A Randomized Controlled Trial of the Effect of 0.01% Atropine Eye Drops Combined with Auricular Acupoint Stimulation on Myopia Progression.
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ABSTRACT: Background
Use of 0.01% atropine eye drops (0.01% A) is one of the most common treatments for myopia control for children in Asia. Auricular acupoint stimulation (AAS) was reported to enhance the effect of higher-concentration atropine (0.25%, 0.125%) on myopia control. This study was designed to compare the effect of 0.01% A combined with AAS and 0.01% A alone on myopia progression and choroidal thickness in children.Methods
A total of 104 children were stratified by age and randomly assigned at 1 : 1 to receive 0.01% A or 0.01% A + AAS treatment for 6 months. Repeated measurements of cycloplegic spherical equivalent (SE) autorefraction, axial length (AL), and choroidal thickness were performed at baseline, 1 month, 3 months, and 6 months.Results
The adjusted mean SE change over the 6 months was -0.38 ± 0.04 D in the 0.01% A group (n = 50) and -0.25 ± 0.04 D in the 0.01% A + AAS group (n = 50), demonstrating a significant between-group difference (P = 0.02). There was no statistically significant difference in the change of AL and choroidal thickness between the two groups (both P > 0.05).Conclusions
Adjunctive AAS compared with 0.01% A monotherapy slowed myopic progression in Chinese children by a statistically small amount, but had no effect on axial elongation and choroidal thickness during this 6-month observation. The trial is registered with ChiCTR1900021316.
SUBMITTER: Kong XH
PROVIDER: S-EPMC8373503 | biostudies-literature |
REPOSITORIES: biostudies-literature
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Project description:IntroductionTopical atropine eye drops at low concentrations have been shown to slow myopia progression in East Asian studies. This study explored the effect of atropine 0.01% eye drops on controlling myopia progression in a multiethnic cohort of children in the USA.MethodsA multicenter retrospective case-control study (n = 198) quantified the effect of adding nightly atropine 0.01% eye drops to treatment as usual on the progression of childhood (ages 6-15 years) myopia. Cases included all children treated with atropine for at least 1 year. Controls were matched to cases on both age (± 6 months) and baseline spherical equivalent refraction (SER) (± 0.50 diopters, D) at treatment initiation. The primary endpoint was the average SER myopia progression after 1, 1.5, and 2 years of therapy. A secondary outcome was the percentage of subjects with a clinically significant worsening of myopia, defined as a greater than - 0.75 D SER increase in myopia.ResultsThe average baseline SERs for the atropine (n = 100) and control (n = 98) groups were similar (- 3.1 ± 1.9 D and - 2.8 ± 1.6 D, respectively) (p = 0.23). The average SER increase from baseline was significantly less for the atropine group than the control group at year 1 (- 0.2 ± 0.8 D compared with - 0.6 ± 0.4 D, p < 0.001) and at year 2 (- 0.3 ± 1.1 D compared with - 1.2 ± 0.7 D, p < 0.001). Secondary analysis at year 2 revealed that 80% of the control group vs. 37% of the atropine group experienced clinically significant worsening myopia of at least - 0.75 D (p < 0.001). There were no major safety issues reported in either group.ConclusionSimilar to results reported in Asia, atropine 0.01% eye drops significantly reduced myopia progression in a cohort of US children over 2 years of treatment.FundingNevakar, Inc. Plain language summary available for this article.
