Georg Spital, Steffen Schmitz-Valckenberg, Bettina Müller, Erika Liczenczias, Petrus Chang, Britta Heimes-Bussmann, Focke Ziemssen, Sandra Liakopoulos
{"title":"糖尿病性黄斑水肿或视网膜静脉闭塞继发黄斑水肿患者在现实条件下的 SD-OCT 成像数据解读与标准化阅片中心的分析对比：ORCA 研究 24 个月的随访结果","authors":"Georg Spital, Steffen Schmitz-Valckenberg, Bettina Müller, Erika Liczenczias, Petrus Chang, Britta Heimes-Bussmann, Focke Ziemssen, Sandra Liakopoulos","doi":"10.1007/s00417-024-06579-7","DOIUrl":null,"url":null,"abstract":"<h3 data-test=\"abstract-sub-heading\">Purpose</h3><p>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).</p><h3 data-test=\"abstract-sub-heading\">Methods</h3><p>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.</p><h3 data-test=\"abstract-sub-heading\">Results</h3><p>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.</p><h3 data-test=\"abstract-sub-heading\">Conclusion</h3><p>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.</p><h3 data-test=\"abstract-sub-heading\">Trial registration</h3><p>www.clinicaltrials.gov, identifier NCT02194803.</p>","PeriodicalId":12748,"journal":{"name":"Graefe's Archive for Clinical and Experimental Ophthalmology","volume":"1 1","pages":""},"PeriodicalIF":0.0000,"publicationDate":"2024-09-19","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":"{\"title\":\"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\",\"authors\":\"Georg Spital, Steffen Schmitz-Valckenberg, Bettina Müller, Erika Liczenczias, Petrus Chang, Britta Heimes-Bussmann, Focke Ziemssen, Sandra Liakopoulos\",\"doi\":\"10.1007/s00417-024-06579-7\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<h3 data-test=\\\"abstract-sub-heading\\\">Purpose</h3><p>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).</p><h3 data-test=\\\"abstract-sub-heading\\\">Methods</h3><p>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.</p><h3 data-test=\\\"abstract-sub-heading\\\">Results</h3><p>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.</p><h3 data-test=\\\"abstract-sub-heading\\\">Conclusion</h3><p>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. 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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
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.
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