title: [Design of the ORCA module in the OCEAN study : Evaluation of SD-OCT results in daily routine practice].
abstract: BACKGROUND
  The prevalence of blindness as defined by law could be reduced by the introduction of anti-vascular endothelial growth factor (VEGF) therapy. Because the treatment is governed by patient needs, mostly using morphological criteria, imaging diagnostics are of particular importance. The non-interventional OCEAN study investigates the treatment with ranibizumab in the clinical routine practice. In a subgroup of patients the interpretation of spectral domain optical coherence tomography (SD-OCT) scans by the treating physicians will be analyzed (ORCA module).
  
  
  METHODS
  Over a period of 24 months data from patients with exudative age-related macular degeneration (AMD), macular edema due to retinal vein occlusion or diabetes mellitus, who are receiving intravitreal injections of ranibizumab, will be assessed. Information on examinations, visual acuity, treatment and recordings from imaging techniques will be documented using a questionnaire. The SD-OCT scans, fluorescence angiography and fundus photography will be independently analyzed by the ophthalmologist of the study center and by three reading centers (CIRCL Cologne, GRADE Bonn and M3 Münster). Automated measurements of retinal thickness by the manufacturers' software will be checked and if necessary manually corrected. A qualitative interpretation in terms of morphological criteria for (further) treatment will be performed.
  
  
  CONCLUSIONS
  A thorough assessment of SD-OCT images during anti-VEGF therapy provides the basis for the best possible needs-oriented treatment regimen. The control of the quality of data from daily routine practice may indicate possible weaknesses allowing explicit training and therefore optimization of patient treatment.
authors: M3 Reading Center, Augenabteilung am St. Franziskus-Hospital Münster, Münster, Deutschland.
authors: B
authors: B
authors: Heimes
authors: Cologne Image Reading Center, Zentrum für Augenheilkunde, Uniklinik Köln, Kerpener Str. 62, 50924, Köln, Deutschland.
authors: T
authors: T
authors: Schick
authors: GRADE Reading Center, Universitäts-Augenklinik Bonn, Bonn, Deutschland.
authors: C K
authors: CK
authors: Brinkmann
authors: Novartis Pharma GmbH Nürnberg, Nürnberg, Deutschland.
authors: A
authors: A
authors: Wiedon
authors: Novartis Pharma GmbH Nürnberg, Nürnberg, Deutschland.
authors: B
authors: B
authors: Haegele
authors: Cologne Image Reading Center, Zentrum für Augenheilkunde, Uniklinik Köln, Kerpener Str. 62, 50924, Köln, Deutschland.
authors: B
authors: B
authors: Kirchhof
authors: GRADE Reading Center, Universitäts-Augenklinik Bonn, Bonn, Deutschland.
authors: F G
authors: FG
authors: Holz
authors: M3 Reading Center, Augenabteilung am St. Franziskus-Hospital Münster, Münster, Deutschland.
authors: D
authors: D
authors: Pauleikhoff
authors: Universitäts-Augenklinik Tübingen, Tübingen, Deutschland.
authors: F
authors: F
authors: Ziemssen
authors: Cologne Image Reading Center, Zentrum für Augenheilkunde, Uniklinik Köln, Kerpener Str. 62, 50924, Köln, Deutschland. sandra.liakopoulos@uk-koeln.de.
authors: S
authors: S
authors: Liakopoulos
authors: M3 Reading Center, Augenabteilung am St. Franziskus-Hospital Münster, Münster, Deutschland.
authors: G
authors: G
authors: Spital
authors: GRADE Reading Center, Universitäts-Augenklinik Bonn, Bonn, Deutschland.
authors: S
authors: S
authors: Schmitz-Valckenberg
mesh_terms: D001766:Blindness / Q000175:diagnosis* / Q000188:drug therapy* / Q000453:epidemiology / Q000209:etiology; D003930:Diabetic Retinopathy / Q000175:diagnosis / Q000188:drug therapy; D005451:Fluorescein Angiography; D005858:Germany; D006801:Humans; D058449:Intravitreal Injections; D008268:Macular Degeneration / Q000150:complications / Q000175:diagnosis / Q000188:drug therapy; D008269:Macular Edema / Q000150:complications / Q000175:diagnosis / Q000188:drug therapy; D011785:Quality Assurance, Health Care; D000069579:Ranibizumab / Q000627:therapeutic use*; D012160:Retina / Q000187:drug effects; D012170:Retinal Vein Occlusion / Q000150:complications / Q000175:diagnosis / Q000188:drug therapy; D011795:Surveys and Questionnaires; D041623:Tomography, Optical Coherence; D016896:Treatment Outcome; D042461:Vascular Endothelial Growth Factor A / Q000037:antagonists & inhibitors*
chemical_list: C467484:VEGFA protein, human; D042461:Vascular Endothelial Growth Factor A; D000069579:Ranibizumab
keywords: Age-related macular degeneration; Anti-VEGF; Diabetic macular edema; Optical coherence tomography; Retinal vein occlusion