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3. Eye Scan Ultrasound System for Automatic Cataract Detection: From a Preclinical to a Clinical Prototype

Author

Petrella, Lorena, Gomes, Marco, Perdigão, Fernando, Santos, Mario, Fernandes, Paulo, Pinto, Carlos, Nunes, Sandrina, Morgado, Miguel, Caixinha, Miguel, Santos, Jaime, Magjarevic, Ratko, Series Editor, Ładyżyński, Piotr, Associate Editor, Ibrahim, Fatimah, Associate Editor, Lackovic, Igor, Associate Editor, Rock, Emilio Sacristan, Associate Editor, Henriques, Jorge, editor, Neves, Nuno, editor, and de Carvalho, Paulo, editor

Published
2020
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9. Associations with intraocular pressure across Europe: The European Eye Epidemiology (E3) Consortium

Author

Khawaja, Anthony P., Springelkamp, Henriët, Creuzot-Garcher, Catherine, Delcourt, Cécile, Hofman, Albert, Höhn, René, Iglesias, Adriana I., Wolfs, Roger C. W., Korobelnik, Jean-François, Silva, Rufino, Topouzis, Fotis, Williams, Katie M., Bron, Alain M., Buitendijk, Gabriëlle H. S., Cachulo, Maria da Luz, Cougnard-Grégoire, Audrey, Dartigues, Jean-François, Hammond, Christopher J., Pfeiffer, Norbert, Salonikiou, Angeliki, van Duijn, Cornelia M., Vingerling, Johannes R., Luben, Robert N., Mirshahi, Alireza, Lamparter, Julia, Klaver, Caroline C. W., Jansonius, Nomdo M., Foster, Paul J., Acar, Niyazi, Anastosopoulos, Eleftherios, Azuara-Blanco, Augusto, Bergen, Arthur, Bertelsen, Geir, Binquet, Christine, Bird, Alan, Brétillon, Lionel, Bron, Alain, Buitendijk, Gabrielle, Cachulo, Maria Luz, Chakravarthy, Usha, Chan, Michelle, Chang, Petrus, Colijn, Annemarie, Cougnard-Grégoire, Audrey, Creuzot-Garcher, Catherine, Cumberland, Philippa, Cunha-Vaz, José, Daien, Vincent, Deak, Gabor, Delcourt, Cécile, Delyfer, Marie-Noëlle, Hollander, Anneke den, Dietzel, Martha, Erke, Maja Gran, Fauser, Sascha, Finger, Robert, Fletcher, Astrid, Foster, Paul, Founti, Panayiota, Göbel, Arno, Gorgels, Theo, Grauslund, Jakob, Grus, Franz, Hammond, Christopher, Helmer, Catherine, Hense, Hans-Werner, Hermann, Manuel, Hoehn, René, Hogg, Ruth, Holz, Frank, Hoyng, Carel, Jansonius, Nomdo, Janssen, Sarah, Khawaja, Anthony, Klaver, Caroline, Korobelnik, Jean-François, Lamparter, Julia, Le Goff, Mélanie, Leal, Sergio, Lechanteur, Yara, Lehtimäki, Terho, Lotery, Andrew, Leung, Irene, Mauschitz, Matthias, Merle, Bénédicte, Meyer zu Westrup, Verena, Midena, Edoardo, Miotto, Stefania, Mirshahi, Alireza, Mohan-Saïd, Sadek, Muldrew, Alyson, Mueller, Michael, Nunes, Sandrina, Oexle, Konrad, Peto, Tunde, Piermarocchi, Stefano, Prokofyeva, Elena, Rahi, Jugnoo, Raitakari, Olli, Ribeiro, Luisa, Rougier, Marie-Bénédicte, Sahel, José, Salonikiou, Aggeliki, Sanchez, Clarisa, Schmitz-Valckenberg, Steffen, Schweitzer, Cédric, Segato, Tatiana, Shehata, Jasmin, Silva, Rufino, Silvestri, Giuliana, Simader, Christian, Souied, Eric, Springelkamp, Henriet, Tapp, Robyn, Topouzis, Fotis, Verhoeven, Virginie, Von Hanno, Therese, Vujosevic, Stela, Williams, Katie, Wolfram, Christian, Yip, Jennifer, Zerbib, Jennyfer, Zwiener, Isabella, and On behalf of the European Eye Epidemiology (E³) Consortium

Published
2016
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10. Development of a Genotype Assay for Age-Related Macular Degeneration: The EYE-RISK Consortium

Author

de Breuk, Anita, Acar, Ilhan E., Kersten, Eveline, Schijvenaars, Mascha M.V.A.P., Colijn, Johanna M., Haer-Wigman, Lonneke, Bakker, Bjorn, de Jong, Sarah, Meester-Smoor, Magda A., Verzijden, Timo, Missotten, Tom O.A.R., Monés, Jordi, Biarnés, Marc, Pauleikhoff, Daniel, Hense, Hans W., Silva, Rufino, Nunes, Sandrina, Melo, Joana B., Fauser, Sascha, Hoyng, Carel B., Ueffing, Marius, Coenen, Marieke J.H., Klaver, Caroline C.W., den Hollander, Anneke I., Ikram, A., Vingerling, Johannes, Ophthalmology, and Epidemiology

Subjects
genetic structures, sense organs, eye diseases
Abstract

Purpose: To develop a genotype assay to assess associations with common and rare age-related macular degeneration (AMD) risk variants, to calculate an overall genetic risk score (GRS), and to identify potential misdiagnoses with inherited macular dystrophies that mimic AMD. Design: Case-control study. Participants: Individuals (n = 4740) from 5 European cohorts. Methods: We designed single-molecule molecular inversion probes for target selection and used next generation sequencing to sequence 87 single nucleotide polymorphisms (SNPs), coding and splice-site regions of 10 AMD-(related) genes (ARMS2, C3, C9, CD46, CFB, CFH, CFI, HTRA1, TIMP3, and SLC16A8), and 3 genes that cause inherited macular dystrophies (ABCA4, CTNNA1, and PRPH2). Genetic risk scores for common AMD risk variants were calculated based on effect size and genotype of 52 AMD-associated variants. Frequency of rare variants was compared between late AMD patients and control individuals with logistic regression analysis. Main Outcome Measures: Genetic risk score, association of genetic variants with AMD, and genotype–phenotype correlations. Results: We observed high concordance rates between our platform and other genotyping platforms for the 69 successfully genotyped SNPs (>96%) and for the rare variants (>99%). We observed a higher GRS for patients with late AMD compared with patients with early/intermediate AMD (P < 0.001) and individuals without AMD (P < 0.001). A higher proportion of pathogenic variants in the CFH (odds ratio [OR] = 2.88; P = 0.006), CFI (OR = 4.45; P = 0.005), and C3 (OR = 6.56; P = 0.0003) genes was observed in late AMD patients compared with control individuals. In 9 patients, we identified pathogenic variants in the PRPH2, ABCA4, and CTNNA1 genes, which allowed reclassification of these patients as having inherited macular dystrophy. Conclusions: This study reports a genotype assay for common and rare AMD genetic variants, which can identify individuals at intermediate to high genetic risk of late AMD and enables differential diagnosis of AMD-mimicking dystrophies. Our study supports sequencing of CFH, CFI, and C3 genes because they harbor rare high-risk variants. Carriers of these variants could be amendable for new treatments for AMD that currently are under development.

Published
2021

11. Efficacy and safety of Intravitreal Aflibercept Vs Verteporfin Photodynamic Therapy in a Caucasian Population with Polypoidal Choroidal Vasculopathy: A Randomized Clinical Trial

Author

Silva, Rufino, Arias, Luis, Nunes, Sandrina, Farinha, Claudia, Coimbra, Rita, Maques, João P., Cachulo, Maria L., Figueira, João, Barreto, Patricia, Madeira, Maria H., Pires, Isabel, Sousa, João C., Distefano, Laura, Rosa, Paulo, Carneiro, Ângela, Vaz Pereira, Sara, Meireles, Angelina, Cabrera, Francisco, Bures, Anniken, Mendonça, Luís, Fernandez-Vega Sanz, Alvaro, Barrão, Sandra, Koh, Adrian, Cheung, Chui Ming Gemmy, Cunha Vaz, José G., Murta, Joaquim, and EVICR.net ATLANTIC Study Group

Subjects
Clinical trials, Assaigs clinics, Polyps (Pathology), Pòlips (Patologia), Malalties vasculars, Vascular diseases, Assaigs clínics
Abstract

