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Article ; Online: Inter and intradevice assessment of microperimetry testing in aging eyes.

Coulibaly, Leonard M / Mohamed, Hamza / Fuchs, Philipp / Schmidt-Erfurth, Ursula / Reiter, Gregor S

2024 Volume 14, Issue 1, Page(s) 1049

Abstract: Microperimetry (MP) is a psychometric examination combining retinal imaging and functional sensitivity testing with an increasing importance due to its potential use as clinical study outcome. We investigated the repeatability of pointwise retinal ... ...

Abstract	Microperimetry (MP) is a psychometric examination combining retinal imaging and functional sensitivity testing with an increasing importance due to its potential use as clinical study outcome. We investigated the repeatability of pointwise retinal sensitivity (PWS) on the most advanced commercially available MP devices under their standard setting in a healthy aging population. Two successive MP examinations on both MP-3 (NIDEK CO., Ltd., Gamagori, Japan) and MAIA (CenterVue S.p.A. (iCare), Padova, Italy) were performed on healthy aging subjects in a randomized order. PWS repeatability was analysed for different macular regions and age groups using Bland-Altmann coefficients of repeatability (CoR). A total of 3600 stimuli from 20 healthy individuals with a mean age of 70 (11) years were included. Mean CoR in dB were ±4.61 for MAIA and ±4.55 for MP-3 examinations. A lower repeatability (p=0.005) was detected in the central millimetre on MAIA examinations. Higher subject age was associated with a lower repeatability of PWS on both devices (both p=0.003). Intra-device correlation was good (MAIA: 0.79 [0.76-0.81]; MP-3: 0.72 [0.68-0.76]) whereas a moderate mean inter-device correlation (0.6 [0.55-0.65]) could be detected. In conclusion, older subjects and the foveal region are associated with a worse pointwise repeatability.
MeSH term(s)	Humans ; Aged ; Visual Field Tests ; Retina ; Aging ; Fovea Centralis ; Health Status
Language	English
Publishing date	2024-01-10
Publishing country	England
Document type	Journal Article
ZDB-ID	2615211-3
ISSN	2045-2322 ; 2045-2322
ISSN (online)	2045-2322
ISSN	2045-2322
DOI	10.1038/s41598-024-51539-0
Database	MEDical Literature Analysis and Retrieval System OnLINE

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Article ; Online: Progression Dynamics of Early versus Later Stage Atrophic Lesions in Nonneovascular Age-Related Macular Degeneration Using Quantitative OCT Biomarker Segmentation.

Coulibaly, Leonard M / Reiter, Gregor S / Fuchs, Philipp / Lachinov, Dmitrii / Leingang, Oliver / Vogl, Wolf-Dieter / Bogunovic, Hrvoje / Schmidt-Erfurth, Ursula

Ophthalmology. Retina

2023 Volume 7, Issue 9, Page(s) 762–770

Abstract: Purpose: To investigate the progression of geographic atrophy secondary to nonneovascular age-related macular degeneration in early and later stage lesions using artificial intelligence-based precision tools.: Design: Retrospective analysis of an ... ...

