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Ophthalmology Aug 2021To investigate the effect of age at treatment and other factors on treatment response to atropine in the Low-Concentration Atropine for Myopia Progression (LAMP) Study. (Randomized Controlled Trial)
Randomized Controlled Trial
PURPOSE
To investigate the effect of age at treatment and other factors on treatment response to atropine in the Low-Concentration Atropine for Myopia Progression (LAMP) Study.
DESIGN
Secondary analysis from a randomized trial.
PARTICIPANTS
Three hundred fifty children aged 4 to 12 years who originally were assigned to receive 0.05%, 0.025%, or 0.01% atropine or placebo once daily, and who completed 2 years of the LAMP Study, were included. In the second year, the placebo group was switched to the 0.05% atropine group.
METHODS
Potential predictive factors for change in spherical equivalent (SE) and axial length (AL) over 2 years were evaluated by generalized estimating equations in each treatment group. Evaluated factors included age at treatment, gender, baseline refraction, parental myopia, time outdoors, diopter hours of near work, and treatment compliance. Estimated mean values and 95% confidence intervals (CIs) of change in SE and AL over 2 years also were generated.
MAIN OUTCOME MEASURES
Factors associated with SE change and AL change over 2 years were the primary outcome measures. Associated factors during the first year were secondary outcome measures.
RESULTS
In 0.05%, 0.025%, and 0.01% atropine groups, younger age was the only factor associated with SE progression (coefficient of 0.14, 0.15, and 0.20, respectively) and AL elongation (coefficient of -0.10, -0.11, and -0.12, respectively) over 2 years; the younger the age, the poorer the response. At each year of age from 4 to 12 years across the treatment groups, higher-concentration atropine showed a better treatment response, following a concentration-dependent effect (P <0.05 for each age group). In addition, the mean SE progression in 6-year-old children receiving 0.05% atropine (-0.90 diopter [D]; 95% CI, -0.99 to -0.82) was similar to that of 8-year-old children receiving 0.025% atropine (-0.89 D; 95% CI, -0.94 to -0.83) and 10-year-old children receiving 0.01% atropine (-0.92 D; 95% CI, -0.99 to -0.85). All concentrations were well tolerated in all age groups.
CONCLUSIONS
Younger age is associated with poor treatment response to low-concentration atropine at 0.05%, 0.025%, and 0.01%. Among concentrations studied, younger children required the highest 0.05% concentration to achieve similar reduction in myopic progression as older children receiving lower concentrations.
Topics: Administration, Ophthalmic; Age Factors; Atropine; Axial Length, Eye; Child; Child, Preschool; Double-Blind Method; Female; Humans; Male; Mydriatics; Myopia, Degenerative; Ophthalmic Solutions; Refraction, Ocular; Surveys and Questionnaires; Treatment Outcome; Visual Acuity
PubMed: 33422558
DOI: 10.1016/j.ophtha.2020.12.036 -
Chembiochem : a European Journal of... Apr 2021The tropane alkaloids (TAs) hyoscyamine and scopolamine function as acetylcholine receptor antagonists and are used clinically as parasympatholytics to treat... (Review)
Review
The tropane alkaloids (TAs) hyoscyamine and scopolamine function as acetylcholine receptor antagonists and are used clinically as parasympatholytics to treat neuromuscular disorders in humans. While TAs are synthesized in a small subset of plant families, these specialized metabolites are only accumulated in limited quantities in plant organs. The complex chemical structures of these compounds make their industrial production by chemical synthesis very challenging, Therefore, the supply of these TAs still relies on intensive farming of Duboisia shrubs in tropical countries. Many adverse factors such as climate fluctuations and pandemics can thus influence annual world production. Based on the landmark microbial production of the antimalarial semi-synthetic artemisinin, the Smolke group recently developed a yeast cell factory capable of de novo synthesizing hyoscyamine and scopolamine, thus paving the way for an alternative production of these compounds.
Topics: Cholinergic Antagonists; Duboisia; Humans; Hyoscyamine; Molecular Structure; Scopolamine
PubMed: 33215811
DOI: 10.1002/cbic.202000757 -
Graefe's Archive For Clinical and... May 2020This review discusses the rapid rise of myopia among school-age children in East and Southeast Asia during the last 60 years. It describes the history, epidemiology,... (Review)
Review
This review discusses the rapid rise of myopia among school-age children in East and Southeast Asia during the last 60 years. It describes the history, epidemiology, and presumed causes of myopia in Asia, but also in Europe and the United States. The recent myopia boom is attributed primarily to the educational pressure in Asian countries, which prompts children to read for long hours, often under poor lighting and on computer screens. This practice severely limits the time spent outdoors and reduces exposure to sunlight and far vision. As a consequence, the eyes grow longer and become myopic. In a breakthrough study in Taiwan, it has been found that by increasing the time spent outdoors, the incidence of new myopia cases was reduced to half when children were sent onto the schoolyard for at least 2 h daily. This protection is attributed to the light-induced retinal dopamine, which blocks the abnormal growth of the eyeball. Once myopia has set in, low-dose atropine and orthokeratology have shown positive results in slowing myopia progression. Also, prismatic bifocal lenses and specially designed multifocal soft contact lenses have recently been tested with promising results. Treatment, however, must be initiated early as the disease progresses once it has started, thereby enhancing the risk for severe visual impairment and ultimately blindness.
