{"id":13757,"date":"2019-02-06T17:09:26","date_gmt":"2019-02-06T17:09:26","guid":{"rendered":"https:\/\/www.elza-institute.com\/?p=13757"},"modified":"2020-10-02T15:41:49","modified_gmt":"2020-10-02T15:41:49","slug":"cxl-in-the-usa-part-3-off-label-applications","status":"publish","type":"post","link":"https:\/\/www.elza-institute.com\/pt\/cxl-in-the-usa-part-3-off-label-applications\/","title":{"rendered":"Cross-Linking nos EUA - Parte 3: Aplica\u00e7\u00f5es n\u00e3o autorizadas"},"content":{"rendered":"

Cross-Linking: Aplica\u00e7\u00f5es n\u00e3o autorizadas <\/strong><\/h3>\n

Epi-off CXL<\/strong><\/p>\n

\"Cross-Linking:
Deixar o epit\u00e9lio na c\u00f3rnea (representado pela cebola \u00e0 direita) torna muito mais dif\u00edcil a penetra\u00e7\u00e3o da riboflavina no estroma da c\u00f3rnea (cebola; esquerda).<\/em><\/figcaption><\/figure>\n

O reticulado da c\u00f3rnea n\u00e3o \u00e9 isento de inconvenientes. Gra\u00e7as \u00e0 necessidade de remover os 9 mm centrais de c\u00e9lulas epiteliais da c\u00f3rnea antes da instila\u00e7\u00e3o de riboflavina, o protocolo padr\u00e3o de Dresden, epi-off, est\u00e1 associado a uma dor p\u00f3s-operat\u00f3ria n\u00e3o trivial, a uma recupera\u00e7\u00e3o visual lenta, bem como a pequenos riscos de infe\u00e7\u00e3o, cicatrizes na c\u00f3rnea e mesmo perfura\u00e7\u00e3o. O Epi-on CXL (que \u00e9 completamente off-label) tem como objetivo contornar estes problemas, deixando o epit\u00e9lio intacto. Isto tem o pre\u00e7o de uma efic\u00e1cia reduzida - nenhum ensaio cl\u00ednico publicado at\u00e9 \u00e0 data demonstrou de forma convincente que o epi-on CXL \u00e9 t\u00e3o eficaz como o epi-off CXL no resultado mais importante: impedir a progress\u00e3o do ceratocone (1). Os autores do relat\u00f3rio da Cornea Society (2) reconhecem que, quando a efic\u00e1cia do epi-on CXL se aproximar da efic\u00e1cia do atual gold standard, o epi-off CXL, a rela\u00e7\u00e3o risco-benef\u00edcio mudar\u00e1 para o epi-on CXL e, com um diagn\u00f3stico mais precoce, um tratamento mais precoce, \"sem necessidade de demonstrar a progress\u00e3o, poder\u00e1 tornar-se padr\u00e3o\". No entanto, esse momento ainda n\u00e3o chegou.<\/p>\n

Ir mais depressa<\/strong><\/p>\n

\"Cross-Linking:
A tartaruga e a lebre - o aumento da intensidade de UV pode diminuir o tempo necess\u00e1rio para reticular uma c\u00f3rnea, mas a efic\u00e1cia diminui a partir de um determinado limiar.<\/em><\/figcaption><\/figure>\n

A rea\u00e7\u00e3o fotoqu\u00edmica que ocorre no CXL para gerar esp\u00e9cies reactivas de oxig\u00e9nio foi durante muito tempo descrita pela lei da reciprocidade de Bunsen-Roscoe, que afirma \"o efeito bioqu\u00edmico fotoqu\u00edmico da luz ultravioleta \u00e9 proporcional \u00e0 dose total de energia fornecida, independentemente da irradi\u00e2ncia e do tempo aplicados\", e utilizada como justifica\u00e7\u00e3o para a utiliza\u00e7\u00e3o de defini\u00e7\u00f5es de irradi\u00e2ncia UV de alta pot\u00eancia para reduzir drasticamente o tempo de irradia\u00e7\u00e3o. No entanto, isto ignora a contribui\u00e7\u00e3o essencial do oxig\u00e9nio para a rea\u00e7\u00e3o de reticula\u00e7\u00e3o e o tempo necess\u00e1rio para o oxig\u00e9nio se difundir e repor o oxig\u00e9nio consumido na rea\u00e7\u00e3o. Por outras palavras, \u00e0 medida que a intensidade da irradia\u00e7\u00e3o UV aumenta para al\u00e9m da capacidade de o oxig\u00e9nio se difundir no estroma e repor o que se esgota na rea\u00e7\u00e3o fotoqu\u00edmica UV-riboflavina, menor ser\u00e1 o seu efeito de reticula\u00e7\u00e3o por unidade de tempo.<\/p>\n