| S-EPMC6858408 | biostudies-literature
Project description:We investigated the two-year safety and efficacy of 0.1% loading dose and 0.01% low-dose atropine eye drops in Danish children for reduction in myopia progression in an investigator-initiated, placebo-controlled, double-masked, randomized clinical trial. Ninety-seven six- to twelve-year old myopic participants were randomized to 0.1% loading dose for six months and then 0.01% for eighteen months (loading dose group, N = 33), 0.01% for two years (0.01% group, N = 32) or placebo for two years (placebo, N = 32). Axial length (AL) and spherical equivalent refraction (SER) were primary outcomes. Secondary outcomes included adverse events and reactions, choroidal thickness, and other ocular biometrical measures. Outcomes were measured from baseline and at six-month intervals. Individual eyes nested by participant ID were analyzed with linear-mixed model analysis. Data were analyzed with intention-to-treat. Mean AL was 0.08 mm less (95% confidence interval (CI): -0.01; 0.17, p-value = 0.08) in the 0.1% loading dose and 0.10 mm less (95% CI: 0.01; 0.19, p-value = 0.02) in the 0.01% group after two years of treatment compared to placebo. Mean SER progression was 0.12 D (95% CI: -0.10; 0.33) less in the loading dose and 0.26 D (95% CI: 0.04; 0.48) less in the 0.01% groups after two years of treatment compared to placebo (p-value = 0.30 and 0.02, respectively). In total, 17 adverse events were reported in the second-year follow-up, and all were rated as mild. Adjusting for iris color did not affect treatment effect estimates. Intra-ocular pressure increased over two years comparably between all groups but remained within normal limits. Two-year treatment with 0.01% low-dose atropine eye drops is a safe and moderately efficacious intervention in Danish children for reducing myopia progression.
| S-EPMC10890135 | biostudies-literature
Project description:IntroductionThe purpose of this study was to investigate the efficacy and safety of consecutive use of 1% and 0.01% atropine compared with 0.01% atropine alone over 1 year.MethodsA total of 207 participants aged 6-12 years with myopia of - 0.50 to - 6.00 D in both eyes were enrolled in this randomized, controlled, non-masked trial and randomly assigned (1:1) to groups A and B. Group A received 1% atropine weekly and were tapered to 0.01% atropine daily at the 6-month visit, and group B received 0.01% atropine daily for 1 year.ResultsOf the 207 participants, 109 were female (52.7%) and the mean (± standard deviation) age was 8.92 ± 1.61 years. Ninety-one participants (87.5%) in group A and 80 participants (77.7%) in group B completed the 1-year treatment. Group A exhibited less refraction progression (- 0.53 ± 0.49 D vs. - 0.74 ± 0.52 D; P = 0.01) and axial elongation (0.26 ± 0.17 mm vs. 0.36 ± 0.21 mm; P < 0.001) over 1 year compared with group B. The changes in refraction (- 0.82 ± 0.45 D vs. - 0.46 ± 0.35 D; P < 0.001) and axial length (0.29 ± 0.12 mm vs. 0.17 ± 0.11 mm; P < 0.001) during the second 6 months in group A were greater than those in group B, with 72.5% of participants presenting refraction rebound. No serious adverse events were reported.ConclusionsThe 1-year results preliminarily suggest that consecutive use of 1% and 0.01% atropine confers an overall better effect in slowing myopia progression than 0.01% atropine alone, despite myopia rebound after the concentration switch. Both regimens were well tolerated. The long-term efficacy and rebound after the concentration switch and regimen optimization warrant future studies to determine.Trial registration numberClinical Trials.gov PRS (Registration No. NCT03949101).
| S-EPMC9521881 | biostudies-literature
Project description:BackgroundLittle 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.MethodsChildren 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.ResultsOverall, 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).ConclusionsAtropine 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.
| S-EPMC10415657 | biostudies-literature
Project description:Major studies demonstrating the inhibition of myopia in children and juveniles by low-dose atropine eye drops provide little information on the manufacturing process and the exact composition of the atropine dilutions. However, corneal penetration might significantly vary depending on preservatives, such as benzalkonium chloride (BAC), and the atropine concentration. Since there is a trade-off between side effects, stability, and optimal effects of atropine on myopia, it is important to gain better knowledge about intraocular atropine concentrations. We performed an ex vivo study to determine corneal penetration for different formulations. Atropine drops (0.01%) of different formulations were obtained from pharmacies and applied to the cornea of freshly enucleated pig eyes. After 10 min, a sample of aqueous humor was taken and atropine concentrations were determined after liquid-liquid extraction followed by high-performance liquid chromatography-tandem mass spectrometry (LC-MS/MS). The variability that originated from variations in applied drop size exceeded the differences between preserved and preservative-free formulations. The atropine concentration in the anterior chamber measured after 10 min was only 3.8 × 10-8 of its concentration in the applied eye drops, corresponding to 502.4 pM. Obviously, the preservative did not facilitate corneal penetration, at least ex vivo. In the aqueous humor of children's eyes, similar concentrations, including higher variability, may be expected in the lower therapeutic window of pharmacodynamic action.
