Author's reply

Díaz Llopis, M.

doi:10.1016/j.oftale.2018.11.011

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A 5-year study of safety and effectiveness" "tienePdf" => "en" "tieneTextoCompleto" => "en" "paginas" => array:1 [ 0 => array:2 [ "paginaInicial" => "153" "paginaFinal" => "154" ] ] "titulosAlternativos" => array:1 [ "es" => array:1 [ "titulo" => "Comentarios al artículo: La atropina superdiluida al 0,01% frena el aumento de la miopía en niños españoles. Un estudio a largo plazo 5 años de evolución: seguridad y eficacia" ] ] "contieneTextoCompleto" => array:1 [ "en" => true ] "contienePdf" => array:1 [ "en" => true ] "autores" => array:1 [ 0 => array:2 [ "autoresLista" => "J. Barrio-Barrio, I. Pérez-Flores" "autores" => array:2 [ 0 => array:2 [ "nombre" => "J." "apellidos" => "Barrio-Barrio" ] 1 => array:2 [ "nombre" => "I." "apellidos" => "Pérez-Flores" ] ] ] ] ] "idiomaDefecto" => "en" "Traduccion" => array:1 [ "es" => array:9 [ "pii" => "S0365669118303289" "doi" => "10.1016/j.oftal.2018.10.008" "estado" => "S300" "subdocumento" => "" "abierto" => array:3 [ "ES" => false "ES2" => false "LATM" => false ] "gratuito" => false "lecturas" => array:1 [ "total" => 0 ] "idiomaDefecto" => "es" "EPUB" => "https://multimedia.elsevier.es/PublicationsMultimediaV1/item/epub/S0365669118303289?idApp=UINPBA00004N" ] ] "EPUB" => "https://multimedia.elsevier.es/PublicationsMultimediaV1/item/epub/S2173579418301816?idApp=UINPBA00004N" "url" => "/21735794/0000009400000003/v1_201903010631/S2173579418301816/v1_201903010631/en/main.assets" ] "en" => array:13 [ "idiomaDefecto" => true "cabecera" => "Letter to the Editor" "titulo" => "Author's reply" "tieneTextoCompleto" => true "saludo" => "Dear Editor:" "paginas" => array:1 [ 0 => array:2 [ "paginaInicial" => "154" "paginaFinal" => "156" ] ] "autores" => array:1 [ 0 => array:3 [ "autoresLista" => "M. Díaz Llopis" "autores" => array:1 [ 0 => array:3 [ "nombre" => "M." "apellidos" => "Díaz Llopis" "email" => array:1 [ 0 => "manuel.diaz@uv.es" ] ] ] "afiliaciones" => array:1 [ 0 => array:2 [ "entidad" => "Hospital La Fe, Universidad de Valencia, Valencia, Spain" "identificador" => "aff0005" ] ] ] ] "titulosAlternativos" => array:1 [ "es" => array:1 [ "titulo" => "Respuesta de los autores" ] ] "textoCompleto" => "Considering the significant international impact of our article on the efficacy of super diluted atropine to slow down the progression of myopia, we encourage the co-authors of the Letter to the Editor to participate in the ongoing national and international multicenter study which we are coordinating under the sponsorship of the Myopia Society of Spain in order to clarify relevant supplementary aspects which were not covered in said study (nonresponders, different dosages, etc.). We are very grateful for your constructive comments and wish to state that we are entirely in agreement with the following points:<ul class="elsevierStyleList" id="lis0005"><li class="elsevierStyleListItem" id="lsti0005">1.It is, in fact, the longest term study carried out with treatment, due to the fact that a detailed analysis of the rest of studies share the same patient follow-up periods but significantly shorter treatment periods (3 versus 5 years).</li><li class="elsevierStyleListItem" id="lsti0010">2.We agree in that “the evidence of the efficacy of atropine in myopic progression was a casual and unexpected finding”, and that the “pioneers published this finding for the first time in 2012” can only be sustained by profound ignorance and an extremely superficial analysis of scientific literature because the demonstrated efficacy of atropine on the progression of myopia has been published since 1874, and confirmed in the modern age since 1971, with the ratification of its efficacy at very low doses in a range of scientific articles published between 1999 and 2006 and which constituted the basis for our study. Numerous and prestigious experimental studies published in the past 30 years about the way in which atropine slows down myopia due to its capacity to increase intraocular dopamine production and act on the M receptors of the sclera fibroblast cannot be ignored or dismissed by defining the finding as “casual”, because they were the result of sound and consolidated decades-long research lines.