Topics: Asia; Asian People; Atropine; Humans; Incidence; Leisure Activities; Mydriatics; Myopia; Orthokeratologic Procedures; Sunlight
PubMed: 31873785
DOI: 10.1007/s00417-019-04555-0 -
JPMA. the Journal of the Pakistan... Mar 2023The purpose of this study was to investigate the effect of 0.01% Atropine eye drops on diopter and optic axis in adolescents and children with myopia. A total of 164... (Randomized Controlled Trial)
Randomized Controlled Trial
The purpose of this study was to investigate the effect of 0.01% Atropine eye drops on diopter and optic axis in adolescents and children with myopia. A total of 164 children with myopia were randomly divided into two groups, Group A and Group B with 82 patients in each group, according to the digital table method. Group A was treated with 0.01% Atropine eye drops, while Group B was treated with single vision lenses. Before the treatment, there was no significant difference in diopter and axial length between the two groups (P=0.624 and P=0.123). After 12 months of treatment, the diopter and axial length of Group A were lower than those of Group B (P < 0.001 and P = 0.005). There were no obvious adverse reactions during corrective therapy in the two groups. The results show that compared with single vision lenses, 0.01% Atropine is more effective in correcting myopia, and may control the increase of optic axis in adolescents and children with myopia, in a better way, with high safety..
Topics: Humans; Child; Adolescent; Atropine; Myopia; Ophthalmic Solutions; Eyeglasses; Refraction, Ocular; Disease Progression
PubMed: 36932775
DOI: 10.47391/JPMA.6241 -
Clinical & Experimental Optometry Jul 2022All eye health care practitioners should know how to control myopia.
CLINICAL RELEVANCE
All eye health care practitioners should know how to control myopia.
BACKGROUND
Investigating the adjunctive effects of orthokeratology and 0.01% atropine eye drops on controlling the progression of myopia in Chinese children.
METHODS
The prospective study included Chinese children aged 8 to 13 years having a spherical equivalent refractive error ranging from -2.00 to -5.00 D. Participants were categorised into two groups: combination group (orthokeratology and 0.01% atropine) or atropine group (0.01% atropine). The axial length and spherical equivalent refraction were measured at baseline and every three months post-treatment and compared over two years.
RESULTS
The combinaion and atropine groups comprised 20 and 22 participants. Following two years of treatment, the average spherical equivalent refraction change was 0.88 ± 0.31 D and 1.14 ± 0.63 D in the combination group and atropine group, respectively (P = 0.026), with an average increment in axial length of 0.50 ± 0.17 mm and 0.61 ± 0.21 mm, respectively (P = 0.091). In the atropine group, increased axial length was positively correlated with baseline spherical equivalent refraction (P = 0.018) and negatively correlated with baseline age (P = 0.003). However, these correlations were not observed in the combination group. In the subgroup of subjects aged 8-10 years and another subgroup of subjects with shorter initial axial length (22.00 to 24.50 mm), the changes in axial length over two years were significantly smaller in the combination group than the atropine group.
CONCLUSION
Orthokeratology and 0.01% atropine eye drops combination therapy were found to be more effective in reducing progression of myopia, as measured through spherical equivalent refraction changes, than atropine monotherapy in children over two years. Combinatorial therapy was more effective in controlling the elongation of axial length in children with younger baseline age or shorter baseline axial length.
Topics: Adolescent; Atropine; Axial Length, Eye; Child; China; Humans; Myopia; Ophthalmic Solutions; Orthokeratologic Procedures; Prospective Studies; Refraction, Ocular
PubMed: 34228946
DOI: 10.1080/08164622.2021.1943318 -
BMC Ophthalmology Oct 2023To investigate the efficacy and safety of 0.1% and 0.01% low-dose atropine eye drops in reducing myopia progression in Danish children. (Randomized Controlled Trial)
Randomized Controlled Trial
Safety and efficacy of 0.01% and 0.1% low-dose atropine eye drop regimens for reduction of myopia progression in Danish children: a randomized clinical trial examining one-year effect and safety.