Importance: Polypoidal choroidal vasculopathy (PCV) is far less common and studied in a Caucasian population than in an Asian population, and the optimal treatment approach remains to be confirmed. Methods: A 52-week, double-masked, sham-controlled, phase 4, investigator-initiated randomized clinical trial (RCT) in naive symptomatic Caucasian patients with PCV treated with aflibercept in a treat-and-extend regimen (T&E) (intravitreal aflibercept injection [IVAI] T&E). Patients were randomized at week 16 to receive IVAI T&E plus either sham photodynamic therapy (PDT) or standard fluence PDT with verteporfin. The main outcome measures were changes in best-corrected visual acuity (BCVA) from baseline to 52 weeks and polyp occlusion at week 52. Data are presented as median (interquartile range [IQR]) for BCVA, number of IVAI, and change in central retinal thickness (CRT). Results: Of the 50 patients included in the study, 48 patients completed the 52 weeks of follow-up. During this period, a significant median (IQR) BCVA gain of 6 [2-12] Early Treatment Diabetic Retinopathy Study letters was observed for all patients (p < 0.001), after 8 (7-9) injections, with a significant reduction of -93.0 [-154.0, -44.0] mu m in central macular thickness (p < 0.001). Using indocyanine green angiography, a complete occlusion of polypoidal lesions was documented in 72% of the cases. Still, no significant difference was detected between the sham PDT and the aflibercept PDT arms, at week 52, for BCVA change (6.5 [2-11] vs. 5 [2-13] letters (p = 0.98)), number of IVAIs (8.5 [7-9] vs. 8 [7-9] (p = 0.21)), change in CRT (-143 [-184; -47] vs. -89 [-123; -41.5] mu m [p = 0.23]), and rates of complete polyp occlusion: 77 versus 68% (p = 0.53) or presence of fluid: 68 versus 57% (p = 0.56). No serious ocular adverse events were registered in the 2 arms. Conclusions and Relevance: To our knowledge, this is the first RCT to compare aflibercept T&E monotherapy with aflibercept T&E plus verteporfin PDT in a Caucasian population with PCV. Aflibercept monotherapy in a T&E showed to be effective and safe with a significant median BCVA improvement of 6 letters and a complete occlusion of polypoidal lesions in near 3 quarters of the eyes, at 1 year. As only 22% of the eyes underwent PDT treatment, the benefit of combined treatment for PCV in Caucasian patients could not be definitively elucidated from this study.

Published
2021

12. Development of a Genotype Assay for Age-Related Macular Degeneration:The EYE-RISK Consortium

Author

de Breuk, Anita, Acar, Ilhan E., Kersten, Eveline, Schijvenaars, Mascha M.V.A.P., Colijn, Johanna M., Haer-Wigman, Lonneke, Bakker, Bjorn, de Jong, Sarah, Meester-Smoor, Magda A., Verzijden, Timo, Missotten, Tom O.A.R., Monés, Jordi, Biarnés, Marc, Pauleikhoff, Daniel, Hense, Hans W., Silva, Rufino, Nunes, Sandrina, Melo, Joana B., Fauser, Sascha, Hoyng, Carel B., Ueffing, Marius, Coenen, Marieke J.H., Klaver, Caroline C.W., den Hollander, Anneke I., Ikram, A., Vingerling, Johannes, de Breuk, Anita, Acar, Ilhan E., Kersten, Eveline, Schijvenaars, Mascha M.V.A.P., Colijn, Johanna M., Haer-Wigman, Lonneke, Bakker, Bjorn, de Jong, Sarah, Meester-Smoor, Magda A., Verzijden, Timo, Missotten, Tom O.A.R., Monés, Jordi, Biarnés, Marc, Pauleikhoff, Daniel, Hense, Hans W., Silva, Rufino, Nunes, Sandrina, Melo, Joana B., Fauser, Sascha, Hoyng, Carel B., Ueffing, Marius, Coenen, Marieke J.H., Klaver, Caroline C.W., den Hollander, Anneke I., Ikram, A., and Vingerling, Johannes

Abstract

Purpose: To develop a genotype assay to assess associations with common and rare age-related macular degeneration (AMD) risk variants, to calculate an overall genetic risk score (GRS), and to identify potential misdiagnoses with inherited macular dystrophies that mimic AMD. Design: Case-control study. Participants: Individuals (n = 4740) from 5 European cohorts. Methods: We designed single-molecule molecular inversion probes for target selection and used next generation sequencing to sequence 87 single nucleotide polymorphisms (SNPs), coding and splice-site regions of 10 AMD-(related) genes (ARMS2, C3, C9, CD46, CFB, CFH, CFI, HTRA1, TIMP3, and SLC16A8), and 3 genes that cause inherited macular dystrophies (ABCA4, CTNNA1, and PRPH2). Genetic risk scores for common AMD risk variants were calculated based on effect size and genotype of 52 AMD-associated variants. Frequency of rare variants was compared between late AMD patients and control individuals with logistic regression analysis. Main Outcome Measures: Genetic risk score, association of genetic variants with AMD, and genotype–phenotype correlations. Results: We observed high concordance rates between our platform and other genotyping platforms for the 69 successfully genotyped SNPs (>96%) and for the rare variants (>99%). We observed a higher GRS for patients with late AMD compared with patients with early/intermediate AMD (P < 0.001) and individuals without AMD (P < 0.001). A higher proportion of pathogenic variants in the CFH (odds ratio [OR] = 2.88; P = 0.006), CFI (OR = 4.45; P = 0.005), and C3 (OR = 6.56; P = 0.0003) genes was observed in late AMD patients compared with control individuals. In 9 patients, we identified pathogenic variants in the PRPH2, ABCA4, and CTNNA1 genes, which allowed reclassification of these patients as having inherited macular dystrophy. Conclusions: This study reports a genotype assay for common and rare AMD genetic variants, which can identify individuals at interm

Published
2021

13. Nutritional Patterns using Principal Component Analysis and Their Associations with Age-Related Macular Degeneration. The Coimbra Eye Study – Report 7

Author

Nunes, Sandrina, Coimbra, Rita, Barreto, Patrícia, Rodrigues, João, Almeida, Carlos, Raimundo, Miguel, Simões, Sonia, Cachulo, Maria Da Luz, Santos, Lèlita, and Silva, Rufino

Abstract

Journal of Statistics on Health Decision, vol. 2 n.º 2 (2020): Special Issue - Statistics on Health Decision Making: clinical trials

Published
2020

15. Development of a Genotype Assay for Age-Related Macular Degeneration: The EYE-RISK Consortium

Author

Breuk, Anita de, Acar, Ilhan E., Kersten, Eveline, Schijvenaars, Mascha M. V. A. P., Colijn, Johanna M., Haer-Wigman, Lonneke, Bakker, Bjorn, Jong, Sarah de, Meester-Smoor, Magda, Verzijden, Timo, Missotten, Tom O. A. R., Monés, Jordi, Biarnés, Marc, Pauleikhoff, Daniel, Hense, Hans W., Silva, Rufino, Nunes, Sandrina, Melo, Joana B., Fauser, Sascha, Hoyng, Carel B., Ueffing, Marius, Coenen, Marieke J. H., Klaver, Caroline C. W., and Hollander, Anneke I. den

Subjects
Genetic testing, Age-related macular degeneration, Genetics, eye diseases, Genetic counseling
Abstract

The EYE-RISK Consortium: Université Bordeaux, Inserm, Bordeaux Population Health Research Center, Bordeaux, France: Soufiane Ajana, Audrey Cougnard-Grégoire, Cécile Delcourt, Bénédicte M. J. Merle; Institute for Ophthalmic Research, Eberhard Karls University Tübingen, University Clinic Tübingen, Tübingen, Germany: Blanca Arango-Gonzalez, Sascha Dammeier, Sigrid Diether, Sabina Honisch, Ellen Kilger, Marius Ueffing; AYOXXA Biosystems GmbH, Cologne, Germany: Tanja Endermann, Markus Zumbansen; Pro-Retina Deutschland, Aachen, Germany: Franz Badura; Department of Regeneration and Cell Therapy, Andalusian Molecular Biology and Regenerative Medicine Centre (CABIMER), Seville, Spain: Berta De la Cerda; Barcelona Macula Foundation, Barcelona, Spain: Marc Biarnés, Anna Borrell, Lucia L. Ferraro, Míriam Garcia, Jordi Monés, Eduardo Rodríguez; Department of Epidemiology, Erasmus Medical Center, Rotterdam, The Netherlands: Johanna M. Colijn, A. Ikram, Caroline C. W. Klaver, Magda Meester-Smoor, Timo Verzijden, Johannes Vingerling; Radboud University Medical Center, Nijmegen, The Netherlands: Anneke I. den Hollander, Thomas J. Heesterbeek, Caroline C. W. Klaver, Eveline Kersten, Eiko K. de Jong, I. Erkin Acar, Anita de Breuk; Centre for Experimental Medicine, Queen’s University Belfast, Belfast, United Kingdom: Eszter Emri, Imre Lengyel; Roche Innovation Center Basel, F. Hoffmann-La Roche Ltd., Basel, Switzerland: Hanno Langen, Everson Nogoceke; Centre for Public Health, Queen’s University Belfast, Belfast, United Kingdom: Tunde Peto; Institute of Ophthalmology, University College London, London, United Kingdom: Phil Luthert, Frances M. Pool., Purpose To develop a genotype assay to assess associations with common and rare age-related macular degeneration (AMD) risk variants, to calculate an overall genetic risk score (GRS), and to identify potential misdiagnoses with inherited macular dystrophies that mimic AMD. Design Case-control study. Participants Individuals (n = 4740) from 5 European cohorts. Methods We designed single-molecule molecular inversion probes for target selection and used next generation sequencing to sequence 87 single nucleotide polymorphisms (SNPs), coding and splice-site regions of 10 AMD-(related) genes (ARMS2, C3, C9, CD46, CFB, CFH, CFI, HTRA1, TIMP3, and SLC16A8), and 3 genes that cause inherited macular dystrophies (ABCA4, CTNNA1, and PRPH2). Genetic risk scores for common AMD risk variants were calculated based on effect size and genotype of 52 AMD-associated variants. Frequency of rare variants was compared between late AMD patients and control individuals with logistic regression analysis. Main Outcome Measures Genetic risk score, association of genetic variants with AMD, and genotype–phenotype correlations. Results We observed high concordance rates between our platform and other genotyping platforms for the 69 successfully genotyped SNPs (>96%) and for the rare variants (>99%). We observed a higher GRS for patients with late AMD compared with patients with early/intermediate AMD (P < 0.001) and individuals without AMD (P < 0.001). A higher proportion of pathogenic variants in the CFH (odds ratio [OR] = 2.88; P = 0.006), CFI (OR = 4.45; P = 0.005), and C3 (OR = 6.56; P = 0.0003) genes was observed in late AMD patients compared with control individuals. In 9 patients, we identified pathogenic variants in the PRPH2, ABCA4, and CTNNA1 genes, which allowed reclassification of these patients as having inherited macular dystrophy. Conclusions This study reports a genotype assay for common and rare AMD genetic variants, which can identify individuals at intermediate to high genetic risk of late AMD and enables differential diagnosis of AMD-mimicking dystrophies. Our study supports sequencing of CFH, CFI, and C3 genes because they harbor rare high-risk variants. Carriers of these variants could be amendable for new treatments for AMD that currently are under development.