Abstract	Purpose: To investigate the progression of geographic atrophy secondary to nonneovascular age-related macular degeneration in early and later stage lesions using artificial intelligence-based precision tools. Design: Retrospective analysis of an observational cohort study. Subjects: Seventy-four eyes of 49 patients with ≥ 1 complete retinal pigment epithelial and outer retinal atrophy (cRORA) lesion secondary to age-related macular degeneration were included. Patients were divided between recently developed cRORA and lesions with advanced disease status. Methods: Patients were prospectively imaged by spectral-domain OCT volume scans. The study period encompassed 18 months with scheduled visits every 6 months. Growth rates of recent cRORA-converted lesions were compared with lesions in an advanced disease status using mixed effect models. Main outcome measures: The progression of retinal pigment epithelial loss (RPEL) was considered the primary end point. Secondary end points consisted of external limiting membrane disruption and ellipsoid zone loss. These pathognomonic imaging biomarkers were quantified using validated deep-learning algorithms. Further, the ellipsoid zone/RPEL ratio was analyzed in both study cohorts. Results: Mean (95% confidence interval [CI]) square root progression of recently converted lesions was 79.68 (95% CI, -77.14 to 236.49), 68.22 (95% CI, -101.21 to 237.65), and 84.825 (95% CI, -124.82 to 294.47) mm/half year for RPEL, external limiting membrane loss, and ellipsoid zone loss respectively. Mean square root progression of advanced lesions was 131.74 (95% CI, -22.57 to 286.05), 129.96 (95% CI, -36.67 to 296.59), and 116.84 (95% CI, -90.56 to 324.3) mm/half year for RPEL, external limiting membrane loss, and ellipsoid zone loss, respectively. RPEL (P = 0.038) and external limiting membrane disruption (P = 0.026) progression showed significant differences between the 2 study cohorts. Further recent converters had significantly (P < 0.001) higher ellipsoid zone/RPEL ratios at all time points compared with patients in an advanced disease status (1.71 95% CI, 1.12-2.28 vs. 1.14; 95% CI, 0.56-1.71). Conclusion: Early cRORA lesions have slower growth rates in comparison to atrophic lesions in advanced disease stages. Differences in growth dynamics may play a crucial role in understanding the pathophysiology of nonneovascular age-related macular degeneration and for the interpretation of clinical trials in geographic atrophy. Individual disease monitoring using artificial intelligence-based quantification paves the way toward optimized geographic atrophy management. Financial disclosure(s): The author(s) have no proprietary or commercial interest in any materials discussed in this article.
MeSH term(s)	Humans ; Geographic Atrophy/complications ; Retrospective Studies ; Artificial Intelligence ; Tomography, Optical Coherence/methods ; Disease Progression ; Retinal Pigment Epithelium/pathology ; Macular Degeneration/complications ; Biomarkers ; Atrophy
Chemical Substances	Biomarkers
Language	English
Publishing date	2023-05-09
Publishing country	United States
Document type	Observational Study ; Journal Article
ISSN	2468-6530
ISSN (online)	2468-6530
DOI	10.1016/j.oret.2023.05.004
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Article ; Online: Personalized treatment supported by automated quantitative fluid analysis in active neovascular age-related macular degeneration (nAMD)-a phase III, prospective, multicentre, randomized study: design and methods.

Coulibaly, Leonard M / Sacu, Stefan / Fuchs, Philipp / Bogunovic, Hrvoje / Faustmann, Georg / Unterrainer, Christian / Reiter, Gregor S / Schmidt-Erfurth, Ursula

Eye (London, England)

2022 Volume 37, Issue 7, Page(s) 1464–1469

Abstract: Introduction: In neovascular age-related macular degeneration (nAMD) the exact amount of fluid and its location on optical coherence tomography (OCT) have been defined as crucial biomarkers for disease activity and therapeutic decisions. Yet in the ... ...

