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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 -
Asia-Pacific Journal of Ophthalmology...
Topics: Humans; Atropine; Ophthalmic Solutions; Myopia; Mydriatics; Disease Progression; Refraction, Ocular
PubMed: 37523423
DOI: 10.1097/APO.0000000000000617 -
The Israel Medical Association Journal... Jul 2002Atropine is the drug of choice for treatment of organophosphate nerve agent and insecticide intoxication and has been used for this indication for several decades.... (Review)
Review
Atropine is the drug of choice for treatment of organophosphate nerve agent and insecticide intoxication and has been used for this indication for several decades. Adverse reactions to atropine may occur, and are of two types: toxic and allergic. Toxic reaction, the most common form, results from the anti-muscarinic effects of the drug. Since it is most probably related to interpersonal variation in sensitivity to atropine, toxic effects may appear at the usual therapeutic doses. The second type, allergic reaction, includes local manifestations, usually after the administration of eyedrops, and systemic reaction in the form of anaphylaxis. Since most patients manifest only a mild reaction, allergy testing is not performed and the prevalence of allergy to atropine is therefore not known. Severe allergic reaction to atropine is rare, as evidenced by the small number of case reports in the literature despite the drug's extensive use. Alternative anti-muscarinic drugs recommended for OP poisoning include glycopyrrolate and scopolamine. Glycopyrrolate is a peripheral anti-muscarinic drug that has been studied in comparison to atropine for many clinical indications, while scopolamine is an anti-muscarinic drug with both peripheral and central effects. An acceptable alternative regimen for patients with proven allergy to atropine is a combination of glycopyrrolate with centrally active drugs such as benzodiazepines or scopolamine.
Topics: Atropine; Drug Hypersensitivity; Glycopyrrolate; Humans; Muscarinic Antagonists; Organophosphate Poisoning; Scopolamine
PubMed: 12120467
DOI: No ID Found -
BMC Veterinary Research Apr 2021Topical ophthalmic atropine sulfate is an important part of the treatment protocol in equine uveitis. Frequent administration of topical atropine may cause decreased...
BACKGROUND
Topical ophthalmic atropine sulfate is an important part of the treatment protocol in equine uveitis. Frequent administration of topical atropine may cause decreased intestinal motility and colic in horses due to systemic exposure. Atropine pharmacokinetics are unknown in horses and this knowledge gap could impede the use of atropine because of the presumed risk of unwanted effects. Additional information could therefore increase safety in atropine treatment.
RESULTS
Atropine sulfate (1 mg) was administered in two experiments: In part I, atropine sulfate was administered intravenously and topically (manually as eye drops and through a subpalpebral lavage system) to six horses to document atropine disposition. Blood-samples were collected regularly and plasma was analyzed for atropine using UHPLC-MS/MS. Atropine plasma concentration was below lower limit of quantification (0.05 μg/L) within five hours, after both topical and IV administration. Atropine data were analyzed by means of population compartmental modeling and pharmacokinetic parameters estimated. The typical value was 1.7 L/kg for the steady-state volume of distribution. Total plasma clearance was 1.9 L/h‧kg. The bioavailability after administration of an ophthalmic preparation as an eye drop or topical infusion were 69 and 68%, respectively. The terminal half-life was short (0.8 h). In part II, topical ophthalmic atropine sulfate and control treatment was administered to four horses in two dosing regimens to assess the effect on gastro-intestinal motility. Borborygmi-frequency monitored by auscultation was used for estimation of gut motility. A statistically significant decrease in intestinal motility was observed after administration of 1 mg topical ophthalmic atropine sulfate every three hours compared to control, but not after administration every six hours. Clinical signs of colic were not observed under any of the treatment protocols.
CONCLUSIONS
Taking the plasma exposure after topical administration into consideration, data and simulations indicate that eye drops administrated at a one and three hour interval will lead to atropine accumulation in plasma over 24 h but that a six hour interval allows total washout of atropine between two topical administrations. If constant corneal and conjunctival atropine exposure is required, a topical constant rate infusion at 5 μg/kg/24 h offers a safe alternative.