Published
2020

17. T and genetic variations between Asian and Caucasian polypoidal choroidal vasculopathy

Author

Jordan-Yu, Janice Marie, primary, Teo, Kelvin, additional, Fan, Qiao, additional, Gana, Jose Carlos, additional, Leopando, Anna Karina, additional, Nunes, Sandrina, additional, Farinha, Cláudia, additional, Barreto, Patricia, additional, Melo, Joana Barbosa, additional, Carreira, Isabel, additional, Murta, Joaquim Neto, additional, Silva, Rufino, additional, and Cheung, Chui Ming Gemmy, additional

Published
2020
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19. Age-Related Macular Degeneration Staging by Color Fundus Photography vs. Multimodal Imaging—Epidemiological Implications (The Coimbra Eye Study—Report 6)

Author

Farinha, Cláudia, primary, Cachulo, Maria Luz, additional, Coimbra, Rita, additional, Alves, Dalila, additional, Nunes, Sandrina, additional, Pires, Isabel, additional, Marques, João Pedro, additional, Costa, José, additional, Martins, Amélia, additional, Sobral, Isa, additional, Barreto, Patrícia, additional, Laíns, Inês, additional, Figueira, João, additional, Ribeiro, Luisa, additional, Cunha-Vaz, José, additional, and Silva, Rufino, additional

Published
2020
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20. Efficacy and Safety of Intravitreal Aflibercept Treat and Extend for Polypoidal Choroidal Vasculopathy in the ATLANTIC Study: A Randomized Clinical Trial.

Author

Silva, Rufino, Arias, Luis, Nunes, Sandrina, Farinha, Claudia, Coimbra, Rita, Marques, João P., Cachulo, Maria L., Figueira, João, Barreto, Patricia, Madeira, Maria H., Pires, Isabel, Sousa, João C., Distefano, Laura, Rosa, Paulo, Carneiro, Ângela, Vaz-Pereira, Sara, Meireles, Angelina, Cabrera, Francisco, Bures, Anniken, and Mendonça, Luís

Subjects
POLYPOIDAL choroidal vasculopathy, CLINICAL trials, AFLIBERCEPT, INTRAVITREAL injections, ASIANS
Abstract

Importance: Polypoidal choroidal vasculopathy (PCV) is far less common and studied in a Caucasian population than in an Asian population, and the optimal treatment approach remains to be confirmed. Methods: A 52-week, double-masked, sham-controlled, phase 4, investigator-initiated randomized clinical trial (RCT) in naive symptomatic Caucasian patients with PCV treated with aflibercept in a treat-and-extend regimen (T&E) (intravitreal aflibercept injection [IVAI] T&E). Patients were randomized at week 16 to receive IVAI T&E plus either sham photodynamic therapy (PDT) or standard fluence PDT with verteporfin. The main outcome measures were changes in best-corrected visual acuity (BCVA) from baseline to 52 weeks and polyp occlusion at week 52. Data are presented as median (interquartile range [IQR]) for BCVA, number of IVAI, and change in central retinal thickness (CRT). Results: Of the 50 patients included in the study, 48 patients completed the 52 weeks of follow-up. During this period, a significant median (IQR) BCVA gain of 6 [2–12] Early Treatment Diabetic Retinopathy Study letters was observed for all patients (p < 0.001), after 8 (7–9) injections, with a significant reduction of −93.0 [−154.0, −44.0] µm in central macular thickness (p < 0.001). Using indocyanine green angiography, a complete occlusion of polypoidal lesions was documented in 72% of the cases. Still, no significant difference was detected between the sham PDT and the aflibercept PDT arms, at week 52, for BCVA change (6.5 [2–11] vs. 5 [2–13] letters (p = 0.98)), number of IVAIs (8.5 [7–9] vs. 8 [7–9] (p = 0.21)), change in CRT (−143 [−184; −47] vs. −89 [−123; −41.5] µm [p = 0.23]), and rates of complete polyp occlusion: 77 versus 68% (p = 0.53) or presence of fluid: 68 versus 57% (p = 0.56). No serious ocular adverse events were registered in the 2 arms. Conclusions and Relevance: To our knowledge, this is the first RCT to compare aflibercept T&E monotherapy with aflibercept T&E plus verteporfin PDT in a Caucasian population with PCV. Aflibercept monotherapy in a T&E showed to be effective and safe with a significant median BCVA improvement of 6 letters and a complete occlusion of polypoidal lesions in near 3 quarters of the eyes, at 1 year. As only 22% of the eyes underwent PDT treatment, the benefit of combined treatment for PCV in Caucasian patients could not be definitively elucidated from this study. Trial Registration: The clinical trial was registered in ClinicalTrials.gov Identifier NCT02495181 and the European Union Drug Regulating Authorities Clinical Trials Database EudraCT No. 2015-001368-20. [ABSTRACT FROM AUTHOR]

Published
2022
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21. Phenotypic and genetic variations between Asian and Caucasian polypoidal choroidal vasculopathy.

Author

Jordan-Yu, Janice Marie, Teo, Kelvin, Qiao Fan, Carlos Gana, Jose, Karina Leopando, Anna, Nunes, Sandrina, Farinha, Cláudia, Barreto, Patricia, Barbosa Melo, Joana, Carreira, Isabel, Murta, Joaquim Neto, Silva, Rufino, and Chui Ming Gemmy Cheung

Abstract

Purpose To compare phenotypic and genetic variations in polypoidal choroidal vasculopathy (PCV) between Caucasian and Asian patients. Methods We analysed phenotypic and genotypic data from two sites, Association for Innovation and Biomedical Research on Light and Image, Portugal and Singapore National Eye Centre, Singapore. Baseline fundus photography, spectral domain-optical coherence tomography, indocyanine green and fluorescein angiography scans were analysed by respective reading centres using a standardised grading protocol. Single nucleotide polymorphisms across 8 PCV loci were compared between cases and controls selected from each population. Results One hundred and forty treatment-naïve PCV participants (35 Portuguese and 105 Singaporean) were included. The Portuguese cohort were older (72.33±8.44 vs 68.71±9.40 years, p=0.043) and were comprised of a lower proportion of males (43% vs 71%, p=0.005) compared with the Singaporean cohort. Differences in imaging features include higher prevalence of soft drusen (66% vs 30%, p=0.004), lower prevalence of subretinal haemorrhage (14% vs 67%, p<0.001), smaller polypoidal lesion (PL) area (0.09±0.09 vs 0.76 ±0.93 mm², p<0.001), lower ratio of PL to branching vascular network area (3% vs 38%, p<0.001) and lower central retinal thickness (346.48±93.74 vs 493.16 ±212.92 µm, p<0.001) in the Portuguese cohort. CETP rs3764261 (OR 2.467; 95% CI 1.282 to 4.745, p=0.006) in the Portuguese population was significantly associated with PCV and CFH rs800292 (OR 1.719; 95% CI 1.139 to 2.596, p=0.010) in the Singaporean population, respectively. Conclusion Among Asian and Caucasian patients with PCV, there are significant differences in the expression of phenotype. We also identified different polymorphisms associated with PCV in the two populations. [ABSTRACT FROM AUTHOR]

Published
2021
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22. Increased High-Density Lipoprotein Levels Associated with Age-Related Macular Degeneration Evidence from the EYE-RISK and European Eye Epidemiology Consortia

