Design des ORCA-Moduls der OCEAN-Studie

Heimes, B.; Schick, Tina; Brinkmann, Christian; Wiedon, Annette; Haegele, Birgit; Kirchhof, Bernd; Holz, Frank G.; Pauleikhoff, Daniel; Ziemssen, Focke; Liakopoulos, Sandra; Spital, Georg; Schmitz-Valckenberg, Steffen

doi:10.1007/s00347-016-0224-x

Cited by 18 publications

(5 citation statements)

References 21 publications

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“…OCTs were evaluated using the Orca module , which assesses certain morphological OCT parameters listed in Table 2 [ 26 ]. Seventy-seven of the 164 eyes with BCVA of ≥ 1.3 logMAR were included in the OCT evaluation.…”

Section: Resultsmentioning

confidence: 99%

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Benefit of intravitreal injections in patients with sub-threshold baseline visual acuity: a retrospective single-centre study

Grimm

Fahimi

Kück

et al. 2023

Graefes Arch Clin Exp Ophthalmol

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Purpose To investigate the lower visual acuity threshold for recommending intravitreal injection therapy (IVI). The lower limit of 1.3 logMAR best-corrected visual acuity (BCVA) was adopted in 2006 and has been maintained since then. Methods In this retrospective study, data from patients with a logMAR BCVA ≤ 1.3 and 24 months follow-up were analysed. We included patients with neovascular age-related macular degeneration (nAMD), diabetic macular oedema (DME), or retinal vein occlusion (RVO). Results The data from 164 patients (nAMD: 107; DME: 15; RVO: 42) were analysed. We observed a significant improvement at all time intervals (0 to 6, 6 to 12, 12 to 18, and 18 to 24 months after initiating IVI) compared to baseline. Across all indications, median BCVA improved from 1.4 to 1.0 within the first 6 months and remained stable within 24 months. Patients received a median of 5 and 10 injections within 6 and 24 months, respectively. Median foveal retinal thickness was 594.5 μm at baseline and dropped to 244.5 μm, 235.5 µm, 183 µm, and 180 µm during the four consecutive time intervals. Conclusion Patients with nAMD, DME, and RVO with poor baseline BCVA may also benefit from intravitreal therapy with VEGF-inhibitors. In the present study, we observed functional and morphological improvement over 2 years irrespective of the underlying macular disease. Those patients should not be excluded from therapy.

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Section: Resultsmentioning

confidence: 99%

“…We also recorded the intravitreally administered medication, age, and gender. Furthermore, morphological OCT features were evaluated applying the OCT criteria from the Orca module of the Ocean study [ 26 ].…”

Section: Methodsmentioning

confidence: 99%

Benefit of intravitreal injections in patients with sub-threshold baseline visual acuity: a retrospective single-centre study

Grimm

Fahimi

Kück

et al. 2023

Graefes Arch Clin Exp Ophthalmol

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“…Although just “OCT” was written in the study protocol, the use of spectral domain (SD-OCT) had mostly replaced time domain machines (TD-OCT) during the period of the study [ 28 ]. Further evaluations must be awaited, which describe a subsequent second diagnosis of the images by several reading centres [ 29 , 30 ]. Hopefully, the results will shed some light on why patients were so rarely treated despite ophthalmologist visits and OCT examinations.…”

Section: Discussionmentioning

confidence: 99%

Use of Imaging Modalities in Real Life: Impact on Visual Acuity Outcomes of Ranibizumab Treatment for Neovascular Age-Related Macular Degeneration in Germany