Abstract	Introduction: In neovascular age-related macular degeneration (nAMD) the exact amount of fluid and its location on optical coherence tomography (OCT) have been defined as crucial biomarkers for disease activity and therapeutic decisions. Yet in the absence of quantitative evaluation tools, real-world care outcomes are disappointing. Artificial intelligence (AI) offers a practical option for clinicians to enhance point-of-care management by analysing OCT volumes in a short time. In this protocol we present the prospective implementation of an AI-algorithm providing automated real-time fluid quantifications in a clinical real-world setting. Methods: This is a prospective, multicentre, randomized (1:1) and double masked phase III clinical trial. Two-hundred-ninety patients with active nAMD will be randomized between a study arm using AI-supported fluid quantifications and another arm using conventional qualitative assessments, i.e. state-of-the-art disease management. The primary outcome is defined as the mean number of injections over 1 year. Change in BCVA is defined as a secondary outcome. Discussion: Automated measurement of fluid volumes in all retinal compartments such as intraretinal fluid (IRF), and subretinal fluid (SRF) will serve as an objective tool for clinical investigators on which to base retreatment decisions. Compared to qualitative fluid assessment, retreatment decisions will be plausible and less prone to error or large variability. The underlying hypothesis is that fluid should be treated, while residual persistent or stable amounts of fluid may not benefit from further therapy. Reducing injection numbers without diminishing the visual benefit will increase overall patient safety and relieve the burden for healthcare providers. Trial-registration: EudraCT-Number: 2019-003133-42.
MeSH term(s)	Humans ; Ranibizumab/therapeutic use ; Angiogenesis Inhibitors/therapeutic use ; Vascular Endothelial Growth Factor A/therapeutic use ; Artificial Intelligence ; Prospective Studies ; Precision Medicine ; Intravitreal Injections ; Tomography, Optical Coherence ; Subretinal Fluid ; Macular Degeneration/drug therapy
Chemical Substances	Ranibizumab (ZL1R02VT79) ; Angiogenesis Inhibitors ; Vascular Endothelial Growth Factor A
Language	English
Publishing date	2022-07-05
Publishing country	England
Document type	Randomized Controlled Trial ; Multicenter Study ; Clinical Trial, Phase III ; Journal Article
ZDB-ID	91001-6
ISSN	1476-5454 ; 0950-222X
ISSN (online)	1476-5454
ISSN	0950-222X
DOI	10.1038/s41433-022-02154-8
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Article: Deep survival modeling of longitudinal retinal OCT volumes for predicting the onset of atrophy in patients with intermediate AMD.

Rivail, Antoine / Vogl, Wolf-Dieter / Riedl, Sophie / Grechenig, Christoph / Coulibaly, Leonard M / Reiter, Gregor S / Guymer, Robyn H / Wu, Zhichao / Schmidt-Erfurth, Ursula / Bogunović, Hrvoje

Biomedical optics express

2023 Volume 14, Issue 6, Page(s) 2449–2464

Abstract: In patients with age-related macular degeneration (AMD), the risk of progression to late stages is highly heterogeneous, and the prognostic imaging biomarkers remain unclear. We propose a deep survival model to predict the progression towards the late ... ...

Abstract	In patients with age-related macular degeneration (AMD), the risk of progression to late stages is highly heterogeneous, and the prognostic imaging biomarkers remain unclear. We propose a deep survival model to predict the progression towards the late atrophic stage of AMD. The model combines the advantages of survival modelling, accounting for time-to-event and censoring, and the advantages of deep learning, generating prediction from raw 3D OCT scans, without the need for extracting a predefined set of quantitative biomarkers. We demonstrate, in an extensive set of evaluations, based on two large longitudinal datasets with 231 eyes from 121 patients for internal evaluation, and 280 eyes from 140 patients for the external evaluation, that this model improves the risk estimation performance over standard deep learning classification models.
Language	English
Publishing date	2023-05-02
Publishing country	United States
Document type	Journal Article
ZDB-ID	2572216-5
ISSN	2156-7085
ISSN	2156-7085
DOI	10.1364/BOE.487206
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Article ; Online: A Systematic Prospective Comparison of Fluid Volume Evaluation across OCT Devices Used in Clinical Practice.

Kostolna, Klaudia / Reiter, Gregor S / Frank, Sophie / Coulibaly, Leonard M / Fuchs, Philipp / Röggla, Veronika / Gumpinger, Markus / Leitner Barrios, Gabriel P / Mares, Virginia / Bogunovic, Hrvoje / Schmidt-Erfurth, Ursula

Ophthalmology science

2023 Volume 4, Issue 3, Page(s) 100456

Abstract: Objective: Treatment decisions in neovascular age-related macular degeneration (nAMD) are mainly based on subjective evaluation of OCT. The purpose of this cross-sectional study was to provide a comparison of qualitative and quantitative differences ... ...

