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Introduction: Myopia is a major cause of degenerative eye disease and increases the risk of secondary visual impairment. Mitigating its progression therefore has great potential of clinically relevant benefit as shown by using highly diluted atropine eye drops in children of Asian origin. However, limited evidence is available regarding the efficacy and safety of low-dose atropine therapy in non-Asian populations. Hence, the Low-dose AtropIne for Myopia Control in Children (AIM) study will test the efficacy and safety of 0.02% atropine vs placebo in a German population., Methods and Analysis: AIM is a national, multicentre, prospective, randomised, placebo-controlled, double-blind trial with two parallel arms. The primary objective is to assess the efficacy of atropine 0.02% eyedrops for myopia control in children of Caucasian origin. The primary outcome is the change in cycloplegic refraction after 1 year of treatment (D/year). Secondary and tertiary outcome measures comprise the change in axial length (mm/year) in children treated with 0.02% atropine compared with placebo, the myopic progression of participants treated with 0.01% compared with 0.02% atropine (D/year and mm/year), and the safety profile of both 0.02% and 0.01% atropine. Furthermore, the myopic progression 1 year after cessation of therapy with 0.02% atropine will be evaluated. Inclusion criteria are an age of 8-12 years and myopia of -1 D to -6 D with an estimated annual myopia progression of ≥0.5 D. After randomisation, patients will receive either atropine 0.02% (arm A) or placebo eye drops (arm B) in the first year of treatment. In the second year, they will continue to receive atropine 0.02% (arm A) or switch to atropine 0.01% (arm B). In the third year, they will switch to placebo (arm A) or continue with atropine 0.01% (arm B). To achieve a statistical power of 80%, the calculated sample size is 300. The trial has started in October 2021 with a planned recruitment period of 18 months., Ethics and Dissemination: AIM has been approved by the Central Ethics Committee of the University Medical Center Freiburg (21-1106), local ethics committees of each participating centre and the German Federal Institute for Drugs and Medical Devices (61-3910-4044659). It complies with the Declaration of Helsinki, local laws and ICH-GCP. Results and underlying data from this trial will be disseminated through peer-reviewed publications and conference presentations., Trial Registration Number: NCT03865160., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2023. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

Purpose: Daily administration of 0.01% atropine eye drops is a promising approach for myopia control. The mechanism of action is believed to involve the dopaminergic system of the retina, triggering an increased release of dopamine. Previous studies in psychiatric condition such as major depression suggest that pattern electroretinogram (PERG) amplitudes are modulated by changes in retinal dopamine. It is thus plausible that atropine eye drops could have an effect on PERG amplitudes. The present study was designed to test this, assessing the difference in amplitude between contrast levels and the ratio of amplitudes between check sizes as primary endpoints., Methods: We included 14 participants with no more than ± 2 diopters of ametropia and visual acuity of at least 1.0. One eye was chosen randomly in each participant for atropine application (14 days, one drop of 0.01% atropine solution once daily before bedtime). We recorded two sets of steady-state PERG recordings: one with different contrasts (25% and 98%) and one with different check sizes (0.8° and 17°). Near-point distance, near visual acuity, and pupil diameter were measured additionally., Results: The recordings to different contrasts did not show atropine-related changes of PERG amplitude. A small increase by 6% of the amplitude difference between contrast levels with atropine application was not significant (p = 0.08). Raw amplitudes in the check size condition increased with atropine by 17% (p < 0.01) and 10% (p < 0.03) for small and large checks, respectively, without a significant concomitant effect on the amplitude ratio. Pupil size was significantly affected (median increase 0.5 mm, p < 0.002). However, neither of the experimental conditions was associated with a significant correlation between pupil size and PERG effects., Conclusion: The effects on PERG primary endpoints after the 14-day period of atropine administration were small, especially compared to effect sizes in major depression, and statistically insignificant. Effects on raw amplitude were inconsistent. The present results suggest that retinal processing as reflected by PERG does not sizably change following a treatment regimen with atropine that is typical for myopia control.

Myopia is on the increase worldwide and will become a major challenge over the next decades in terms of secondary ophthalmologic complications. There are effective therapeutic options available to slow or prevent the progression of myopia. So far, it has not been investigated whether there are possible additive effects of these interventions. Further investigations - especially in Caucasian populations - are necessary to verify the study results available from Asia. There is limited data on how long further progression of myopia is preventable. A therapy appears reasonable as long as a progression of myopia is detectable.Consistent childhood amblyopia screening provides a cost-effective measure for the prevention of visual disturbances over the course of life. How this can be best integrated into the existing system of "U-investigations", must be clarified by the cost-bearers and professional associations. This discourse should be supported by close interdisciplinary exchange and further studies on the prevalence of different degrees of amblyopia. In addition, sensitive and specific or even multi-stage tests should be developed in order to implement an early detection that is cost-effective and saves resources., Competing Interests: Die Autoren geben an, dass kein Interessenkonflikt besteht., (Georg Thieme Verlag KG Stuttgart · New York.)

Background: Nearsightedness (myopia) has become more common around the world recently, mainly because of changes in visual, educational, and recreational behavior. The question arises how the risk of myopia and its progression can be reduced. This would lessen the prevalence and severity of myopia and also lower the risk of secondary diseases that impair visual acuity., Methods: The PubMed/Medline database was selectively searched for pertinent literature., Results: The risk of myopia is lowered by exposure to daylight and increased by activities performed at short visual distances (close-up work). A person with little exposure to daylight has a fivefold risk of developing myopia, which can rise as high as a 16-fold risk if that person also performs close-up work. Two meta-analyses and a large randomized clinical trial from Asia have shown that the progression of myopia over two years of observation can be lessened by up to 0.71 diopters by the administration of atropine eye drops in a concentration that has practically no serious side effects. At higher doses, myopia progresses more severely than in the placebo group after the cessation of therapy. This is an off-label treatment. A weaker effect on progression has been shown for multifocal optical corrections that include both a distance correction and a correction for near vision., Conclusion: Effective pharmacological and optical measures are now available to lessen the progression of myopia. The increasing prevalence of myopia should motivate pediatricians, parents, and schools to pay attention to risk factors such as close-up work and lack of daylight exposure, particularly in view of the increased use of digital media.

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Purpose: There is a strong association between severe hyperhomocysteinemia and myopia. Thus we studied the hypothesis that even moderately increased levels of homocysteine (Hcy) might be a potentially treatable risk factor for myopia. Methods: The Gutenberg Health Study (GHS) is a population-based, prospective, observational cohort study in Germany, including 15,010 participants aged between 35 and 74 at recruitment. The baseline examination was conducted from 2007–2012. Refraction was measured using autorefraction (HARK 599, Carl Zeiss AG, Jena, Germany). Hcy was measured by an immunoassay. We included only phakic participants without a history of corneal surgery or corneal laser treatment. We used linear regression models to evaluate the potential association between Hcy and refraction at baseline, and between Hcy and change in refraction between baseline and 5-year-follow-up examination. We used generalized estimating equation models to account for the correlation between fellow eyes. Results: We included 13,749 participants, categorized as having no myopia (spherical equivalent > -0.75 D, 65.2%), low myopia (-0.75 D–-2.75 D, 21.5%), moderate myopia (-3.00 D– 5.75 D, 9.8%) and high myopia (≤ -6 D, 3.5%). Median Hcy levels were similar in all groups (μmol/l). We observed no association of Hcy with refraction or 5-year change in refraction in the models adjusted for age, sex and socioeconomic status. Conclusion: We found no evidence for an association of Hcy levels and refractive error. [ABSTRACT FROM AUTHOR]