Wachtlin

Spital

Schmitz-Valckenberg

et al. 2020

Journal of Ophthalmology

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Background. To date, there are limited prospective real-world data on the impact of optical coherence tomography (OCT) diagnostics on treatment outcomes in neovascular age-related macular degeneration (nAMD). Therefore, the prospective, noninterventional OCEAN study (NCT02194803) evaluated the use of OCT imaging and its impact on functional outcomes in Germany. Methods. The use of OCT imaging for treatment decisions was documented in nAMD patients receiving intravitreal ranibizumab injections at 347 study centres. Best-corrected visual acuity (BCVA) testing and treatment were performed according to routine clinical practice and documented over 24 months. Results. The majority of the 3,631 nAMD patients (59.6%) received a combination of OCT and fluorescein angiography imaging within the first 6 months. Over the remaining study course, this combination was used infrequently (range: 7.6% to 13.4%) and continually decreased over time; most patients received only OCT examinations (range: 48.9% to 52.5%; median: 3 within 12 months and 4 within 24 months). Subgroups according to the number of OCT examinations (≤4, rarely OCT examined; 5–8, moderately OCT examined; ≥8, well monitored) were associated with different treatment frequencies and outcomes: Rarely OCT-examined patients had received a median of 4 injections (range: 1–19) at 24 months; well-monitored patients had received a median of 8 injections (range: 1–21) at 24 months. Rarely OCT-examined patients had a mean change of BCVA of −0.3 letters (±26.1) at 24 months (n = 165); well-monitored patients showed a change of +2.0 letters (±20.8) at 24 months (n = 249). Time-to-response was greater for rarely examined than well-monitored patients, while duration-of-response was similar. Conclusion. Low number of visits as well as high number of treatment decisions without the use of OCT may contribute to undertreatment and poorer functional outcomes in patients undergoing ranibizumab treatment for nAMD in Germany. One potential reason for this could be that OCT was not covered by insurance for all patients during the study.

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“…The evaluation process of SD-OCT scans for the ORCA study have been previously described. 19 Further, adequacy of treatment indication by the clinician was assessed and possible reasons for suspected undertreatment or overtreatment were evaluated.…”

Section: Methodsmentioning

confidence: 99%

ORCA study: real-world versus reading centre assessment of disease activity of neovascular age-related macular degeneration (nAMD)

et al. 2020

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Background/aimsThe prospective, non-interventional ORCA module of the OCEAN study (Observation of Treatment Patterns with Lucentis in Approved Indications) evaluated the qualiy of spectral domain-optical coherence tomography (SD-OCT) image interpretation and treatment decisions by clinicians in Germany and the impact on visual outcomes over 24 months in patients with neovascular age-related macular degeneration (nAMD).Methods2286 SD-OCT scans of 205 eyes were independently evaluated by clinicians and reading centres (RCs) regarding signs of choroidal neovascularisation (CNV) activity, including presence of intraretinal fluid, subretinal fluid, and/or increase in pigment epithelial detachments. Agreement between clinicians and RCs was calculated. Treatment decisions by clinicians and the impact on treatment outcomes were evaluated.ResultsCNV activity was detected by RCs on 1578 scans (69.0%) and by clinicians on 1392 scans (60.9%), with agreement in 74.9% of cases. Of the 1578 scans with RC detected CNV activity, anti-vascular endothelial growth factor injections were performed by clinicians in only 35.5% (560/1578). In 19.7% of cases (311/1578), lack of treatment was justified by patients request, termination criteria or chronic cystoid spaces without other signs for CNV activity. In 44.8% of cases (707/1578) with RC detected CNV activity, clinicians claimed no treatment was necessary despite having correctly detected CNV activity in about 2/3 of these cases. In 34% of cases with presumed undertreatment, visual acuity declined in the following visit.ConclusionAlthough broad agreement on CNV activity parameters was observed between clinicians and RCs, correct identification of CNV activity did not always lead to the initiation of (re-)treatment. To preserve vision over time, correct interpretation of SD-OCT scans and careful retreatment decisions are required.Trial registration numberNCT02194803.

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Design des ORCA-Moduls der OCEAN-Studie

Cited by 18 publications

References 21 publications

Benefit of intravitreal injections in patients with sub-threshold baseline visual acuity: a retrospective single-centre study

Benefit of intravitreal injections in patients with sub-threshold baseline visual acuity: a retrospective single-centre study

Use of Imaging Modalities in Real Life: Impact on Visual Acuity Outcomes of Ranibizumab Treatment for Neovascular Age-Related Macular Degeneration in Germany

ORCA study: real-world versus reading centre assessment of disease activity of neovascular age-related macular degeneration (nAMD)

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