ABSTRACT
INTRODUCTION: Patients with diabetic macular edema can develop fundus autofluorescence alterations; thus far, these alterations have been more widely studied with scanning or confocal laser systems. OBJECTIVE: To describe and classify fundus autofluorescence abnormal patterns in patients with diabetic macular edema using the fundus autofluorescence system with a flash camera. METHOD: Observational, retrospective, cross-sectional, descriptive study. Fundus autofluorescence digital images of non-comparative cases with untreated diabetic macular edema, obtained and stored with a flash camera system, were assessed. Inter-observer variability was evaluated. RESULTS: 37 eyes of 20 patients were included. Lens opacity was the most common cause of inadequate image quality. Five different fundus autofluorescence patterns were observed: decreased (13%), normal (40%), focal hyper-autofluorescent (17%), multi-focal hyper-autofluorescent (22%) and plaque-like hyper-autofluorescent (8%). The kappa coefficient was 0.906 (p = 0.000). CONCLUSIONS: Different fundus autofluorescence phenotypic patterns are observed with flash camera systems in patients with diabetic macular edema. A more accurate phenotypic classification could help establish prognostic factors for visual loss or for the design of clinical trials for diabetic macular edema.
INTRODUCCIÓN: Los pacientes con edema macular diabético pueden presentar alteraciones en la autofluorescencia retiniana, que hasta el momento han sido analizadas más con sistemas de láser de barrido o confocales. OBJETIVO: Describir y clasificar los patrones anormales de autofluorescencia retiniana en pacientes con edema macular diabético mediante el sistema de autofluorescencia retiniana con cámara de flash. MÉTODO: Estudio observacional, retrospectivo, transversal y descriptivo. Se evaluaron imágenes digitales de autofluorescencia retiniana de casos no comparativos con edema macular diabético no tratado, obtenidas y almacenadas con el sistema de cámara de flash.Se evaluó la variabilidad interobservador. RESULTADOS: Se incluyeron 37 ojos de 20 pacientes. La opacidad de medios fue la causa más común de calidad inadecuada de imagen. Se observaron cinco diferentes patrones de autofluorescencia retiniana: disminuida (13 %), normal (40 %), hiperautofluorescente unifocal (17 %), hiperautofluorescente multifocal (22 %) e hiperautofluorescente en placa (8 %). El coeficiente kappa fue de 0.906 (p = 0.000). CONCLUSIONES: En pacientes con edema macular diabético se presentan diferentes patrones fenotípicos de autofluorescencia retiniana con los sistemas de cámara de flash. Una clasificación fenotípica más precisa pudiera ayudar a establecer factores pronósticos de pérdida visual o al diseño de ensayos clínicos relativos a edema macular diabético.
Subject(s)
Diabetic Retinopathy/diagnostic imaging , Macular Edema/diagnostic imaging , Optical Imaging/instrumentation , Cataract , Cross-Sectional Studies , Female , Fundus Oculi , Humans , Male , Middle Aged , Observer Variation , Optical Imaging/classification , Optical Imaging/methods , Phenotype , Retrospective StudiesABSTRACT
The Food and Drug Administration (FDA or we) is classifying the wound autofluorescence imaging device into class I. We are taking this action because we have determined that classifying the device into class I will provide a reasonable assurance of safety and effectiveness of the device. We believe this action will also enhance patients' access to beneficial innovative devices, in part by reducing regulatory burdens.