BACKGROUND
To investigate the efficacy and safety of 0.1% and 0.01% low-dose atropine eye drops in reducing myopia progression in Danish children.
METHODS
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 followed by 0.01% for six months (loading dose group, Number (N) = 33), 0.01% for twelve months (0.01% group, N = 32) or vehicle for twelve months (placebo, N = 32). Primary outcomes were axial length and spherical equivalent refraction. Secondary outcomes included adverse events and reactions, choroidal thickness and ocular biometry. Outcomes were measured at baseline and three-month intervals. Data was analyzed with linear-mixed model analysis according to intention-to-treat.
RESULTS
Mean axial elongation was 0.10 mm less (95% confidence interval (CI): 0.17; 0.02, adjusted-p = 0.06) in the 0.1% loading dose and 0.07 mm less (95% CI: 0.15; 0.00, adjusted-p = 0.16) in the 0.01% group at twelve months compared to placebo. Mean spherical equivalent refraction progression was 0.24 D (95% CI: 0.05; 0.42) less in the loading dose and 0.19 D (95% CI: 0.00; 0.38) less in the 0.01% groups at twelve months, compared to placebo (adjusted-p = 0.06 and 0.14, respectively). A total of 108 adverse events were reported during the initial six-month loading dose period, primarily in the loading dose group, and 14 were reported in the six months following dose switching, all deemed mild except two serious adverse events, unrelated to the intervention.
CONCLUSIONS
Low-dose atropine eye drops are safe over twelve months in otherwise healthy children. There may be a modest but clinically relevant reduction in myopia progression in Danish children after twelve months treatment, but the effect was statistically non-significant after multiple comparisons adjustment. After dose-switching at six months the loading dose group approached the 0.01% group, potentially indicating an early "rebound-effect".
TRIAL REGISTRATION
this study was registered in the European Clinical Trials Database (EudraCT, number: 2018-001286-16) 05/11/2018 and first posted at www.
CLINICALTRIALS
gov (NCT03911271) 11/04/2019, prior to initiation.
Topics: Child; Humans; Atropine; Ophthalmic Solutions; Myopia; Refraction, Ocular; Denmark; Disease Progression; Axial Length, Eye
PubMed: 37904082
DOI: 10.1186/s12886-023-03177-9 -
Indian Journal of Ophthalmology May 2023To investigate the change in ocular parameters of anisomyopic children treated with 0.01% atropine.
PURPOSE
To investigate the change in ocular parameters of anisomyopic children treated with 0.01% atropine.
METHODS
This retrospective study analyzed the data of anisomyopic children who underwent comprehensive examination at a tertiary eye center in India. Anisomyopic subjects (difference of ≥1.00 D) of age 6-12 years who were treated with 0.01% atropine or prescribed regular single vision spectacle and had follow-ups of more than 1 year were included.
RESULTS
Data from 52 subjects were included. No difference was observed in the mean rate of change of spherical equivalent (SE) of more myopic eyes between 0.01% atropine (-0.56 D; 95% confidence interval [CI]: -0.82, -0.30) and single vision lens wearers (-0.59 D; 95% CI: -0.80, -0.37; P = 0.88). Similarly, insignificant change in the mean SE of less myopic eyes was noted between the groups (0.01% atropine group, -0.62 D; 95% CI: -0.88, -0.36 vs. single vision spectacle wearer group, -0.76 D; 95% CI: -1.00, -0.52; P = 0.43). None of the ocular biometric parameters showed any difference between the two groups. Though anisomyopic cohort treated with 0.01% atropine revealed a significant correlation between the rate of change of mean SE and axial length in both eyes (more myopic eyes, r = -0.58; P = 0.001 and less myopic eyes, r = -0.82; P < 0.001) compared to single vision spectacle wearer group, the change was not significant.
CONCLUSION
Administration of 0.01% atropine had minimal effect on reducing the rate of myopia progression in anisomyopic eyes.