Abstract	Objective: Treatment decisions in neovascular age-related macular degeneration (nAMD) are mainly based on subjective evaluation of OCT. The purpose of this cross-sectional study was to provide a comparison of qualitative and quantitative differences between OCT devices in a systematic manner. Design: Prospective, cross-sectional study. Subjects: One hundred sixty OCT volumes, 40 eyes of 40 patients with nAMD. Methods: Patients from clinical practice were imaged with 4 different OCT devices during one visit: (1) Spectralis Heidelberg; (2) Cirrus; (3) Topcon Maestro2; and (4) Topcon Triton. Intraretinal fluid (IRF), subretinal fluid (SRF), and pigment epithelial detachment (PED) were manually annotated in all cubes by trained human experts to establish fluid measurements based on expert-reader annotations. Intraretinal fluid, SRF, and PED volume were quantified in nanoliters (nL). Bland-Altman plots were created to analyze the agreement of measurements in the central 1 and 6 mm. The Friedman test was performed to test for significant differences in the central 1, 3, and 6 mm. Main outcome measures: Intraretinal fluid, SRF, and PED volume. Results: In the central 6 mm, there was a trend toward higher IRF and PED volumes in Spectralis images compared with the other devices and no differences in SRF volume. In the central 1 mm, the standard deviation of the differences ranged from ± 3 nL to ± 6 nL for IRF, from ± 3 nL to ± 4 nL for SRF, and from ± 7 nL to ± 10 nL for PED in all pairwise comparisons. Manually annotated IRF and SRF volumes showed no significant differences in the central 1 mm. Conclusions: Fluid volume quantification achieved excellent reliability in all 3 retinal compartments on images obtained from 4 OCT devices, particularly for clinically relevant IRF and SRF values. Although fluid volume quantification is reliable in all 4 OCT devices, switching OCT devices might lead to deviating fluid volume measurements with higher agreement in the central 1 mm compared with the central 6 mm, with highest agreement for SRF volume in the central 1 mm. Understanding device-dependent differences is essential for expanding the interpretation and implementation of pixel-wise fluid volume measurements in clinical practice and in clinical trials. Financial disclosures: Proprietary or commercial disclosure may be found in the Footnotes and Disclosures at the end of this article.
Language	English
Publishing date	2023-12-15
Publishing country	Netherlands
Document type	Journal Article
ISSN	2666-9145
ISSN (online)	2666-9145
DOI	10.1016/j.xops.2023.100456
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Conference proceedings: Hands-on-Erfahrungen im automatisierten Fluid-Management in der neovaskulären AMD

Frank, Sophie / Coulibaly, Leonard M. / Fuchs, Philipp / Whitby, Ariadne / Unterrainer, Christian / Bogunovic, Hrvoje / Reiter, Gregor / Schmidt-Erfurth, Ursula

2023 , Page(s) FP 3.9

Event/congress	35. Internationaler Kongress der Deutschen Ophthalmochirurgie (DOC); Nürnberg; 2023
Keywords	Medizin, Gesundheit
Publishing date	2023-06-13
Publisher	German Medical Science GMS Publishing House; Düsseldorf
Document type	Conference proceedings
DOI	10.3205/23doc026
Database	German Medical Science

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Article ; Online: Effect of posterior vitreous detachment on treat-and-extend versus monthly ranibizumab for neovascular age-related macular degeneration.

Waldstein, Sebastian M / Coulibaly, Leonard / Riedl, Sophie / Sadeghipour, Amir / Gerendas, Bianca S / Schmidt-Erfurth, Ursula Margarethe

The British journal of ophthalmology

2019 Volume 104, Issue 7, Page(s) 899–903

Abstract: Aims: To investigate the impact of posterior vitreous detachment (PVD) on the efficacy of treat-and-extend (T&E) ranibizumab in neovascular age-related macular degeneration.: Methods: In a post hoc analysis of a randomised controlled clinical trial, ... ...

