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Comparative Study
. 2025 Jan;263(1):131-139.
doi: 10.1007/s00417-024-06579-7. Epub 2024 Sep 19.

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

Georg Spital  1 , Steffen Schmitz-Valckenberg  2   3 , Bettina Müller  4 , Erika Liczenczias  4 , Petrus Chang  2 , Britta Heimes-Bussmann  1 , Focke Ziemssen  5   6 , Sandra Liakopoulos  7   8 ; ORCA study group
Affiliations
Comparative Study

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

Georg Spital et al. Graefes Arch Clin Exp Ophthalmol. 2025 Jan.

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).

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Conflict of interest statement

Declarations. Ethical approval: The OCEAN study was approved by the ethics committee of the Eberhard-Karls-University, Tuebingen, Germany. All procedures performed in studies involving human participants were in accordance with the ethical standards of the institutional and/or national research committee and with the 1964 Helsinki declaration and its later amendments or comparable ethical standards. Informed consent was obtained from all individual participants included in the study. Separate informed consent was required for patients to be included in the ORCA module. Consent to participate: Every patient was informed by the treating physician about the key objectives as well as the type and scope of the documentation. Eligible patients could only be included in the study after providing written informed consent, or, if incapable of doing so, after such consent had been provided by a legally acceptable representative of the patient. Consent for publication: Patients signed informed consent regarding publishing their data. Conflicts of interests: Georg Spital received personal fees from Bayer Healthcare, Novartis, Roche, OD-OS, and Allergan Pharma and grants from Amgen, Iveric Bio, Roche, Kodiak, Novartis, Novo-Nordisk, Gyroscope, Alexion. Steffen Schmitz-Valckenberg received contracts and personal fees for consultancy from Novartis as part of the submitted work. Outside the submitted work, he received grants or contracts from AlphaRET, Apellis, Bayer, Bioeq/Formycon, Carl Zeiss MediTec, Katairo, Kubota Vision, Novartis, Pixium, Roche/Genentech, SparingVision; Consulting fees from Apellis, Bioeq/Formycon, Galimedix, Novartis, Oxurion, Roche/Genentech; and nonfinancial support from Carl Zeiss Meditec and Heidelberg Engineering, outside the submitted work; being co-founder of the STZ GRADE Reading Centre. Bettina Müller and Erika Liczenczias are employees of Novartis. Petrus Chang received grants from Heidelberg Engineering, Novartis, ZeissMeditec. Britta Heimes-Bussmann received grants Amgen, Iveric Bio, Roche, Kodiak, Novartis, Novo-Nordisk, Gyroscope and personal fees von Bayer. Focke Ziemssen received research grants from Bayer, BMBF, Clearside, DFG, Kodiak, Iveric, Ophtea, Novartis, Regeneron, consulting fees from Alimera Sciences, Allergan/Abbvie, Bayer, Boehringer-Ingelheim, Novartis, NovoNordisk, MSD, Oxurion, Roche/Genentech, and fees as speaker from Alimera, Allergan/Abbvie, Bayer, BDI, CME Health, Gerling, Novartis, ODOS, Roche. Sandra Liakopoulos received grants from Novartis, personal fees from Novartis, Heidelberg Engineering, Carl Zeiss Meditec, Allergan/Abbvie, Bayer, Apellis, and consulting fees from Novartis, Bayer, Apellis and Allergan.

Figures

Fig. 1
Fig. 1
Agreement between physicians and RCs for the identification of IRF and SRF in complete SD-OCT volume scans of follow-up visits. Evaluations of the presence of IRF (on the left) and SRF (on the right) were compared. The percentages shown are calculated based on a 100% ‘Yes’ or 100% ‘No/questionable/cannot grade’ evaluation of the physician for each parameter. For some scans, information on the parameter was missing/not assessable by the physician or the RCs: intraretinal fluid, n = 8; subretinal fluid, n = 13. CG, cannot grade; NA, not assessable; IRF, intraretinal fluid; RC, reading centre; SD-OCT, spectral domain-optical coherence tomography; SRF, subretinal fluid
Fig. 2
Fig. 2
Identification of IRF/SRF parameters on SD-OCT scans and treatment decisions by physicians for 1612 scans with RC confirmed foveal IRF/SRF in the combined ME cohort (A); ORCA-DME cohort (B); ORCA-RVO cohort (C). Presumed reasons for decisions not to perform injection are presented. *In 79/110 fluid was considered clearly visible by RCs. **Intra- and/or subretinal fluid with foveal component was observed by the physician. ***Other reasons include reasons such as the injection was planned for a later visit, patient lost to follow-up, no further injections requested, therapy change, patient preferences, adverse events, and other reasons without further clarification. ****Missing information were classified under ‘Watch and wait’ justified to avoid over-estimating undertreatment. CSRT, Central subfield retinal thickness; DME, diabetic macular oedema; FCP, foveal centre point; IRF, intraretinal fluid; RC, reading centre; SD-OCT, spectral domain optical coherence tomography, SRF, subretinal fluid
See this image and copyright information in PMC

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