Interpretation of SD-OCT imaging data in real-life conditions versus standardized reading centre analysis in eyes with diabetic macular oedema or macular oedema secondary to retinal vein occlusion: 24-month follow-up of the ORCA study

Graefes Arch Clin Exp Ophthalmol. 2025 Jan;263(1):131-139. doi: 10.1007/s00417-024-06579-7. Epub 2024 Sep 19.

Abstract

Purpose: As part of the prospective, non-interventional OCEAN study, the ORCA module evaluated physicians' spectral domain optical coherence tomography (SD-OCT) image interpretations in the treatment of diabetic macular oedema (DME) or macular oedema (ME) secondary to retinal vein occlusion (RVO).

Methods: Presence of intraretinal fluid (IRF) and/or subretinal fluid (SRF) was evaluated independently by physicians and reading centres (RCs) on 1612 SD-OCT scans of 133 patients diagnosed with either DME or ME secondary to RVO. Agreement between physicians and RCs was calculated for both cohorts individually and as a combined ME cohort. Physicians' treatment decisions were analysed related to the results of the OCT-evaluations.

Results: For the combined ME cohort, presence of IRF/SRF was recorded by RCs in 792/1612 (49.1%) visits and by physicians in 852/1612 (52.9%) visits, with an agreement regarding presence or absence of foveal fluid in 70.4% of cases. In 64.4% (510/792) of visits with RC-detected foveal IRF and/or SRF no injection was given. In 30.3% of these visits with foveal fluid no reason was identified for a 'watch and wait' approach indicating possible undertreatment. BCVA deterioration was seen in a quarter of these eyes at the following visit.

Conclusion: Despite good agreement between physicians and RCs to recognize SRF and IRF, our data indicate that omitting injections despite foveal involvement of fluid is frequent in routine clinical practice. This may put patients at risk of undertreatment, which may negatively impact real-life BCVA outcomes.

Trial registration: www.

Clinicaltrials: gov , identifier NCT02194803.

Keywords: Anti-VEGF; Diabetic macular oedema (DME); Macular oedema (ME); Retinal vein occlusion (RVO); Spectral Domain Optical coherence tomography (SD-OCT).

Publication types

  • Multicenter Study
  • Comparative Study

MeSH terms

  • Aged
  • Angiogenesis Inhibitors / administration & dosage
  • Diabetic Retinopathy* / complications
  • Diabetic Retinopathy* / diagnosis
  • Diabetic Retinopathy* / drug therapy
  • Diabetic Retinopathy* / etiology
  • Female
  • Fluorescein Angiography / methods
  • Follow-Up Studies
  • Fundus Oculi
  • Humans
  • Intravitreal Injections
  • Macula Lutea* / pathology
  • Macular Edema* / diagnosis
  • Macular Edema* / drug therapy
  • Macular Edema* / etiology
  • Male
  • Middle Aged
  • Prospective Studies
  • Retinal Vein Occlusion* / complications
  • Retinal Vein Occlusion* / diagnosis
  • Subretinal Fluid / diagnostic imaging
  • Time Factors
  • Tomography, Optical Coherence* / methods
  • Visual Acuity*

Substances

  • Angiogenesis Inhibitors

Associated data

  • ClinicalTrials.gov/NCT02194803