Abstract	Aims: To investigate the impact of posterior vitreous detachment (PVD) on the efficacy of treat-and-extend (T&E) ranibizumab in neovascular age-related macular degeneration. Methods: In a post hoc analysis of a randomised controlled clinical trial, spectral-domain optical coherence tomography images of treatment-naïve patients randomised to receive T&E (n=265) or monthly (n=264) ranibizumab for 12 months were included. Certified, masked graders diagnosed the presence or the absence of complete PVD. The main outcome measures were the mean change in best-corrected visual acuity (BCVA) and central retinal thickness (CRT) at month 12, the number of administered ranibizumab injections and the proportion of patients extended to more than 8 weeks. Results: At baseline, complete PVD was present in 51% and 56% of patients in the monthly and T&E arms, respectively. Mean change in BCVA at month 12 was +9.0 (PVD) vs +9.5 letters (no PVD, p=0.78) in monthly treated eyes, and +6.0 (PVD) vs +7.5 letters (no PVD, p=0.42) in T&E treated eyes. Conversely, mean change in CRT at month 12 was -174 (PVD) vs -173 µm (no PVD, p=0.98) in the monthly arm, and -175 (PVD) vs -164 µm (no PVD, p=0.58) in the T&E arm. In T&E treated patients, the median number of injections was eight vs nine (p=0.035). 71% of PVD eyes were extended successfully, compared with 55% of eyes without PVD (p=0.005). Conclusion: PVD was not found to impact functional and anatomical outcomes of T&E ranibizumab therapy. However, patients without a complete PVD required more retreatments and were significantly less likely to be successfully extended. Trial registration number: NCT01948830.
MeSH term(s)	Aged ; Aged, 80 and over ; Angiogenesis Inhibitors/administration & dosage ; Angiogenesis Inhibitors/therapeutic use ; Choroidal Neovascularization/diagnosis ; Choroidal Neovascularization/drug therapy ; Choroidal Neovascularization/physiopathology ; Double-Blind Method ; Female ; Humans ; Intravitreal Injections ; Male ; Middle Aged ; Prospective Studies ; Ranibizumab/administration & dosage ; Ranibizumab/therapeutic use ; Retina/physiopathology ; Tomography, Optical Coherence ; Treatment Outcome ; Vascular Endothelial Growth Factor A/antagonists & inhibitors ; Visual Acuity/physiology ; Vitreous Detachment/diagnostic imaging ; Vitreous Detachment/physiopathology ; Wet Macular Degeneration/diagnosis ; Wet Macular Degeneration/drug therapy ; Wet Macular Degeneration/physiopathology
Chemical Substances	Angiogenesis Inhibitors ; VEGFA protein, human ; Vascular Endothelial Growth Factor A ; Ranibizumab (ZL1R02VT79)
Language	English
Publishing date	2019-09-28
Publishing country	England
Document type	Clinical Trial, Phase III ; Journal Article ; Multicenter Study ; Randomized Controlled Trial ; Research Support, Non-U.S. Gov't
ZDB-ID	80078-8
ISSN	1468-2079 ; 0007-1161
ISSN (online)	1468-2079
ISSN	0007-1161
DOI	10.1136/bjophthalmol-2019-314661
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Article ; Online: Inter and intradevice assessment of microperimetry testing in aging eyes.

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Article ; Online: Progression Dynamics of Early versus Later Stage Atrophic Lesions in Nonneovascular Age-Related Macular Degeneration Using Quantitative OCT Biomarker Segmentation.

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Article ; Online: Personalized treatment supported by automated quantitative fluid analysis in active neovascular age-related macular degeneration (nAMD)-a phase III, prospective, multicentre, randomized study: design and methods.

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Article: Deep survival modeling of longitudinal retinal OCT volumes for predicting the onset of atrophy in patients with intermediate AMD.

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Article ; Online: A Systematic Prospective Comparison of Fluid Volume Evaluation across OCT Devices Used in Clinical Practice.

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Conference proceedings: Hands-on-Erfahrungen im automatisierten Fluid-Management in der neovaskulären AMD

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Article ; Online: Effect of posterior vitreous detachment on treat-and-extend versus monthly ranibizumab for neovascular age-related macular degeneration.

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