Author

Colijn, Johanna M., den Hollander, Anneke, I, Demirkan, Ayse, Cougnard-Gregoire, Audrey, Verzijden, Timo, Kersten, Eveline, Meester-Smoor, Magda A., Merle, Benedicte M. J., Papageorgiou, Grigorios, Ahmad, Shahzad, Mulder, Monique T., Costa, Miguel Angelo, Benlian, Pascale, Bertelsen, Geir, Bron, Alain M., Claes, Birte, Creuzot-Garcher, Catherine, Erke, Maja Gran, Fauser, Sascha, Foster, Paul J., Hammond, Christopher J., Hense, Hans-Werner, Hoyng, Carel B., Khawaja, Anthony P., Korobelnik, Jean-Francois, Piermarocchi, Stefano, Segato, Tatiana, Silva, Rufino, Souied, Eric H., Williams, Katie M., van Duijn, Cornelia M., Delcourt, Cecile, Klaver, Caroline C. W., Acar, Niyazi, Altay, Lebriz, Anastosopoulos, Eleftherios, Azuara-Blanco, Augusto, Berendschot, Tos, Bergen, Arthur, Binquet, Christine, Bird, Alan, Bobak, Martin, Larsen, Morten Bogelund, Boon, Camiel, Bourne, Rupert, Bretillon, Lionel, Broe, Rebecca, Bron, Alain, Buitendijk, Gabrielle, Cachulo, Maria Luz, Capuano, Vittorio, Carriere, Isabelle, Chakravarthy, Usha, Chan, Michelle, Chang, Petrus, Colijn, Johanna, Cree, Angela, Cumberland, Phillippa, Cunha-Vaz, Jose, Daien, Vincent, De Jong, Eiko, Deak, Gabor, Delyfer, Marie-Noelle, den Hollander, Anneke, Dietzel, Martha, Faria, Pedro, Farinha, Claudia, Finger, Robert, Fletcher, Astrid, Foster, Paul, Founti, Panayiota, Gorgels, Theo, Grauslund, Jakob, Grus, Franz, Hammond, Christopher, Heesterbeek, Thomas, Hermann, Manuel, Hoehn, Rene, Hogg, Ruth, Holz, Frank, Hoyng, Carel, Jansonius, Nomdo, Janssen, Sarah, de Jonga, Eiko, Khawaja, Anthony, Klaver, Caroline, Lamparter, Julia, Le Goff, Melanie, Lehtimaki, Terho, Leung, Irene, Lotery, Andrew, Mauschitz, Matthias, Meester, Magda, Merle, Benedicte, Westrup, Verena Meyer Zu, Midena, Edoardo, Miotto, Stefania, Mirshahi, Alireza, Mohan-Said, Sadek, Mueller, Michael, Muldrew, Alyson, Murta, Joaquim, Nickels, Stefan, Nunes, Sandrina, Owen, Christopher, Peto, Tunde, Pfeiffer, Norbert, Prokofyeva, Elena, Rahi, Jugnoo, Raitakari, Olli, Rauscher, Franziska, Ribeiro, Luisa, Rougier, Marie-Benedicte, Rudnicka, Alicja, Sahel, Jose, Salonikiou, Aggeliki, Sanchez, Clarisa, Schick, Tina, Schmitz-Valckenberg, Steffen, Schuster, Alexander, Schweitzer, Cedric, Shehata, Jasmin, Silvestri, Giuliana, Simader, Christian, Souied, Eric, Speckauskas, Martynas, Springelkamp, Henriet, Tapp, Robyn, Topouzis, Fotis, van Leeuwen, Elisa, Verhoeven, Virginie, Vingerling, Hans, Von Hanno, Therese, Williams, Katie, Wolfram, Christian, Yip, Jennifer, Zerbib, Jennyfer, Ajana, Soufiane, Arango-Gonzalez, Blanca, Arndt, Verena, Bhatia, Vaibhav, Bhattacharya, Shomi S., Biarnes, Marc, Borrell, Anna, Buehren, Sebastian, Calado, Sofia M., Dammeier, Sascha, de Jong, Eiko K., De la Cerda, Berta, Diaz-Corrales, Francisco J., Diether, Sigrid, Emri, Eszter, Endermann, Tanja, Ferraro, Lucia L., Garcia, Miriam, Heesterbeek, Thomas J., Honisch, Sabina, Kilger, Ellen, Langen, Hanno, Lengyel, Imre, Luthert, Phil, Maugeais, Cyrille, Meester-Smoor, Magda, Inserm, Benedicte M. J. Merle, Mones, Jordi, Nogoceke, Everson, Pool, Frances M., Rodriguez, Eduardo, Ueffing, Marius, Bartz-Schmidt, Karl U. Ulrich, van Leeuwen, Elisabeth M., Zumbansen, Markus, Colijn, Johanna M., den Hollander, Anneke, I, Demirkan, Ayse, Cougnard-Gregoire, Audrey, Verzijden, Timo, Kersten, Eveline, Meester-Smoor, Magda A., Merle, Benedicte M. J., Papageorgiou, Grigorios, Ahmad, Shahzad, Mulder, Monique T., Costa, Miguel Angelo, Benlian, Pascale, Bertelsen, Geir, Bron, Alain M., Claes, Birte, Creuzot-Garcher, Catherine, Erke, Maja Gran, Fauser, Sascha, Foster, Paul J., Hammond, Christopher J., Hense, Hans-Werner, Hoyng, Carel B., Khawaja, Anthony P., Korobelnik, Jean-Francois, Piermarocchi, Stefano, Segato, Tatiana, Silva, Rufino, Souied, Eric H., Williams, Katie M., van Duijn, Cornelia M., Delcourt, Cecile, Klaver, Caroline C. W., Acar, Niyazi, Altay, Lebriz, Anastosopoulos, Eleftherios, Azuara-Blanco, Augusto, Berendschot, Tos, Bergen, Arthur, Binquet, Christine, Bird, Alan, Bobak, Martin, Larsen, Morten Bogelund, Boon, Camiel, Bourne, Rupert, Bretillon, Lionel, Broe, Rebecca, Bron, Alain, Buitendijk, Gabrielle, Cachulo, Maria Luz, Capuano, Vittorio, Carriere, Isabelle, Chakravarthy, Usha, Chan, Michelle, Chang, Petrus, Colijn, Johanna, Cree, Angela, Cumberland, Phillippa, Cunha-Vaz, Jose, Daien, Vincent, De Jong, Eiko, Deak, Gabor, Delyfer, Marie-Noelle, den Hollander, Anneke, Dietzel, Martha, Faria, Pedro, Farinha, Claudia, Finger, Robert, Fletcher, Astrid, Foster, Paul, Founti, Panayiota, Gorgels, Theo, Grauslund, Jakob, Grus, Franz, Hammond, Christopher, Heesterbeek, Thomas, Hermann, Manuel, Hoehn, Rene, Hogg, Ruth, Holz, Frank, Hoyng, Carel, Jansonius, Nomdo, Janssen, Sarah, de Jonga, Eiko, Khawaja, Anthony, Klaver, Caroline, Lamparter, Julia, Le Goff, Melanie, Lehtimaki, Terho, Leung, Irene, Lotery, Andrew, Mauschitz, Matthias, Meester, Magda, Merle, Benedicte, Westrup, Verena Meyer Zu, Midena, Edoardo, Miotto, Stefania, Mirshahi, Alireza, Mohan-Said, Sadek, Mueller, Michael, Muldrew, Alyson, Murta, Joaquim, Nickels, Stefan, Nunes, Sandrina, Owen, Christopher, Peto, Tunde, Pfeiffer, Norbert, Prokofyeva, Elena, Rahi, Jugnoo, Raitakari, Olli, Rauscher, Franziska, Ribeiro, Luisa, Rougier, Marie-Benedicte, Rudnicka, Alicja, Sahel, Jose, Salonikiou, Aggeliki, Sanchez, Clarisa, Schick, Tina, Schmitz-Valckenberg, Steffen, Schuster, Alexander, Schweitzer, Cedric, Shehata, Jasmin, Silvestri, Giuliana, Simader, Christian, Souied, Eric, Speckauskas, Martynas, Springelkamp, Henriet, Tapp, Robyn, Topouzis, Fotis, van Leeuwen, Elisa, Verhoeven, Virginie, Vingerling, Hans, Von Hanno, Therese, Williams, Katie, Wolfram, Christian, Yip, Jennifer, Zerbib, Jennyfer, Ajana, Soufiane, Arango-Gonzalez, Blanca, Arndt, Verena, Bhatia, Vaibhav, Bhattacharya, Shomi S., Biarnes, Marc, Borrell, Anna, Buehren, Sebastian, Calado, Sofia M., Dammeier, Sascha, de Jong, Eiko K., De la Cerda, Berta, Diaz-Corrales, Francisco J., Diether, Sigrid, Emri, Eszter, Endermann, Tanja, Ferraro, Lucia L., Garcia, Miriam, Heesterbeek, Thomas J., Honisch, Sabina, Kilger, Ellen, Langen, Hanno, Lengyel, Imre, Luthert, Phil, Maugeais, Cyrille, Meester-Smoor, Magda, Inserm, Benedicte M. J. Merle, Mones, Jordi, Nogoceke, Everson, Pool, Frances M., Rodriguez, Eduardo, Ueffing, Marius, Bartz-Schmidt, Karl U. Ulrich, van Leeuwen, Elisabeth M., and Zumbansen, Markus

Abstract

Purpose: Genetic and epidemiologic studies have shown that lipid genes and high-density lipoproteins (HDLs) are implicated in age-related macular degeneration (AMD). We studied circulating lipid levels in relationship to AMD in a large European dataset. Design: Pooled analysis of cross-sectional data. Participants: Individuals (N = 30 953) aged 50 years or older participating in the European Eye Epidemiology (E3) consortium and 1530 individuals from the Rotterdam Study with lipid subfraction data. Methods: AMD features were graded on fundus photographs using the Rotterdam classification. Routine blood lipid measurements, genetics, medication, and potential confounders were extracted from the E3 database. In a subgroup of the Rotterdam Study, lipid subfractions were identified by the Nightingale biomarker platform. Random-intercepts mixed-effects models incorporating confounders and study site as a random effect were used to estimate associations. Main Outcome Measures: AMD features and stage; lipid measurements. Results: HDL was associated with an increased risk of AMD (odds ratio [OR], 1.21 per 1-mmol/l increase; 95% confidence interval [CI], 1.14-1.29), whereas triglycerides were associated with a decreased risk (OR, 0.94 per 1-mmol/l increase; 95% CI, 0.91-0.97). Both were associated with drusen size. Higher HDL raised the odds of larger drusen, whereas higher triglycerides decreases the odds. LDL cholesterol reached statistical significance only in the association with early AMD (P = 0.045). Regarding lipid subfractions, the concentration of extra-large HDL particles showed the most prominent association with AMD (OR, 1.24; 95% CI, 1.10-1.40). The cholesteryl ester transfer protein risk variant (rs17231506) for AMD was in line with increased HDL levels (P = 7.7 x 10(-7)), but lipase C risk variants (rs2043085, rs2070895) were associated in an opposite way (P = 1.0 x 10(-6) and P = 1.6 x 10(-4)). Conclusions: Our study suggested that HDL cholesterol is associated