Topics: Humans; Child; Atropine; Mydriatics; Retrospective Studies; Eye; Refraction, Ocular; Myopia; Disease Progression; Axial Length, Eye
PubMed: 37203091
DOI: 10.4103/IJO.IJO_2762_22 -
Scientific Reports Nov 2021Four hundred myopic children randomly received atropine 0.02% (n = 138) or 0.01% (n = 142) in both eyes once-nightly or only wore single-vision spectacles... (Clinical Trial)
Clinical Trial Randomized Controlled Trial
Four hundred myopic children randomly received atropine 0.02% (n = 138) or 0.01% (n = 142) in both eyes once-nightly or only wore single-vision spectacles (control group) (n = 120) for 2 years. Spherical equivalent refractive error (SER), axial length (AL), pupil diameter (PD), and amplitude of accommodation (AMP) were measured every 4 months. After 2 years, the SER changes were - 0.80 (0.52) D, - 0.93 (0.59) D and - 1.33 (0.72) D and the AL changes were 0.62 (0.29) mm, 0.72 (0.31) mm and 0.88 (0.35) mm in the 0.02% and 0.01% atropine groups and control group, respectively. There were significant differences between changes in SER and AL in the three groups (all P < 0.001). The changes in SER and AL in the 2nd year were similar to the changes in the 1st year in the three groups (all P > 0.05). From baseline to 2 years, the overall decrease in AMP and increase in PD were not significantly different in the two atropine groups, whereas the AMP and PD in the control group remained stable (all P > 0.05). 0.02% atropine had a better effect on myopia control than 0.01% atropine, and its effects on PD and AMP were similar to 0.01% atropine. 0.02% or 0.01% atropine controlled myopia progression and AL elongation synchronously and had similar effects on myopia control each year.
Topics: Atropine; Case-Control Studies; Child; Disease Management; Female; Humans; Male; Mydriatics; Myopia, Degenerative; Refraction, Ocular; Treatment Outcome
PubMed: 34782708
DOI: 10.1038/s41598-021-01708-2 -
Journal of Biomaterials Applications May 2023Myopia, also known as nearsightedness, is one of the prime reasons for vision impairment worldwide. Atropine in topical ophthalmic solutions (e.g., 0.01% atropine...
Myopia, also known as nearsightedness, is one of the prime reasons for vision impairment worldwide. Atropine in topical ophthalmic solutions (e.g., 0.01% atropine sulfate eye drops) is the primary medical treatment for controlling myopia, especially for pseudomyopia or true myopia in rapid progress. However, aqueous atropine solution is unstable and easily breaks down to tropic acid, which will result in vision blur. Drug-eluting contact lenses (CLs) have been explored as a potentially superior alternative to effectively control the drug release and improve the drug efficacy. In this work, an atropine-eluting contact lens was developed by encapsulating an atropine implant in a silicon-based contact lens, towards functioning in vision correction and controlling myopia. The safety and effectiveness of this atropine-eluting contact lens were verified with rabbit and guinea pig models. The results showed that the lenses reduced the side effects like mydriasis and no other adverse events were observed in rabbit eyes. More importantly, atropine-loaded lenses could effectively delay the progress of form-deprivation myopia with guinea pig eyes as the model. Thus, we concluded that atropine-eluting CLs prepared by implantation technology may be an option for the treatment of myopia.
Topics: Animals; Guinea Pigs; Rabbits; Atropine; Silicones; Myopia; Contact Lenses; Ophthalmic Solutions
PubMed: 37083186
DOI: 10.1177/08853282231166858 -
The British Journal of Ophthalmology Nov 2019Myopia is a major cause of visual impairment. Its prevalence is growing steadily, especially in East Asia. Despite the immense disease and economic burden, there are... (Review)
Review
Myopia is a major cause of visual impairment. Its prevalence is growing steadily, especially in East Asia. Despite the immense disease and economic burden, there are currently no Food and Drug Administration-approved drugs for myopia. This review aims to summarise pharmaceutical interventions of myopia at clinical and preclinical stages in the last decade and discuss challenges for preclinical myopia drugs to progress to clinical trials. Atropine and oral 7-methylxanthine are shown to reduce myopia progression in human studies. The former has been extensively studied and is arguably the most successful medication. However, it has side effects and trials on low-dose atropine are ongoing. Other pharmaceutical agents being investigated at a clinical trial level include ketorolac tromethamine, oral riboflavin and BHVI2 (an experimental drug). Since the pathophysiology of myopia is not fully elucidated, numerous drugs have been tested at the preclinical stage and can be broadly categorised based on the proposed mechanisms of myopisation, namely antimuscarinic, dopaminergic, anti-inflammatory and more. However, several agents were injected intravitreally or subconjunctivally, hindering their progress to human trials. Furthermore, with atropine being the most successful medication available, future preclinical interventions should be studied in combination with atropine to optimise the treatment of myopia.
Topics: Administration, Oral; Animals; Anti-Inflammatory Agents, Non-Steroidal; Atropine; Clinical Trials as Topic; Disease Progression; Drug Evaluation, Preclinical; Drug Therapy; Humans; Ketorolac Tromethamine; Mydriatics; Myopia; Pharmaceutical Preparations; Riboflavin; Vitamin B Complex; Xanthines
PubMed: 31097440
DOI: 10.1136/bjophthalmol-2018-313798