Topics: Animals; Atropine; Biological Availability; Female; Gastrointestinal Motility; Half-Life; Horses; Injections, Intravenous; Male; Ophthalmic Solutions; Parasympatholytics
PubMed: 33827566
DOI: 10.1186/s12917-021-02847-4 -
Journal of Medical Toxicology :... Jun 2014Atropine is the mainstay of therapy in organophosphate (OP) toxicity, though research and consensus on dosing is lacking. In 2004, as reported by Eddleston et al. (J... (Comparative Study)
Comparative Study Review
Atropine is the mainstay of therapy in organophosphate (OP) toxicity, though research and consensus on dosing is lacking. In 2004, as reported by Eddleston et al. (J Toxicol Clin Toxicol 42(6):865-75, 2004), they noted variation in recommended regimens. We assessed revisions of original references, additional citations, and electronic sources to determine the current variability in atropine dosing recommendations. Updated editions of references from Eddleston et al.'s work, texts of Internal and Emergency Medicine, and electronic resources were reviewed for atropine dosing recommendations. For comparison, recommendations were assessed using the same mean dose (23.4 mg) and the highest dose (75 mg) of atropine as used in the original paper. Recommendations were also compared with the dosing regimen from the World Health Organization (WHO). Thirteen of the original recommendations were updated and 15 additional references were added giving a convenience sample of 28. Sufficient information to calculate time to targeted dose was provided by 24 of these samples. Compared to 2004, current recommendations have greatly increased the speed of atropinization with 13/24 able to reach the mean and high atropine dose within 30 min compared to 1/36 in 2004. In 2004, there were 13 regimens where the maximum time to reach 75 mg was over 18 h, whereas now, there are 2. While only one recommendation called for doubling the dose for faster escalation in 2004, 15 of the 24 current works include dose doubling. In 2004, Eddleston et al. called for an evidence-based guideline for the treatment of OP poisoning that could be disseminated worldwide. Many current recommendations can adequately treat patients within 1 h. While the WHO recommendations remain slow to treat patients with OP poisoning, other authorities are close to a consensus on rapid atropinization.
Topics: Antidotes; Atropine; Dose-Response Relationship, Drug; Humans; Kinetics; Organophosphate Poisoning; Practice Guidelines as Topic
PubMed: 23900961
DOI: 10.1007/s13181-013-0324-9 -
The British Journal of Ophthalmology Aug 2023Informed decisions on myopia management require an understanding of financial impact. We describe methodology for estimating lifetime myopia costs, with comparison... (Review)
Review
BACKGROUND
Informed decisions on myopia management require an understanding of financial impact. We describe methodology for estimating lifetime myopia costs, with comparison across management options, using exemplars in Australia and China.
METHODS
We demonstrate a process for modelling lifetime costs of traditional myopia management (TMM=full, single-vision correction) and active myopia management (AMM) options with clinically meaningful treatment efficacy. Evidence-based, location-specific and ethnicity-specific progression data determined the likelihood of all possible refractive outcomes. Myopia care costs were collected from published sources and key informants. Refractive and ocular health decisions were based on standard clinical protocols that responded to the speed of progression, level of myopia, and associated risks of pathology and vision impairment. We used the progressions, costs, protocols and risks to estimate and compare lifetime cost of myopia under each scenario and tested the effect of 0%, 3% and 5% annual discounting, where discounting adjusts future costs to 2020 value.
RESULTS
Low-dose atropine, antimyopia spectacles, antimyopia multifocal soft contact lenses and orthokeratology met our AMM inclusion criteria. Lifetime cost for TMM with 3% discounting was US$7437 (CI US$4953 to US$10 740) in Australia and US$8006 (CI US$3026 to US$13 707) in China. The lowest lifetime cost options with 3% discounting were antimyopia spectacles (US$7280, CI US$5246 to US$9888) in Australia and low-dose atropine (US$4453, CI US$2136 to US$9115) in China.