Published
2019

23. The European Eye Epidemiology spectral-domain optical coherence tomography classification of macular diseases for epidemiological studies

Author

Gattoussi, Sarra, Buitendijk, Gabrielle H. S., Peto, Tunde, Leung, Irene, Schmitz-Valckenberg, Steffen, Oishi, Akio, Wolf, Sebastian, Deak, Gabor, Delcourt, Ccile, Klaver, Caroline C. W., Korobelnik, Jean-Fracnois, Acar, Niyazi, Anas-Tosopoulos, Eleftherios, Azuara-Blanco, Augusto, Berendschot, Tos, Bertelsen, Geir, Binquet, Christine, Bird, Alan, Bobak, Martin, Larsen, Morten Bogelund, Boon, Camiel, Bourne, Rupert, Bretillon, Lionel, Broe, Rebecca, Bron, Alain, Buitendijk, Gabrielle, Cachulo, Maria Luz, Capuano, Vittorio, Carriere, Isabelle, Chakravarthy, Usha, Chan, Michelle, Chang, Petrus, Colijn, Johanna, Cree, Angela, Creuzot-Garcher, Catherine, Cumberland, Phillippa, Cunha-Vaz, Jose, Daien, Vincent, De Jong, Eiko, Delcourt, Cecile, Delyfer, Marie-Noelle, den Hollan-Der, Anneke, Dietzel, Martha, Erke, Maja Gran, Faria, Pedro, Farinha, Claudia, Fauser, Sascha, Finger, Robert, Fletcher, Astrid, Foster, Paul, Found, Panayiota, Gorgels, Theo, Grauslund, Jakob, Grus, Franz, Hammond, Christopher, Helmer, Catherine, Hense, Hans-Werner, Hermann, Manuel, Hoehn, Rene, Hogg, Ruth, Holz, Frank, Hoyng, Carel, Jansonius, Nomdo, Janssen, Sarah, Kersten, Eveline, Khawaja, Anthony, Klaver, Caroline, Korobelnik, Jean-Francois, Lamparter, Julia, Le Goff, Melanie, Lechanteur, Yara, Lehtimaki, Terho, Lotery, Andrew, Mauschitz, Matthias, Meester, Magda, Merle, Benedicte, zu Westrup, Verena Meyer, Midena, Edoardo, Miotto, Stefania, Mirshahi, Alireza, Mohan-Said, Sadek, Muldrew, Alyson, Murta, Joaquim, Nickels, Stefan, Nunes, Sandrina, Pfeiffer, Norbert, Piermarocchi, Stefano, Prokofyeva, Elena, Rahi, Jugnoo, Raitakari, Olli, Rauscher, Franziska, Ribeiro, Luisa, Rougier, Marie-Benedicte, Rudnicka, Alicja, Sahel, Jose, Salonikiou, Aggeliki, Sanchez, Clarisa, Schuster, Alexander, Schweitzer, Cedric, Segato, Tatiana, Shehata, Jasmin, Silva, Rutino, Silvestri, Giuliana, Souied, Eric, Speckauskas, Martynas, Springelkamp, Henriet, Tapp, Robyn, Topouzis, Fotis, van Leeuwen, Elisa, Verhoeven, Virginie, Verzijden, Timo, Von Hanno, Therese, Wiedemann, Peter, Williams, Katie, Wolfram, Christian, Yip, Jennifer, Zerbib, Jennyfer, Gattoussi, Sarra, Buitendijk, Gabrielle H. S., Peto, Tunde, Leung, Irene, Schmitz-Valckenberg, Steffen, Oishi, Akio, Wolf, Sebastian, Deak, Gabor, Delcourt, Ccile, Klaver, Caroline C. W., Korobelnik, Jean-Fracnois, Acar, Niyazi, Anas-Tosopoulos, Eleftherios, Azuara-Blanco, Augusto, Berendschot, Tos, Bertelsen, Geir, Binquet, Christine, Bird, Alan, Bobak, Martin, Larsen, Morten Bogelund, Boon, Camiel, Bourne, Rupert, Bretillon, Lionel, Broe, Rebecca, Bron, Alain, Buitendijk, Gabrielle, Cachulo, Maria Luz, Capuano, Vittorio, Carriere, Isabelle, Chakravarthy, Usha, Chan, Michelle, Chang, Petrus, Colijn, Johanna, Cree, Angela, Creuzot-Garcher, Catherine, Cumberland, Phillippa, Cunha-Vaz, Jose, Daien, Vincent, De Jong, Eiko, Delcourt, Cecile, Delyfer, Marie-Noelle, den Hollan-Der, Anneke, Dietzel, Martha, Erke, Maja Gran, Faria, Pedro, Farinha, Claudia, Fauser, Sascha, Finger, Robert, Fletcher, Astrid, Foster, Paul, Found, Panayiota, Gorgels, Theo, Grauslund, Jakob, Grus, Franz, Hammond, Christopher, Helmer, Catherine, Hense, Hans-Werner, Hermann, Manuel, Hoehn, Rene, Hogg, Ruth, Holz, Frank, Hoyng, Carel, Jansonius, Nomdo, Janssen, Sarah, Kersten, Eveline, Khawaja, Anthony, Klaver, Caroline, Korobelnik, Jean-Francois, Lamparter, Julia, Le Goff, Melanie, Lechanteur, Yara, Lehtimaki, Terho, Lotery, Andrew, Mauschitz, Matthias, Meester, Magda, Merle, Benedicte, zu Westrup, Verena Meyer, Midena, Edoardo, Miotto, Stefania, Mirshahi, Alireza, Mohan-Said, Sadek, Muldrew, Alyson, Murta, Joaquim, Nickels, Stefan, Nunes, Sandrina, Pfeiffer, Norbert, Piermarocchi, Stefano, Prokofyeva, Elena, Rahi, Jugnoo, Raitakari, Olli, Rauscher, Franziska, Ribeiro, Luisa, Rougier, Marie-Benedicte, Rudnicka, Alicja, Sahel, Jose, Salonikiou, Aggeliki, Sanchez, Clarisa, Schuster, Alexander, Schweitzer, Cedric, Segato, Tatiana, Shehata, Jasmin, Silva, Rutino, Silvestri, Giuliana, Souied, Eric, Speckauskas, Martynas, Springelkamp, Henriet, Tapp, Robyn, Topouzis, Fotis, van Leeuwen, Elisa, Verhoeven, Virginie, Verzijden, Timo, Von Hanno, Therese, Wiedemann, Peter, Williams, Katie, Wolfram, Christian, Yip, Jennifer, and Zerbib, Jennyfer

Abstract

Purpose The aim of the European Eye Epidemiology (E3) consortium was to develop a spectral-domain optical coherence tomography (SD-OCT)-based classification for macular diseases to standardize epidemiological studies. Methods A European panel of vitreoretinal disease experts and epidemiologists belonging to the E3 consortium was assembled to define a classification for SD-OCT imaging of the macula. A series of meeting was organized, to develop, test and finalize the classification. First, grading methods used by the different research groups were presented and discussed, and a first version of classification was proposed. This first version was then tested on a set of 50 SD-OCT images in the Bordeaux and Rotterdam centres. Agreements were analysed and discussed with the panel of experts and a final version of the classification was produced. Results Definitions and classifications are proposed for the structure assessment of the vitreomacular interface (visibility of vitreous interface, vitreomacular adhesion, vitreomacular traction, epiretinal membrane, full-thickness macular hole, lamellar macular hole, macular pseudo-hole) and of the retina (retinoschisis, drusen, pigment epithelium detachment, hyper-reflective clumps, retinal pigment epithelium atrophy, intraretinal cystoid spaces, intraretinal tubular changes, subretinal fluid, subretinal material). Classifications according to size and location are defined. Illustrations of each item are provided, as well as the grading form. Conclusion The E3 SD-OCT classification has been developed to harmonize epidemiological studies. This homogenization will allow comparing and sharing data collection between European and international studies.

