older children exhibited less myopic progression in terms of spherical equivalent change. This study aimed to compare the clinical effectiveness of these two treatment strategies. Further studies with longer follow-up periods are required to evaluate the long-term sustainability of these effects.
- Research Article
3
- 10.1016/j.ophtha.2025.01.003
- Jun 1, 2025
- Ophthalmology
Behavioral Intervention with Eye-Use Monitoring to Delay Myopia Onset and Progression in Children: A Cluster Randomized Trial.
- Research Article
- 10.1007/s40123-025-01214-y
- Aug 19, 2025
- Ophthalmology and Therapy
IntroductionPrevious studies have suggested that premyopia shows high prevalence and high risk of progression to myopia among children. Therefore, the purpose of this study was to investigate the efficacy and safety of 0.01% atropine eye drops and novel positive Lenslet-ARray-Integrated spectacle lenses (LARI) in slowing myopia onset and myopic shift among children with premyopia in China.MethodsThis was a prospective randomized controlled trial. A total of 400 children aged 6–12 years with premyopia in both eyes were enrolled. Subjects were randomly divided into four groups in equal proportions: 0.01% atropine eye drops group (group A), LARI group (group S), combination group (group AS), and control group without any clinical intervention (group E). Measurements were conducted at baseline and at 3-, 6-, and 12-month follow-up. The incidence of myopia and the percentage of patients with fast myopic shift over 1 year were the primary outcomes. The secondary outcomes were changes in cycloplegic spherical equivalent refraction (SE) and axial length (AL). Changes in uncorrected visual acuity (UCVA), corneal curvature (CC), subfoveal choroidal thickness (SFCT), and intraocular pressure (IOP) were the exploratory outcomes. Adverse events were also recorded.ResultsThe incidence of myopia and the percentage of patients with fast myopic shift in groups A, S, and AS were significantly lower than those in group E. Treatment with 0.01% atropine, LARI, and their combination decreased myopia progression by 55.88%, 64.71%, and 77.94%, and axial elongation by 65.00%, 75.00%, and 77.50%, respectively. Further analyses were conducted based on age stratification. SFCT in intervention groups increased significantly. No serious adverse events were detected.ConclusionsThese 1-year results suggest that, combined with the progression of SE, the reduction in AL, and the increase in SFCT, 0.01% atropine and LARI can be used as effective and safe treatments for the prevention of myopia progression in children with premyopia. Combination therapy showed superior efficacy in this cohort, but long-term effects beyond 12 months remain unknown.Trial Registration: ChiCTR2500098887.Supplementary InformationThe online version contains supplementary material available at 10.1007/s40123-025-01214-y.