| S-EPMC7914535 | biostudies-literature
Project description:Atropine eye drops and myopic retinal defocus each slow progression of myopia (short-sight). They also cause thickening of the choroid, and it has been suggested that the thickening is a precursor for reduced eye growth and slowed myopia progression. We investigated whether choroidal thickening due to optical defocus would add to thickening due to atropine when both were applied simultaneously. Addition would suggest that combining the two clinical treatments may improve efficacy of myopia control. We studied 20 children receiving 0.3% atropine daily for myopia control, over a period of 6 months. We imposed short periods of retinal defocus (1 h of myopic or hyperopic defocus (± 2.00D)) both before, and after 1 week and 3 and 6 months of atropine treatment. Prior to atropine, myopic or hyperopic defocus caused significantly thicker or thinner choroids respectively (± 12 µm, p < 0.001). After one week of atropine alone, thickness had increased (+ 21 µm; SD 17 µm; p < 0.001), and it increased further (by + 13 µm; SD 6 µm; p < 0.001) when exposed to myopic defocus. Atropine abolished choroidal thinning in response to hyperopic defocus. These effects remained the same after 3 and 6 months of atropine treatment. Our results show that additive effects of atropine and optical defocus are present at the level of the choroid, and suggest that combining optical and pharmaceutical treatments is likely to enhance efficacy of clinical myopia control.
| S-EPMC7591535 | biostudies-literature
Project description:BackgroundThe prevalence of myopia is increasing worldwide and is presently recognized as a major public health issue. Researchers and clinicians have been devoted in exploring appropriate clinical interventions to slow its progression in children. Mounting publications have proven that both orthokeratology (OK lens) and 0.01% atropine eyedrop can retard eye growth and myopia progression. However, it remains unclear whether the combination of OK lens and 0.01% atropine has the potential to magnify the effectiveness of myopia control. The present study aims to compare the myopia control efficiency of the combination of OK lens and 0.01% atropine with the monotherapy of OK lens in children.MethodsThe present study is a randomized, controlled, double-blind and multicenter clinical trial. A total of 96 children within 8-12 years old were recruited. These participants are treated with the combination of OK lens and 0.01% atropine eyedrop or the combination of OK lens and placebo eyedrop. Each group includes 48 participants. The inclusion criteria are as follows: myopia between - 1.00 and - 4.00 D in either eye and astigmatism of no more than 1.50 D. The follow-up time points will be 1, 6, 12, 18, and 24 months from randomization. The primary outcome is determined by the difference in axial length of the two groups, between the baseline and 24 months from randomization.DiscussionThe present randomized, controlled clinical trial would indicate the additive effects of the combination of OK lens and 0.01% atropine, and the extent of these effects, in retarding myopia progression and axial elongation in children.Trial registrationChinese Clinical Trial Registry (ChiCTR), ChiCTR1800018419 . Registered on 17 September 2018. http://www.chictr.org.cn/showproj.aspx?proj=29216.