Published
2019

24. Validation of RetmarkerAMD as a semiautomatic grading software for AMD

Author

Marques, João Pedro, primary, Pires, João, additional, Simão, Jorge, additional, Marques, Marco, additional, Gil, João Q., additional, Laíns, Inês, additional, Alves, Dalila, additional, Nunes, Sandrina, additional, Cachulo, Maria Luz, additional, Miller, John B., additional, Vavvas, Demetrios G., additional, Miller, Joan W., additional, Husain, Deeba, additional, and Silva, Rufino, additional

Published
2019
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25. Increased High-Density Lipoprotein Levels Associated with Age-Related Macular Degeneration

Author

Colijn, Johanna M., primary, den Hollander, Anneke I., additional, Demirkan, Ayse, additional, Cougnard-Grégoire, Audrey, additional, Verzijden, Timo, additional, Kersten, Eveline, additional, Meester-Smoor, Magda A., additional, Merle, Benedicte M.J., additional, Papageorgiou, Grigorios, additional, Ahmad, Shahzad, additional, Mulder, Monique T., additional, Costa, Miguel Angelo, additional, Benlian, Pascale, additional, Bertelsen, Geir, additional, Bron, Alain M., additional, Claes, Birte, additional, Creuzot-Garcher, Catherine, additional, Erke, Maja Gran, additional, Fauser, Sascha, additional, Foster, Paul J., additional, Hammond, Christopher J., additional, Hense, Hans-Werner, additional, Hoyng, Carel B., additional, Khawaja, Anthony P., additional, Korobelnik, Jean-Francois, additional, Piermarocchi, Stefano, additional, Segato, Tatiana, additional, Silva, Rufino, additional, Souied, Eric H., additional, Williams, Katie M., additional, van Duijn, Cornelia M., additional, Delcourt, Cécile, additional, Klaver, Caroline C.W., additional, Acar, Niyazi, additional, Altay, Lebriz, additional, Anastosopoulos, Eleftherios, additional, Azuara-Blanco, Augusto, additional, Berendschot, Tos, additional, Bergen, Arthur, additional, Binquet, Christine, additional, Bird, Alan, additional, Bobak, Martin, additional, Larsen, Morten Bøgelund, additional, Boon, Camiel, additional, Bourne, Rupert, additional, Brétillon, Lionel, additional, Broe, Rebecca, additional, Bron, Alain, additional, Buitendijk, Gabrielle, additional, Cachulo, Maria Luz, additional, Capuano, Vittorio, additional, Carrière, Isabelle, additional, Chakravarthy, Usha, additional, Chan, Michelle, additional, Chang, Petrus, additional, Colijn, Johanna, additional, Cree, Angela, additional, Cumberland, Phillippa, additional, Cunha-Vaz, José, additional, Daien, Vincent, additional, De Jong, Eiko, additional, Deak, Gabor, additional, Delyfer, Marie-Noëlle, additional, Hollander, Anneke den, additional, Dietzel, Martha, additional, Faria, Pedro, additional, Farinha, Claudia, additional, Finger, Robert, additional, Fletcher, Astrid, additional, Foster, Paul, additional, Founti, Panayiota, additional, Gorgels, Theo, additional, Grauslund, Jakob, additional, Grus, Franz, additional, Hammond, Christopher, additional, Heesterbeek, Thomas, additional, Hermann, Manuel, additional, Hoehn, René, additional, Hogg, Ruth, additional, Holz, Frank, additional, Hoyng, Carel, additional, Jansonius, Nomdo, additional, Janssen, Sarah, additional, de Jong, Eiko, additional, Khawaja, Anthony, additional, Klaver, Caroline, additional, Korobelnik, Jean-François, additional, Lamparter, Julia, additional, Le Goff, Mélanie, additional, Lehtimäki, Terho, additional, Leung, Irene, additional, Lotery, Andrew, additional, Mauschitz, Matthias, additional, Meester, Magda, additional, Merle, Bénédicte, additional, Meyer zu Westrup, Verena, additional, Midena, Edoardo, additional, Miotto, Stefania, additional, Mirshahi, Alireza, additional, Mohan-Saïd, Sadek, additional, Mueller, Michael, additional, Muldrew, Alyson, additional, Murta, Joaquim, additional, Nickels, Stefan, additional, Nunes, Sandrina, additional, Owen, Christopher, additional, Peto, Tunde, additional, Pfeiffer, Norbert, additional, Prokofyeva, Elena, additional, Rahi, Jugnoo, additional, Raitakari, Olli, additional, Rauscher, Franziska, additional, Ribeiro, Luisa, additional, Rougier, Marie-Bénédicte, additional, Rudnicka, Alicja, additional, Sahel, José, additional, Salonikiou, Aggeliki, additional, Sanchez, Clarisa, additional, Schick, Tina, additional, Schmitz-Valckenberg, Steffen, additional, Schuster, Alexander, additional, Schweitzer, Cédric, additional, Shehata, Jasmin, additional, Silvestri, Giuliana, additional, Simader, Christian, additional, Souied, Eric, additional, Speckauskas, Martynas, additional, Springelkamp, Henriet, additional, Tapp, Robyn, additional, Topouzis, Fotis, additional, van Leeuwen, Elisa, additional, Verhoeven, Virginie, additional, Vingerling, Hans, additional, Von Hanno, Therese, additional, Williams, Katie, additional, Wolfram, Christian, additional, Yip, Jennifer, additional, Zerbib, Jennyfer, additional, Ajana, Soufiane, additional, Arango-Gonzalez, Blanca, additional, Arndt, Verena, additional, Bhatia, Vaibhav, additional, Bhattacharya, Shomi S., additional, Biarnés, Marc, additional, Borrell, Anna, additional, Bühren, Sebastian, additional, Calado, Sofia M., additional, Colijn, Johanna M., additional, Dammeier, Sascha, additional, de Jong, Eiko K., additional, De la Cerda, Berta, additional, Diaz-Corrales, Francisco J., additional, Diether, Sigrid, additional, Emri, Eszter, additional, Endermann, Tanja, additional, Ferraro, Lucia L., additional, Garcia, Míriam, additional, Heesterbeek, Thomas J., additional, Honisch, Sabina, additional, Kilger, Ellen, additional, Langen, Hanno, additional, Lengyel, Imre, additional, Luthert, Phil, additional, Maugeais, Cyrille, additional, Meester-Smoor, Magda, additional, Merle Inserm, Bénédicte M.J., additional, Monés, Jordi, additional, Nogoceke, Everson, additional, Pool, Frances M., additional, Rodríguez, Eduardo, additional, Ueffing, Marius, additional, Ulrich Bartz-Schmidt, Karl U., additional, van Leeuwen, Elisabeth M., additional, and Zumbansen, Markus, additional

Published
2019
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26. Incidence of Age-Related Macular Degeneration in the Central Region of Portugal: The Coimbra Eye Study – Report 5

Author

Farinha, Cláudia Virgínia Louro, primary, Cachulo, Maria Luz, additional, Alves, Dalila, additional, Pires, Isabel, additional, Marques, João Pedro, additional, Barreto, Patrícia, additional, Nunes, Sandrina, additional, Costa, José, additional, Martins, Amélia, additional, Sobral, Isa, additional, Laíns, Inês, additional, Figueira, João, additional, Ribeiro, Luísa, additional, Cunha-Vaz, José, additional, and Silva, Rufino, additional

Published
2019
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27. Systemic and Ocular Determinants of Peripapillary Retinal Nerve Fiber Layer Thickness Measurements in the European Eye Epidemiology (E3) Population

Author

Mauschitz, Matthias M., Mauschitz, Matthias M., Bonnemaijer, Pieter W. M., Diers, Kersten, Rauscher, Franziska G., Elze, Tobias, Engel, Christoph, Loeffler, Markus, Colijn, Johanna Maria, Ikram, M. Arfan, Vingerling, Johannes R., Williams, Katie M., Hammond, Christopher J., Creuzot-Garcher, Catherine, Bron, Alain M., Silva, Rufino, Nunes, Sandrina, Delcourt, Cecile, Cougnard-Gregoire, Audrey, Holz, Frank G., Klaver, Caroline C. W., Breteler, Monique M. B., Finger, Robert P., European Eye Epidemiology E3, Berendschot, Tos, Mauschitz, Matthias M., Mauschitz, Matthias M., Bonnemaijer, Pieter W. M., Diers, Kersten, Rauscher, Franziska G., Elze, Tobias, Engel, Christoph, Loeffler, Markus, Colijn, Johanna Maria, Ikram, M. Arfan, Vingerling, Johannes R., Williams, Katie M., Hammond, Christopher J., Creuzot-Garcher, Catherine, Bron, Alain M., Silva, Rufino, Nunes, Sandrina, Delcourt, Cecile, Cougnard-Gregoire, Audrey, Holz, Frank G., Klaver, Caroline C. W., Breteler, Monique M. B., Finger, Robert P., European Eye Epidemiology E3, and Berendschot, Tos

Abstract

Purpose: To investigate systemic and ocular determinants of peripapillary retinal nerve fiber layer thickness (pRNFLT) in the European population.Design: Cross-sectional meta-analysis.Participants: A total of 16 084 European adults from 8 cohort studies (mean age range, 56.9 +/- 12.3-82.1 +/- 4.2 years) of the European Eye Epidemiology (E3) consortium.Methods: We examined associations with pRNFLT measured by spectral-domain OCT in each study using multivariable linear regression and pooled results using random effects meta-analysis.Main Outcome Measures: Determinants of pRNFLT.Results: Mean pRNFLT ranged from 86.8 +/- 21.4 mu m in the Rotterdam Study I to 104.7 +/- 12.5 mu m in the Rotterdam Study III. We found the following factors to be associated with reduced pRNFLT: Older age (beta = -0.38 mu m/year; 95% confidence interval [CI], -0.57 to -0.18), higher intraocular pressure (10P) (beta = -0.36 mu m/mmHg; 95% CI, -0.56 to -0.15), visual impairment (beta = -5.50 mu m; 95% CI, -9.37 to -1.64), and history of systemic hypertension (beta = -0.54 mu m; 95% CI, -1.01 to -0.07) and stroke (beta = -1.94 mu m; 95% CI, -3.17 to -0.72). A suggestive, albeit nonsignificant, association was observed for dementia (beta = -3.11 mu m; 95% CI, -6.22 to 0.01). Higher pRNFLT was associated with more hyperopic spherical equivalent (beta = 1.39 mu m/diopter; 95% CI, 1.19-1.59) and smoking (beta = 1.53 mu m; 95% CI, 1.00-2.06 for current smokers compared with never-smokers).Conclusions: In addition to previously described determinants such as age and refraction, we found that systemic vascular and neurovascular diseases were associated with reduced pRNFLT. These may be of clinical relevance, especially in glaucoma monitoring of patients with newly occurring vascular comorbidities. (C) 2018 by the American Academy of Ophthalmology