CONCLUSIONS
Financial investment in AMM during childhood may be balanced or exceeded across a lifetime by reduced refractive progression, simpler lenses, and reduced risk of pathology and vision loss. Our methodology can be applied to estimate cost in comparable scenarios.
Topics: Humans; Myopia; Atropine; Eye; Refraction, Ocular; Contact Lenses, Hydrophilic; Disease Progression
PubMed: 35264328
DOI: 10.1136/bjophthalmol-2021-320318 -
Asia-Pacific Journal of Ophthalmology...The purpose of this study was to assess the dose-response effects of low-dose atropine on myopia progression and safety in pediatric subjects with mild-to-moderate... (Randomized Controlled Trial)
Randomized Controlled Trial
PURPOSE
The purpose of this study was to assess the dose-response effects of low-dose atropine on myopia progression and safety in pediatric subjects with mild-to-moderate myopia.
METHODS
This phase II, randomized, double-masked, placebo-controlled study compared the efficacy and safety of atropine 0.0025%, 0.005%, and 0.01% with placebo in 99 children, aged 6-11 years, with mild-to-moderate myopia. Subjects received 1 drop in each eye at bedtime. The primary efficacy endpoint was change in spherical equivalent (SE), while secondary endpoints included changes in axial length (AL) and near logMAR (logarithm of the minimum angle of resolution) visual acuity and adverse effects.
RESULTS
The mean±SD changes in SE from baseline to 12 months in the placebo and atropine 0.0025%, 0.005%, and 0.01% groups were -0.55±0.471, -0.55±0.337, -0.33±0.473, and -0.39±0.519 D, respectively. The least squares mean differences (atropine-placebo) in the atropine 0.0025%, 0.005%, and 0.01% groups were 0.11 D ( P =0.246), 0.23 D ( P =0.009), and 0.25 D ( P =0.006), respectively. Compared with placebo, the mean change in AL was significantly greater for atropine 0.005% (-0.09 mm, P =0.012) and 0.01% (-0.10 mm, P =0.003). There were no significant changes in near visual acuity in any of the treatment groups. The most common ocular adverse events were pruritus and blurred vision, each occurring in 4 (5.5%) atropine-treated children. Changes in mean pupil size and amplitude of accommodation were minimal.
CONCLUSIONS
Atropine doses of 0.005% and 0.01% effectively reduced myopia progression in children but no effect was noted with 0.0025%. All doses of atropine were safe and well tolerated.
Topics: Humans; Child; Administration, Topical; Ophthalmic Solutions; Atropine; Myopia; Refraction, Ocular; Axial Length, Eye; Disease Progression
PubMed: 37523428
DOI: 10.1097/APO.0000000000000609 -
The Cochrane Database of Systematic... Oct 2009Amblyopia is defined as defective visual acuity in one or both eyes without demonstrable abnormality of the visual pathway, and is not immediately resolved by wearing... (Meta-Analysis)
Meta-Analysis Review
BACKGROUND
Amblyopia is defined as defective visual acuity in one or both eyes without demonstrable abnormality of the visual pathway, and is not immediately resolved by wearing glasses.
OBJECTIVES
To assess the effectiveness and safety of conventional occlusion versus atropine penalization for amblyopia.
SEARCH STRATEGY
We searched CENTRAL, MEDLINE, EMBASE, LILACS, the WHO International Clinical Trials Registry Platform, preference lists, science citation index and ongoing trials up to June 2009.
SELECTION CRITERIA
We included randomized/quasi-randomized controlled trials comparing conventional occlusion to atropine penalization for amblyopia.
DATA COLLECTION AND ANALYSIS
Two authors independently screened abstracts and full text articles, abstracted data, and assessed the risk of bias.