| S-EPMC8633914 | biostudies-literature
Project description:ImportanceThe global prevalence of myopia is predicted to approach 50% by 2050, increasing the risk of visual impairment later in life. No pharmacologic therapy is approved for treating childhood myopia progression.ObjectiveTo assess the safety and efficacy of NVK002 (Vyluma), a novel, preservative-free, 0.01% and 0.02% low-dose atropine formulation for treating myopia progression.Design, setting, and participantsThis was a double-masked, placebo-controlled, parallel-group, randomized phase 3 clinical trial conducted from November 20, 2017, through August 22, 2022, of placebo vs low-dose atropine, 0.01% and 0.02% (2:2:3 ratio). Participants were recruited from 26 clinical sites in North America and 5 countries in Europe. Enrolled participants were 3 to 16 years of age with -0.50 diopter (D) to -6.00 D spherical equivalent refractive error (SER) and no worse than -1.50 D astigmatism.InterventionsOnce-daily placebo, low-dose atropine, 0.01%, or low-dose atropine, 0.02%, eye drops for 36 months.Main outcomes and measuresThe primary, prespecified end point was the proportion of participants' eyes responding to 0.02% atropine vs placebo therapy (<0.50 D myopia progression at 36 months [responder analysis]). Secondary efficacy end points included responder analysis for atropine, 0.01%, and mean change from baseline in SER and axial length at month 36 in a modified intention-to-treat population (mITT; participants 6-10 years of age at baseline). Safety measurements for treated participants (3-16 years of age) were reported.ResultsA total of 576 participants were randomly assigned to treatment groups. Of these, 573 participants (99.5%; mean [SD] age, 8.9 [2.0] years; 315 female [54.7%]) received trial treatment (3 participants who were randomized did not receive trial drug) and were included in the safety set. The 489 participants (84.9%) who were 6 to 10 years of age at randomization composed the mITT set. At month 36, compared with placebo, low-dose atropine, 0.02%, did not significantly increase the responder proportion (odds ratio [OR], 1.77; 95% CI, 0.50-6.26; P = .37) or slow mean SER progression (least squares mean [LSM] difference, 0.10 D; 95% CI, -0.02 D to 0.22 D; P = .10) but did slow mean axial elongation (LSM difference, -0.08 mm; 95% CI, -0.13 mm to -0.02 mm; P = .005); however, at month 36, compared with placebo, low-dose atropine, 0.01%, significantly increased the responder proportion (OR, 4.54; 95% CI, 1.15-17.97; P = .03), slowed mean SER progression (LSM difference, 0.24 D; 95% CI, 0.11 D-0.37 D; P < .001), and slowed axial elongation (LSM difference, -0.13 mm; 95% CI, -0.19 mm to -0.07 mm; P < .001). There were no serious ocular adverse events and few serious nonocular events; none was judged as associated with atropine.Conclusions and relevanceThis randomized clinical trial found that 0.02% atropine did not significantly increase the proportion of participants' eyes responding to therapy but suggested efficacy for 0.01% atropine across all 3 main end points compared with placebo. The efficacy and safety observed suggest that low-dose atropine may provide a treatment option for childhood myopia progression.Trial registrationClinicalTrials.gov Identifier: NCT03350620.
| S-EPMC10236322 | biostudies-literature
Project description:BackgroundThe retinal image quality derived from lower-order (LOA) and higher-order aberrations (HOA) for fixed 3-mm and photopic pupil diameters, in children undergoing combined 0.01% atropine and orthokeratology (AOK) versus those receiving orthokeratology alone (OK) over two years was evaluated.MethodsThe visual Strehl ratio based on the optical transfer function (VSOTF), derived from 2nd- to 4th-order terms (LOA and HOA combined), 2nd-order terms (LOA only), and 3rd- to 4th-order terms (HOA only) for fixed 3-mm and natural photopic pupil diameters, was compared between the two treatment groups. The individual Zernike coefficients for a fixed 3-mm pupil size of 2nd- to 4th-orders, root mean square (RMS) of LOA ([Formula: see text], [Formula: see text], and [Formula: see text] combined), HOA (3rd to 4th orders inclusive), and Coma ([Formula: see text] combined) were also compared between the two groups.ResultsRight eye data of 33 AOK and 35 OK participants were analysed. Under photopic conditions, significantly lower VSOTF based on HOA only was observed in the AOK group compared with that in the OK group at all post-treatment visits (all P < 0.05); however, interactions between HOA and LOA resulted in comparable overall retinal image quality (i.e., VSOTF based on LOA and HOA combined) between the two groups at all visits (all P > 0.05). For a fixed 3-mm pupil size, the VSOTF based on HOA only, LOA only, or HOA and LOA combined, were not different between the two groups (all P > 0.05). AOK participants had slower axial elongation (mean ± SD, 0.17 ± 0.19 mm vs. 0.35 ± 0.20 mm, P < 0.001), a larger photopic pupil size (4.05 ± 0.61 mm vs. 3.43 ± 0.41 mm, P < 0.001) than OK participants, over two years.ConclusionsHOA profile related to an enlarged pupil size may provide visual signal influencing eye growth in the AOK group.
| S-EPMC10234000 | biostudies-literature
Project description: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.
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