Published
2018

28. Systemic and Ocular Determinants of Peripapillary Retinal Nerve Fiber Layer Thickness Measurements in the European Eye Epidemiology (E3) Population

Author

Mauschitz, Matthias M., primary, Bonnemaijer, Pieter W.M., additional, Diers, Kersten, additional, Rauscher, Franziska G., additional, Elze, Tobias, additional, Engel, Christoph, additional, Loeffler, Markus, additional, Colijn, Johanna Maria, additional, Ikram, M. Arfan, additional, Vingerling, Johannes R., additional, Williams, Katie M., additional, Hammond, Christopher J., additional, Creuzot-Garcher, Catherine, additional, Bron, Alain M., additional, Silva, Rufino, additional, Nunes, Sandrina, additional, Delcourt, Cécile, additional, Cougnard-Grégoire, Audrey, additional, Holz, Frank G., additional, Klaver, Caroline C.W., additional, Breteler, Monique M.B., additional, Finger, Robert P., additional, Acar, Niyazi, additional, Anastosopoulos, Eleftherios, additional, Azuara-Blanco, Augusto, additional, Berendschot, Tos, additional, Bergen, Arthur, additional, Bertelsen, Geir, additional, Binquet, Christine, additional, Bird, Alan, additional, Bobak, Martin, additional, Larsen, Morten Bøgelund, additional, Boon, Camiel, additional, Bourne, Rupert, additional, Brétillon, Lionel, additional, Broe, Rebecca, additional, Bron, Alain, additional, Buitendijk, Gabrielle, additional, Cachulo, Maria Luz, additional, Capuano, Vittorio, additional, Carrière, Isabelle, additional, Chakravarthy, Usha, additional, Chan, Michelle, additional, Chang, Petrus, additional, Colijn, Johanna, additional, Cree, Angela, additional, Cumberland, Phillippa, additional, Cunha-Vaz, José, additional, Daien, Vincent, additional, De Jong, Eiko, additional, Deak, Gabor, additional, Delyfer, Marie-Noëlle, additional, Hollander, Anneke den, additional, Dietzel, Martha, additional, Erke, Maja Gran, additional, Faria, Pedro, additional, Farinha, Claudia, additional, Fauser, Sascha, additional, Finger, Robert, additional, Fletcher, Astrid, additional, Foster, Paul, additional, Founti, Panayiota, additional, Gorgels, Theo, additional, Grauslund, Jakob, additional, Grus, Franz, additional, Hammond, Christopher, additional, Hense, Hans-Werner, additional, Hermann, Manuel, additional, Hoehn, René, additional, Hogg, Ruth, additional, Holz, Frank, additional, Hoyng, Carel, additional, Jansonius, Nomdo, additional, Janssen, Sarah, additional, Kersten, Eveline, additional, Khawaja, Anthony, additional, Klaver, Caroline, additional, Korobelnik, Jean-François, additional, Lamparter, Julia, additional, Le Goff, Mélanie, additional, Lechanteur, Yara, additional, Lehtimäki, Terho, additional, Leung, Irene, additional, Lotery, Andrew, additional, Mauschitz, Matthias, additional, Meester, Magda, additional, Merle, Bénédicte, additional, Meyer zu Westrup, Verena, additional, Midena, Edoardo, additional, Miotto, Stefania, additional, Mirshahi, Alireza, additional, Mohan-Saïd, Sadek, additional, Mueller, Michael, additional, Muldrew, Alyson, additional, Murta, Joaquim, additional, Nickels, Stefan, additional, Owen, Christopher, additional, Peto, Tunde, additional, Pfeiffer, Norbert, additional, Piermarocchi, Stefano, additional, Prokofyeva, Elena, additional, Rahi, Jugnoo, additional, Raitakari, Olli, additional, Rauscher, Franziska, additional, Ribeiro, Luisa, additional, Rougier, Marie-Bénédicte, additional, Rudnicka, Alicja, additional, Sahel, José, additional, Salonikiou, Aggeliki, additional, Sanchez, Clarisa, additional, Schmitz-Valckenberg, Steffen, additional, Schuster, Alexander, additional, Schweitzer, Cédric, additional, Segato, Tatiana, additional, Shehata, Jasmin, additional, Silvestri, Giuliana, additional, Simader, Christian, additional, Souied, Eric, additional, Speckauskas, Martynas, additional, Springelkamp, Henriet, additional, Tapp, Robyn, additional, Topouzis, Fotis, additional, van Leeuwen, Elisa, additional, Verhoeven, Virginie, additional, Verzijden, Timo, additional, Von Hanno, Therese, additional, Wiedemann, Peter, additional, Williams, Katie, additional, Wolfram, Christian, additional, Yip, Jennifer, additional, and Zerbib, Jennyfer, additional

Published
2018
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29. Adherence to a Mediterranean diet, lifestyle and age-related macular degeneration: the Coimbra Eye Study - report 3

Author

Raimundo, Miguel, primary, Mira, Filipe, additional, Cachulo, Maria da Luz, additional, Barreto, Patrícia, additional, Ribeiro, Luísa, additional, Farinha, Cláudia, additional, Laíns, Inês, additional, Nunes, Sandrina, additional, Alves, Dalila, additional, Figueira, João, additional, Merle, Bénédicte MJ, additional, Delcourt, Cécile, additional, Santos, Lèlita, additional, and Silva, Rufino, additional

Published
2018
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30. The Decreasing Prevalence of Nonrefractive Visual Impairment in Older Europeans

Author

Delcourt, Cécile, primary, Le Goff, Mélanie, additional, von Hanno, Therese, additional, Mirshahi, Alireza, additional, Khawaja, Anthony P., additional, Verhoeven, Virginie J.M., additional, Hogg, Ruth E., additional, Anastosopoulos, Eleftherios, additional, Cachulo, Maria Luz, additional, Höhn, René, additional, Wolfram, Christian, additional, Bron, Alain, additional, Miotto, Stefania, additional, Carrière, Isabelle, additional, Colijn, Johanna M., additional, Buitendijk, Gabriëlle H.S., additional, Evans, Jennifer, additional, Nitsch, Dorothea, additional, Founti, Panayiota, additional, Yip, Jennifer L.Y., additional, Pfeiffer, Norbert, additional, Creuzot-Garcher, Catherine, additional, Silva, Rufino, additional, Piermarocchi, Stefano, additional, Topouzis, Fotis, additional, Bertelsen, Geir, additional, Foster, Paul J., additional, Fletcher, Astrid, additional, Klaver, Caroline C.W., additional, Korobelnik, Jean-François, additional, Acar, Niyazi, additional, Azuara-Blanco, Augusto, additional, Berendschot, Tos, additional, Bergen, Arthur, additional, Binquet, Christine, additional, Bird, Alan, additional, Bobak, Martin, additional, Boon, Camiel, additional, Brétillon, Lionel, additional, Broe, Rebecca, additional, Buitendijk, Gabrielle, additional, Capuano, Vittorio, additional, Chakravarthy, Usha, additional, Chan, Michelle, additional, Chang, Petrus, additional, Colijn, Johanna, additional, Cougnard-Grégoire, Audrey, additional, Cree, Angela, additional, Cumberland, Phillippa, additional, Cunha-Vaz, José, additional, Daien, Vincent, additional, De Jong, Eiko, additional, Deak, Gabor, additional, Delcourt, Cécile, additional, Delyfer, Marie-Noëlle, additional, den Hollander, Anneke, additional, Dietzel, Martha, additional, Erke, Maja Gran, additional, Faria, Pedro, additional, Farinha, Claudia, additional, Fauser, Sascha, additional, Finger, Robert, additional, Foster, Paul, additional, Gorgels, Theo, additional, Grauslund, Jakob, additional, Grus, Franz, additional, Hammond, Christopher, additional, Hansen, Morten, additional, Helmer, Catherine, additional, Hense, Hans-Werner, additional, Hermann, Manuel, additional, Hoehn, René, additional, Hogg, Ruth, additional, Holz, Frank, additional, Hoyng, Carel, additional, Jansonius, Nomdo, additional, Janssen, Sarah, additional, Kersten, Eveline, additional, Khawaja, Anthony, additional, Klaver, Caroline, additional, Lamparter, Julia, additional, Lechanteur, Yara, additional, Lehtimäki, Terho, additional, Leung, Irene, additional, Lotery, Andrew, additional, Mauschitz, Matthias, additional, Meester, Magda, additional, Merle, Bénédicte, additional, Meyer zu Westrup, Verena, additional, Midena, Edoardo, additional, Mohan-Saïd, Sadek, additional, Mueller, Michael, additional, Muldrew, Alyson, additional, Murta, Joaquim, additional, Nickels, Stefan, additional, Nunes, Sandrina, additional, Owen, Christopher, additional, Peto, Tunde, additional, Prokofyeva, Elena, additional, Rahi, Jugnoo, additional, Raitakari, Olli, additional, Rauscher, Franziska, additional, Ribeiro, Luisa, additional, Rougier, Marie-Bénédicte, additional, Rudnicka, Alicja, additional, Sahel, José, additional, Salonikiou, Aggeliki, additional, Sanchez, Clarisa, additional, Schmitz-Valckenberg, Steffen, additional, Schouten, Johannes, additional, Schuster, Alexander, additional, Schweitzer, Cédric, additional, Segato, Tatiana, additional, Shehata, Jasmin, additional, Silvestri, Giuliana, additional, Simader, Christian, additional, Souied, Eric, additional, Speckauskas, Martynas, additional, Springelkamp, Henriet, additional, Tapp, Robyn, additional, van Leeuwen, Elisa, additional, Verhoeven, Virginie, additional, Verzijden, Timo, additional, Von Hanno, Therese, additional, Vujosevic, Stela, additional, Wiedemann, Peter, additional, Williams, Katie, additional, Yip, Jennifer, additional, and Zerbib, Jennyfer, additional

