Five-year results of atropine 0.01% efficacy in the myopia control in a European population

Abstract

AimsTo evaluate the efficacy and safety of 0.01% atropine eye-drops in controlling myopia progression over 5 years.MethodsExperimental, analytical, prospective, randomised and longitudinal study, in 361 right eyes from 361 children randomised into the control group (177 eyes without treatment) and treatment group (184 eyes with 0.01% atropine eye-drops). Children assigned to the treatment group used 0.01% atropine once a day every night and the control group’s children did not use any treatment or placebo. All the subjects completed an eye examination every 6 months for the 5 years of follow-up. The examination included subjective and objective refraction with cycloplegia, axial length (AL), keratometry and anterior chamber depth (ACD) to evaluate the efficacy of the treatment. It also included the anterior and posterior pole examination to evaluate the safety of the treatment.ResultsThe SE increased −0.63±0.42D in children after 5 years of treatment with 0.01% atropine, while in the control group the increase was −0.92±0.56D. AL increased 0.26±0.28 mm in the treatment group compared with 0.49±0.34 mm in the control group. Atropine 0.01% showed an efficacy of 31.5% and 46.9% in the control of the SE and AL increase, respectively. ACD and keratometry did not have significant changes between groups.ConclusionsAtropine 0.01% is effective in slowing myopia progression in a European population. There were no side effects after 5 years of 0.01% atropine.

Age-related results over 2 years of the multicenter Spanish study of atropine 0.01% in childhood myopia progression

“…On the other hand, a lower rate of progression over 2 years has been observed among the untreated participants of a Spanish series, with a mean SE progression of − 0.76 D and an AL increase of 0.37 mm, versus − 0.51 D and 0.20 mm, respectively, in the atropine 0.01% treated group 26 . Interestingly, in another recent publication with Spanish children, the 5-year progression in the no-treatment group was − 0.92 ± 0.56 D, with an AL increase of 0.49 ± 0.34 mm 27 . These findings highlight the necessity to compare studies not only with similar age and ethnicity but also with similar baseline characteristics: the proportion of mild myopic patients in these two series seem to be higher than ours: a mean SE of − 2.14 D (range − 0.50 to − 4.50 D) is far from our − 3.57 D (range from − 2 to – 6 D).…”

Trumparegystės Progresavimo Kontrolė Mažos Koncentracijos Atropino Akių Lašais

“…Nors mažos dozės atropinas yra plačiai naudojamas visame pasaulyje, su Europos populiacija atliktų tyrimų yra tik keli. M. Moriche-Carretero ir Perez-Flores patvirtino 0,01% atropino efektyvumą stabdant trumparegystės progresavimą ispanų populiacijoje [24][25][26]. Danijos populiacijoje 0,01% atropino lašų efektyvumas nepatvirtintas [27].…”

“…Nustatytas vidutinis SE ir ašies ilgio pokytis siekė − 0,44 ± 0,41 D ir 0,27 ± 0,20 mm. Vidutinis SE pokytis vienerių metų laikotarpyje nustatytas mažesnis pradėjus lašinti atropiną (prieš gydymą − 1,01 ± 0,38 D, su atropino lašais 0,01% − 0,44 ± 0,41 D) [25,26]. Danijoje atlikto tyrimo metu vertintas 0,01% atropino lašų efektyvumas.…”

Myopia Control: Are We Ready for an Evidence Based Approach?

“…Similarly, in another recently published systematic review the estimated mean difference (MD) for myopia progression for atropine was found to be 0.29 D (95% CI 0.22-0.36; p = 0.03) [58]. In the present review, the most recent 16 out of initial 41 articles on RCTs were analyzed (Supplementary Table 3): a noticeable difference between these studies can be observed in terms of sample size [107][108][109], study length and design [110][111][112][113][114], the age of the children studied [106,109], location of trial [115][116][117], and the different atropine doses, which varied between 0.0025% and 1%, as well as the application frequency of drops [110,114,118,119], and lastly their aims [109,111,112,120]. Almost half of the selected studies were conducted in East Asia, in predominately Chinese ethnic children [109,110,114,115,[118][119][120].…”

“…Almost half of the selected studies were conducted in East Asia, in predominately Chinese ethnic children [109,110,114,115,[118][119][120]. Four studies were conducted in Europe [107,111,112,116], two in India [113,117], one in Iran [108], one in the USA [121], and one in Australia [106]. Upon comparing these studies, it may be inferred that varying ethnic groups exhibit dosedependent differences in the pharmacokinetics and the effect of atropine.…”