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Advisor(s)
Abstract(s)
Sabe-se que existe um procedimento específico, com recursos humanos especializados
e certificados, para se realizar um estudo refrativo no âmbito de ensaios clínicos. No
entanto, na consulta de Oftalmologia de rotina o procedimento não é o mesmo. Neste
sentido, o principal objetivo deste estudo foi comparar o outcome visual após refração
de screening em ensaios clínicos (REC) com refração subjetiva (RS) de rotina na
consulta (RSR).
Tratou-se de um estudo retrospetivo em 34 indivíduos (grupo controlo: n=24 olhos;
grupo de doentes: n=44 olhos) com RSR e refração subjetiva em visita de screening
para ensaios clínicos (EC), com intervalo entre refrações menor que 30 dias. Foram
avaliadas as diferenças encontradas entre os parâmetros refrativos das 2 visitas e a
melhor acuidade visual corrigida (MAVC) com a escala de Snellen na consulta de rotina
e com escalas Early Treatment Retinopathy Study (ETDRS) na visita de screening para
EC, para os dois grupos de estudo.
Dos 68 olhos estudados dos 34 participantes neste estudo, a acuidade visual (AV)
média após RSR foi de 65,8±19,7 letras passando para 72,1±17,9 letras após REC,
registando um ganho médio de 6,3 letras (p<0,001). A melhoria também foi verificada
separando os participantes em grupo de controlo (4,3 letras; p<0,001) e grupo com
várias patologias oftalmológicas, sendo esta diferença mais evidente neste último (7,5
letras; p<0,001). Foi também no grupo com patologia que se verificaram as maiores
diferenças quanto aos parâmetros refrativos avaliados na RSR e REC.
Deste modo pode-se concluir que a REC permite atingir um melhor outcome visual.
Apesar do tempo de treino e execução da técnica na REC ser maior do que numa RSR,
é importante fazer refrações tão detalhadas quanto possível em pacientes com
patologias porque são o grupo de pacientes que mais poderão beneficiar com esse
investimento de tempo.
It is known that there is a specific procedure, with specialized and certificate human resources, to perform a refractive study in clinical trials. However, in routine ophthalmological consultation the procedure is not the same. In this sense, the main goal of this study was to compare the visual outcome after screening clinical trials refraction (CTR) with routine subjective refraction at the consultation (RsR). It was a retrospective study including 34 subjects (control group: n = 24 eyes; patient group: n = 44 eyes) with RsR and subjective refraction at a screening visit for clinical trials, with a refractive interval shorter than 30 days. The differences found between the refractive parameters of the 2 visits and the best corrected visual acuity with the Snellen scale in the routine appointment and the Early Treatment Retinopathy Study scales at the screening visit to clinical trials were evaluated for the two groups. 68 eyes studied from the 34 participants in this study present a mean visual acuity after RsR of 65,8 ± 19,7 letters goes to 72,1 ± 17,9 letters after CTR, with an average gain of 6,3 letters (p<0,001). The improvement was also verified by separating the participants in the control group (4,3 letters, p<0,001) and a group with several ophthalmologic pathologies, being difference more evident in the latter (7,5 letters, p<0,001). It was also in the group with pathology that the greatest differences were verified regarding the refractive parameters evaluated in RsR and CTR. In this way, it can be concluded that the CTR allows a better visual outcome. Although the training and execution time is greater in CTR than in RsR, it is important to make as detailed refractions as possible in patients with pathologies because they are the group who will most benefit from this investment of time.
It is known that there is a specific procedure, with specialized and certificate human resources, to perform a refractive study in clinical trials. However, in routine ophthalmological consultation the procedure is not the same. In this sense, the main goal of this study was to compare the visual outcome after screening clinical trials refraction (CTR) with routine subjective refraction at the consultation (RsR). It was a retrospective study including 34 subjects (control group: n = 24 eyes; patient group: n = 44 eyes) with RsR and subjective refraction at a screening visit for clinical trials, with a refractive interval shorter than 30 days. The differences found between the refractive parameters of the 2 visits and the best corrected visual acuity with the Snellen scale in the routine appointment and the Early Treatment Retinopathy Study scales at the screening visit to clinical trials were evaluated for the two groups. 68 eyes studied from the 34 participants in this study present a mean visual acuity after RsR of 65,8 ± 19,7 letters goes to 72,1 ± 17,9 letters after CTR, with an average gain of 6,3 letters (p<0,001). The improvement was also verified by separating the participants in the control group (4,3 letters, p<0,001) and a group with several ophthalmologic pathologies, being difference more evident in the latter (7,5 letters, p<0,001). It was also in the group with pathology that the greatest differences were verified regarding the refractive parameters evaluated in RsR and CTR. In this way, it can be concluded that the CTR allows a better visual outcome. Although the training and execution time is greater in CTR than in RsR, it is important to make as detailed refractions as possible in patients with pathologies because they are the group who will most benefit from this investment of time.
Description
Trabalho realizado para a obtenção do Título de Especialista na área de Tecnologias de Diagnóstico e Terapêutica – Ortóptica
Keywords
Outcome visual Refração de screening em ensaios clínicos (REC) Refração subjetiva (RS Rotina na consulta (RSR)