<a class="elsevierStyleCrossRefs" href="#bib0040">1–5</a></li><li class="elsevierStyleListItem" id="lsti0015">3.We believe that the comments of the co-authors of the letter to the editor about our masterful research finding is excessively generous, enthusiastic and undeserved because it is based on many hours of research on Pubmed covering many decades of hard and honest work striving to find solutions for this important problem that affects 2.5 billion inhabitants (misprint of said letter, that mentioned 2500 billion).</li><li class="elsevierStyleListItem" id="lsti0020">4.We also agree entirely in that, despite large financial and marketing interests, there is no optical treatment that has demonstrated efficiency in halting myopia even though the authors of said letter did not delve deep enough to reach this conclusion. The analysis of studies on Ortho-K or pajama contact lenses are methodologically tainted by taking efficacy data on axial length and refraction just a few hours after their withdrawal, preempting the lag effect of said lenses, the only demonstrated effect of which is a temporary deformation of the cornea. Moreover, the articles on this product admit that any effect would be applicable only to high myopia—not at an early stage for prevention and only in the short-term—reaching the same progression level as the control group after the third year, making any benefit temporary and reversible as soon as their use is interrupted. In what concerns bifocal/multifocal dual focus lenses, on the basis of the theory that correcting the out-of-focus of the peripheral retina which, by virtue of mysterious and never documented stimuli, would halt myopia, they forget that: (1) the only published study is not independent but funded by a multinational company to promote the use of their MySight® lens, which is legitimate at the marketing level but not scientifically, and (2) the researcher who proposed the peripheral retinal out-of-focus theory, the optometry professor Mr. Atchinson, has since denied and unauthorized said theory.<a class="elsevierStyleCrossRef" href="#bib0065">6</a> We therefore reaffirm our statement that there is no scientifically documented optical treatment that can slow down myopia, although marketing is a different matter. Optical aids to slow down myopia only benefit the professional who prescribes and sells them.</li><li class="elsevierStyleListItem" id="lsti0025">5.The study was randomized and prospective. Confirmed! Just a little clinic experience allows anyone to understand that the treatment group that completed the 5 years of the study exhibited a high percentage of leavers, which means that it can only be maintained in children or teenagers driven by parent motivation. It is absurd to imply that the untreated control group did not have motivated parents.</li><li class="elsevierStyleListItem" id="lsti0030">6.The study was carried out in Spain and all study patients were healthy, obviously Caucasian and free of strabismus, amblyopia or other associated ophthalmological disease. It would have been a gross methodological mistake to design the study differently. We must not forget that, in contrast with hypermetropic children, myopic children rarely have amblyopia or strabismus. The eyedrops were prepared always with the same protocol, i.e., diluting the 1% off the shelf atropine eyedrops (BSS®, Alcon Cusí, Barcelona, Spain), which in addition facilitated general and very affordable preparations accessible to any ophthalmologist. The method for evaluating side effects was simple and practical, staying away from suggested theoretical designs that are not applied in other studies of this type—questionnaires, tests, scales, etc.