MAIN RESULTS
Three trials with a total of 525 amblyopic eyes were included. One trial was assessed as having a low risk of bias among these three trials, and one was assessed as having a high risk of bias.Evidence from three trials suggests atropine penalization is as effective as conventional occlusion. One trial found similar improvement in vision at six and 24 months. At six months, visual acuity in the amblyopic eye improved from baseline 3.16 lines in the occlusion and 2.84 lines in the atropine group (mean difference 0.034 logMAR; 95% confidence interval (CI) 0.005 to 0.064 logMAR). At 24 months, additional improvement was seen in both groups; but there continued to be no meaningful difference (mean difference 0.01 logMAR; 95% CI -0.02 to 0.04 logMAR). The second trial reported atropine to be more effective than occlusion. At six months, visual acuity improved 1.8 lines in the patching group and 3.4 lines in the atropine penalization group, and was in favor of atropine (mean difference -0.16 logMAR; 95% CI -0.23 to -0.09 logMAR). Different occlusion modalities were used in these two trials. The third trial had inherent methodological flaws and limited inference could be drawn.No difference in ocular alignment, stereo acuity and sound eye visual acuity between occlusion and atropine penalization was found. Although both treatments were well tolerated, compliance was better in atropine. Atropine penalization costs less than conventional occlusion. The results indicate that atropine penalization is as effective as conventional occlusion.
AUTHORS' CONCLUSIONS
Both conventional occlusion and atropine penalization produce visual acuity improvement in the amblyopic eye. Atropine penalization appears to be as effective as conventional occlusion, although the magnitude of improvement differed among the three trials. Atropine penalization can be used as first line treatment for amblyopia.
Topics: Amblyopia; Atropine; Child; Child, Preschool; Humans; Occlusive Dressings; Ophthalmic Solutions; Randomized Controlled Trials as Topic; Visual Acuity
PubMed: 19821369
DOI: 10.1002/14651858.CD006460.pub2 -
Klinische Monatsblatter Fur... Apr 2023Assessment of diagnostic and therapeutic strategies currently used in routine practice for myopia management in Europe.
PURPOSE
Assessment of diagnostic and therapeutic strategies currently used in routine practice for myopia management in Europe.
METHODS
Online survey study including 11 main questions. The questionnaire was sent to members of the European Paediatric Ophthalmology Society (EPOS). The following items and questions were surveyed: I. Profession and workplace of the survey participants. II. Preventive measures and recommendations for myopia management, a) regarding reading distance and near work, b) optical tools, i.e., application of Defocus Incorporated Multiple Segments (DIMS) glasses, near additions, or contact lenses, and c) the application of atropine eye drops. III. Application of additional diagnostic tools.
RESULTS
Forty-eight individuals completed the survey. Of the respondents, 88% (n = 42) affirmed that they generally gave advice on strategies for myopia prevention and management strategies. Almost all study participants (n = 41; 85%) recommend outdoor time as a preventive measure. The recommendation on near distance is given less frequently, with 28 (58%) participants confirming that they do recommend a "safe" reading distance, and 15 (31%) negating this. Eight (17%) survey participants recommend using near addition glasses, while 36 (75%) do not. Similarly, 35 (73%) respondents do not apply DIMS glasses and 8 (17%) apply them. Fourteen (29%) participants recommend myopia-reducing contact lenses while 30 (63%) do not, and 29 (60%) confirmed that they applied atropine eye drops to slow myopia progression while 14 (29%) do not prescribe these eye drops. The majority of respondents (n = 25; 86%) who prescribe atropine eye drops use atropine 0.01% eye drops.
CONCLUSIONS
Prevention and therapeutic management of childhood myopia is an essential part in the daily routine of pediatric ophthalmologists. Substantial agreement was found for the protective role of outdoor time (85%). The only common therapeutic approach is the administration of atropine eye drops (60%).
Topics: Humans; Child; Ophthalmologists; Disease Progression; Myopia; Atropine; Surveys and Questionnaires; Ophthalmic Solutions; Refraction, Ocular
PubMed: 37164443
DOI: 10.1055/a-2013-2713 -
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