Os autores analisaram uma s\u00e9rie de ensaios que utilizaram uma intensidade de irradia\u00e7\u00e3o mais elevada, mas tempos de irradia\u00e7\u00e3o mais curtos do que os 5,4 mw\/cm do protocolo de Dresden2<\/sup> durante 30 minutos, nomeadamente 7 mw\/cm2<\/sup> durante 15 minutos, 9 mw\/cm2<\/sup> durante 10 minutos, 18 mw\/cm2<\/sup> durante 5 minutos, e 30 mw\/cm2<\/sup> durante 3 minutos. Todos os protocolos, com exce\u00e7\u00e3o de um, apresentaram resultados semelhantes em termos de efic\u00e1cia ao protocolo de Dresden - 30 mw\/cm2<\/sup> A irradia\u00e7\u00e3o durante 3 minutos foi considerada menos eficaz. No entanto, os autores do relat\u00f3rio referem que \"s\u00e3o necess\u00e1rios mais estudos a longo prazo para validar a efic\u00e1cia a longo prazo do CXL acelerado\".<\/p>\n

Adicionar PRK e an\u00e9is<\/strong><\/p>\n

\"Cross-Linking:
Um doente pode ter a mesma acuidade visual em ambas as imagens, mas a qualidade da imagem da direita (ap\u00f3s CXL, PRK e coloca\u00e7\u00e3o de lentes esclerais) \u00e9 superior \u00e0 da imagem da esquerda (apenas ap\u00f3s CXL).<\/figcaption><\/figure>\n

As c\u00f3rneas queratoc\u00f3nicas s\u00e3o distorcidas e, \u00e0 medida que a doen\u00e7a progride e o cone cresce, tanto a acuidade visual como a qualidade visual s\u00e3o afectadas negativamente. O CXL altera a forma do cone e da c\u00f3rnea irradiada que o rodeia, mas isto n\u00e3o resulta necessariamente numa melhoria da acuidade ou da qualidade visual - frequentemente, uma ou ambas pioram (normalmente de forma tempor\u00e1ria) ap\u00f3s o CXL. No entanto, em alguns casos, \u00e9 poss\u00edvel combinar o CXL com a queratectomia fotorrefractiva guiada por topografia (PRK; por vezes designada por CXL Plus) para proporcionar uma melhor qualidade e acuidade visual aos doentes - por vezes em combina\u00e7\u00e3o com lentes r\u00edgidas. A adi\u00e7\u00e3o de \"an\u00e9is\" - segmentos de anel corneano intracorneano - para al\u00e9m do CXL - pode levar a um maior achatamento do cone e, nalguns casos, a melhores resultados visuais.<\/p>\n

Adicionar o CXL ao LASIK<\/strong><\/p>\n

\"Cross-Linking:
Combina\u00e7\u00e3o de LASIK com CXL - repare na aba de LASIK na parte inferior da imagem.<\/figcaption><\/figure>\n

A cria\u00e7\u00e3o de um retalho LASIK enfraquece a c\u00f3rnea e, embora seja raro, a ectasia p\u00f3s-LASIK (que se apresenta como um caso agressivo de ceratocone) pode ser evitada atrav\u00e9s da reticula\u00e7\u00e3o das c\u00f3rneas imediatamente ap\u00f3s um procedimento LASIK. Os procedimentos em que uma maior quantidade de estroma \u00e9 ablacionada com o excimer laser (como na corre\u00e7\u00e3o da alta miopia, na corre\u00e7\u00e3o da hipermetropia, em c\u00f3rneas finas\/c\u00f3rneas com uma menor espessura residual do leito ap\u00f3s o LASIK) podem, em teoria, beneficiar do CXL, embora com perfis de energia de irradia\u00e7\u00e3o UV mais baixos e tempos de ilumina\u00e7\u00e3o mais curtos (uma vez que se trata de olhos \"normais\").<\/p>\n

Por um lado, existem agora dados sobre LASIK e cross-linking a 2 anos sem relatos de ectasia, mas, por outro lado, a maioria dos casos demora cerca de 5-10 anos a desenvolver-se ap\u00f3s a opera\u00e7\u00e3o (e a maioria das pessoas tratadas com LASIK tem c\u00f3rneas normais, em vez de c\u00f3rneas com um risco acrescido de ectasia), o que significa que a Cornea Society considera que \"Atualmente, n\u00e3o existem dados suficientes para apoiar um benef\u00edcio da combina\u00e7\u00e3o de LASIK com CXL em olhos com um risco real de ectasia p\u00f3s-LASIK\".<\/p>\n

Parte 4: O futuro<\/a><\/p>","protected":false},"excerpt":{"rendered":"

O Epi-on CXL tem como objetivo contornar os problemas do epi-off CXL, deixando o epit\u00e9lio intacto, mas isto tem o pre\u00e7o de uma efic\u00e1cia reduzida - nenhum ensaio cl\u00ednico publicado at\u00e9 \u00e0 data demonstrou de forma convincente que o epi-on CXL \u00e9 t\u00e3o eficaz como o epi-off CXL no resultado mais importante: impedir a progress\u00e3o do ceratocone.<\/p>","protected":false},"author":4,"featured_media":16083,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[214,97],"tags":[148,287,288,100,289,104,290,291,292,293],"class_list":["post-13757","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-farhad-hafezi","category-podium-power","tag-accelerated-cxl","tag-avedro","tag-customized-cxl","tag-cxl","tag-infection","tag-pack-cxl","tag-photrexa","tag-photrexa-viscous","tag-riboflavin","tag-usa"],"acf":[],"yoast_head":"\nCross-Linking in the USA \u2013 Part 3: Off-Label applications<\/title>\n<meta name=\"description\" content=\"The FDA approved CXL to treat keratoconus and post-LASIK ectasia following the standard epi-off Dresden Protocol - 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