Evidence map›Paper›PMID 39294392›Full record

ArticleGraefe's archive for clinical and experimental ophthalmology = Albrecht von Graefes Archiv fur klinische und experimentelle Ophthalmologie2025

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, Steffen Schmitz-Valckenberg, Bettina Müller, Erika Liczenczias, Petrus Chang, Britta Heimes-Bussmann, Focke Ziemssen, Sandra Liakopoulos, ORCA study group

Registry-linked trialAbstract readMulticenter StudyComparative Study
In one paragraph

Article in Graefe's archive for clinical and experimental ophthalmology = Albrecht von Graefes Archiv fur klinische und experimentelle Ophthalmologie, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02194803 (Observation of Treatment Patterns With Lucentis and Real Life Ophthalmic Monitoring, Including Optional OCT in Approved Indications), which is not on this map. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT02194803 completednot on this map

Observation of Treatment Patterns With Lucentis and Real Life Ophthalmic Monitoring, Including Optional OCT in Approved Indications

TypeobservationalSponsorNovartis PharmaceuticalsRan2011 to 2016Enrolled5,778ConditionsNeovascular AMD, Visual Impairment Due to DME, Visual Impairment Due to Macular Oedema Secondary to Branch or Central RVO, Visual Impairment Due to CNV
3 · Its place in the literature

Who cites it

2 citing papers in PubMed.

  1. Article
  2. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

9 authors.

Georg SpitalM3 Reading Centre, Eye Centre at the St. Franziskus Hospital, Münster, Germany.
Steffen Schmitz-ValckenbergGRADE Reading Centre, Department of Ophthalmology, University of Bonn, Bonn, Germany.
Bettina MüllerNovartis Pharma GmbH, Nuremberg, Germany.
Erika LiczencziasNovartis Pharma GmbH, Nuremberg, Germany.
Petrus ChangGRADE Reading Centre, Department of Ophthalmology, University of Bonn, Bonn, Germany.
Britta Heimes-BussmannM3 Reading Centre, Eye Centre at the St. Franziskus Hospital, Münster, Germany.
Focke ZiemssenCentre for Ophthalmology, Eberhard Karls University, Tübingen, Germany.
Sandra LiakopoulosCologne Image Reading Centre, Department of Ophthalmology, Faculty of Medicine and University Hospital Cologne, Cologne, Germany. sandra.liakopoulos@uk-koeln.de.ORCID http://orcid.org/0000-0003-3539-4372
ORCA study group

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

purposeAs 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).

methodsPresence 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.

resultsFor 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.

conclusionDespite 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 registrationwww. CLINICALTRIALS: gov , identifier NCT02194803.

Indexed as

Diabetic RetinopathyMacula LuteaMacular EdemaRetinal Vein OcclusionTomography, Optical CoherenceVisual AcuityAgedAngiogenesis InhibitorsFemaleFluorescein AngiographyFollow-Up StudiesFundus OculiHumansIntravitreal InjectionsMaleMiddle AgedAngiogenesis InhibitorsAnti-VEGFDiabetic macular oedema (DME)Macular oedema (ME)Retinal vein occlusion (RVO)Spectral Domain Optical coherence tomography (SD-OCT)

Identifiers

PMID39294392
PMCPMC11807050

What Socratic holds

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LicenceCC BY
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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the Socratic graph.