[Design of the ORCA module in the OCEAN study : Evaluation of SD-OCT results in daily routine practice]

Ophthalmologe. 2016 Jul;113(7):570-80. doi: 10.1007/s00347-016-0224-x.
[Article in German]


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.

Conclusion: 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.

Keywords: Age-related macular degeneration; Anti-VEGF; Diabetic macular edema; Optical coherence tomography; Retinal vein occlusion.

Publication types

  • Clinical Trial
  • Multicenter Study

MeSH terms

  • Blindness / diagnosis*
  • Blindness / drug therapy*
  • Blindness / epidemiology
  • Blindness / etiology
  • Diabetic Retinopathy / diagnosis
  • Diabetic Retinopathy / drug therapy
  • Fluorescein Angiography
  • Germany
  • Humans
  • Intravitreal Injections
  • Macular Degeneration / complications
  • Macular Degeneration / diagnosis
  • Macular Degeneration / drug therapy
  • Macular Edema / complications
  • Macular Edema / diagnosis
  • Macular Edema / drug therapy
  • Quality Assurance, Health Care
  • Ranibizumab / therapeutic use*
  • Retina / drug effects
  • Retinal Vein Occlusion / complications
  • Retinal Vein Occlusion / diagnosis
  • Retinal Vein Occlusion / drug therapy
  • Surveys and Questionnaires
  • Tomography, Optical Coherence*
  • Treatment Outcome
  • Vascular Endothelial Growth Factor A / antagonists & inhibitors*


  • VEGFA protein, human
  • Vascular Endothelial Growth Factor A
  • Ranibizumab