—, and highly immersed in daily clinic practice, asking parents about tolerance during checkup visits and establishing a contact phone number for events. As easy as that. Cyclopegia was done with tropicamide for 2 very important and practical reasons: (1) myopics have an obvious accommodative weakness, and previous studies carried out by our group have confirmed the absence of refractive differences with cyclopentolate in this population segment. The contrary occurs with hypermetropics, who do exhibit said differences, and (2) A short, 4-h cyclopegia enables the child to go back to school the following day, which is not the case with considerably longer cyclopentolate which fostered poor school attendance without contributing any benefit. Axial length is an easier measure to implement in studies starting in 2018, but this was not the case in 2006, when the present study began recruiting subjects. On the basis of our broad clinic experience, we can say that overvaluing said measure is dangerous (because it is very difficult to reliably measure axial length in children between 8 and 14 years of age) and could give rise to many false positives or negatives that invalidate the laborious measurements, taking into account that every millimeter of ocular growth is able to influence in −3 diopters. It is a supplementary but never a core data of studies. In addition, studies such as that reporting the false efficacy of the Ortho-K contact lenses simply cover up its lack of efficacy. The relationship between myopia and iris color that was suggested to be included in the study has no scientific basis and it is documented only in books of the erroneously called alternative holistic iridology medicine.</li><li class="elsevierStyleListItem" id="lsti0035">7.The only point in which we do not agree with the co-authors of said letter is the statement that other studies carried out with mean refraction values of −4.5 diopters, baseline myopia values above −2 diopters and progressions exceeding half a diopter per year are significantly “less relevant” than ours. We believe that those studies simply began later and had different objectives, i.e., analyzing the prevention of myopia from early stages, and focusing on the analysis of refractory or non-responder patients. They are not less relevant but highly supplementary. In addition, the co-authors of said letter confuse baseline mean refraction with sample selection criteria (?) when both are totally unrelated. Despite the methodological variations with the rest of similar studies, the efficacy of the present study objectively produced similar numbers in efficacy and confirms the use of diluted atropine eyedrops as the most validated and efficient alternative to slow down the progression of myopia, as officially recognized last year by the American Academy of Ophthalmology.<a class="elsevierStyleCrossRef" href="#bib0070">7</a></li></ul>" "pdfFichero" => "main.pdf" "tienePdf" => true "NotaPie" => array:1 [ 0 => array:2 [ "etiqueta" => "☆" "nota" => "Please cite this article as: Díaz Llopis M. La atropina superdiluida al 0,01% frena el aumento de miopía en niños-adolescentes. Un estudio a largo plazo 5 años de evolución: seguridad y eficacia. Arch Soc Esp Oftalmol. 2019;94:155–156." ] ] "bibliografia" => array:2 [ "titulo" => "References" "seccion" => array:1 [ 0 => array:2 [ "identificador" => "bibs0015" "bibliografiaReferencia" => array:7 [ 0 => array:3 [ "identificador" => "bib0040" "etiqueta" => "1" "referencia" => array:1 [ 0 => array:2 [ "contribucion" => array:1 [ 0 => array:2 [ "titulo" => "On the atropine treatment of acquired and progressive myopia" "autores" => array:1 [ 0 => array:2 [ "etal" => false "autores" => array:1 [ 0 => "H. 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Archivos de la Sociedad Española de Oftalmología is the official journal of the Ophthalmology Society of Spain, that has over 4,000 members. It gives priority to the publication of basic, translational and clinic research including reviews, original articles, short communications, editorials, letters to the editor and clinic practice guides related to Ophthalmology and its subspecialties. A small section of the journal is reserved for the most relevant papers presented at the annual Congress of the Society. All manuscripts considered for publication are reviewed by expert examiner peers (double blind). The journal is published monthly and even though its official language is Spanish all articles are translated into English to increase the dissemination of scientific information. At present, Archivos is the only Spanish language Ophthalmology journal indexed in PubMed/MEDLINE in addition to other prestigious international databases such as Scopus.

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Vol. 94. Issue 3.

Pages 154-156 (March 2019)

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