Published
2018
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31. Ranibizumab Plus Panretinal Photocoagulation versus Panretinal Photocoagulation Alone for High-Risk Proliferative Diabetic Retinopathy (PROTEUS Study)

Author

Figueira, João, primary, Fletcher, Emily, additional, Massin, Pascale, additional, Silva, Rufino, additional, Bandello, Francesco, additional, Midena, Edoardo, additional, Varano, Monica, additional, Sivaprasad, Sobha, additional, Eleftheriadis, Haralabos, additional, Menon, Geeta, additional, Amaro, Miguel, additional, Ayello Scheer, Sarah, additional, Creuzot-Garcher, Catherine, additional, Nascimento, João, additional, Alves, Dalila, additional, Nunes, Sandrina, additional, Lobo, Conceição, additional, and Cunha-Vaz, José, additional

Published
2018
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32. Prevalence of Age-Related Macular Degeneration in Europe

Author

Colijn, Johanna M., primary, Buitendijk, Gabriëlle H.S., additional, Prokofyeva, Elena, additional, Alves, Dalila, additional, Cachulo, Maria L., additional, Khawaja, Anthony P., additional, Cougnard-Gregoire, Audrey, additional, Merle, Bénédicte M.J., additional, Korb, Christina, additional, Erke, Maja G., additional, Bron, Alain, additional, Anastasopoulos, Eleftherios, additional, Meester-Smoor, Magda A., additional, Segato, Tatiana, additional, Piermarocchi, Stefano, additional, de Jong, Paulus T.V.M., additional, Vingerling, Johannes R., additional, Topouzis, Fotis, additional, Creuzot-Garcher, Catherine, additional, Bertelsen, Geir, additional, Pfeiffer, Norbert, additional, Fletcher, Astrid E., additional, Foster, Paul J., additional, Silva, Rufino, additional, Korobelnik, Jean-François, additional, Delcourt, Cécile, additional, Klaver, Caroline C.W., additional, Ajana, Soufiane, additional, Arango-Gonzalez, Blanca, additional, Arndt, Verena, additional, Bhatia, Vaibhav, additional, Bhattacharya, Shomi S., additional, Biarnés, Marc, additional, Borrell, Anna, additional, Bühren, Sebastian, additional, Calado, Sofia M., additional, Colijn, Johanna M., additional, Cougnard-Grégoire, Audrey, additional, Dammeier, Sascha, additional, de Jong, Eiko K., additional, De la Cerda, Berta, additional, den Hollander, Anneke I., additional, Diaz-Corrales, Francisco J., additional, Diether, Sigrid, additional, Emri, Eszter, additional, Endermann, Tanja, additional, Ferraro, Lucia L., additional, Garcia, Míriam, additional, Heesterbeek, Thomas J., additional, Honisch, Sabina, additional, Hoyng, Carel B., additional, Kersten, Eveline, additional, Kilger, Ellen, additional, Langen, Hanno, additional, Lengyel, Imre, additional, Luthert, Phil, additional, Maugeais, Cyrille, additional, Meester-Smoor, Magda, additional, Monés, Jordi, additional, Nogoceke, Everson, additional, Peto, Tunde, additional, Pool, Frances M., additional, Rodríguez, Eduardo, additional, Ueffing, Marius, additional, Ulrich Bartz-Schmidt, Karl U., additional, van Leeuwen, Elisabeth M., additional, Verzijden, Timo, additional, Zumbansen, Markus, additional, Acar, Niyazi, additional, Anastosopoulos, Eleftherios, additional, Azuara-Blanco, Augusto, additional, Bergen, Arthur, additional, Binquet, Christine, additional, Bird, Alan, additional, Brétillon, Lionel, additional, Buitendijk, Gabrielle, additional, Cachulo, Maria Luz, additional, Chakravarthy, Usha, additional, Chan, Michelle, additional, Chang, Petrus, additional, Colijn, Johanna, additional, Cumberland, Philippa, additional, Cunha-Vaz, José, additional, Daien, Vincent, additional, Deak, Gabor, additional, Delyfer, Marie-Noëlle, additional, den Hollander, Anneke, additional, Dietzel, Martha, additional, Erke, Maja Gran, additional, Fauser, Sascha, additional, Finger, Robert, additional, Fletcher, Astrid, additional, Foster, Paul, additional, Founti, Panayiota, additional, Göbel, Arno, additional, Gorgels, Theo, additional, Grauslund, Jakob, additional, Grus, Franz, additional, Hammond, Christopher, additional, Helmer, Catherine, additional, Hense, Hans-Werner, additional, Hermann, Manuel, additional, Hoehn, René, additional, Hogg, Ruth, additional, Holz, Frank, additional, Hoyng, Carel, additional, Jansonius, Nomdo, additional, Janssen, Sarah, additional, Khawaja, Anthony, additional, Klaver, Caroline, additional, Lamparter, Julia, additional, Le Goff, Mélanie, additional, Leal, Sergio, additional, Lechanteur, Yara, additional, Lehtimäki, Terho, additional, Lotery, Andrew, additional, Leung, Irene, additional, Mauschitz, Matthias, additional, Merle, Bénédicte, additional, Meyer zu Westrup, Verena, additional, Midena, Edoardo, additional, Miotto, Stefania, additional, Mirshahi, Alireza, additional, Mohan-Saïd, Sadek, additional, Mueller, Michael, additional, Muldrew, Alyson, additional, Nunes, Sandrina, additional, Oexle, Konrad, additional, Rahi, Jugnoo, additional, Raitakari, Olli, additional, Ribeiro, Luisa, additional, Rougier, Marie-Bénédicte, additional, Sahel, José, additional, Salonikiou, Aggeliki, additional, Sanchez, Clarisa, additional, Schmitz-Valckenberg, Steffen, additional, Schweitzer, Cédric, additional, Shehata, Jasmin, additional, Silvestri, Giuliana, additional, Simader, Christian, additional, Souied, Eric, additional, Springelkamp, Henriet, additional, Tapp, Robyn, additional, Verhoeven, Virginie, additional, Von Hanno, Therese, additional, Vujosevic, Stela, additional, Williams, Katie, additional, Wolfram, Christian, additional, Yip, Jennifer, additional, Zerbib, Jennyfer, additional, and Zwiener, Isabella, additional

Published
2017
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33. T and genetic variations between Asian and Caucasian polypoidal choroidal vasculopathy

Author

Jordan-Yu, Janice Marie, Teo, Kelvin, Fan, Qiao, Gana, Jose Carlos, Leopando, Anna Karina, Nunes, Sandrina, Farinha, Cláudia, Barreto, Patricia, Melo, Joana Barbosa, Carreira, Isabel, Murta, Joaquim Neto, Silva, Rufino, and Cheung, Chui Ming Gemmy

Abstract

PurposeTo compare phenotypic and genetic variations in polypoidal choroidal vasculopathy (PCV) between Caucasian and Asian patients.MethodsWe analysed phenotypic and genotypic data from two sites, Association for Innovation and Biomedical Research on Light and Image, Portugal and Singapore National Eye Centre, Singapore. Baseline fundus photography, spectral domain-optical coherence tomography, indocyanine green and fluorescein angiography scans were analysed by respective reading centres using a standardised grading protocol. Single nucleotide polymorphisms across 8 PCV loci were compared between cases and controls selected from each population.ResultsOne hundred and forty treatment-nai¨ve PCV participants (35 Portuguese and 105 Singaporean) were included. The Portuguese cohort were older (72.33±8.44 vs 68.71±9.40 years, p=0.043) and were comprised of a lower proportion of males (43% vs 71%, p=0.005) compared with the Singaporean cohort. Differences in imaging features include higher prevalence of soft drusen (66% vs 30%, p=0.004), lower prevalence of subretinal haemorrhage (14% vs 67%, p<0.001), smaller polypoidal lesion (PL) area (0.09±0.09 vs 0.76±0.93 mm2, p<0.001), lower ratio of PL to branching vascular network area (3% vs 38%, p<0.001) and lower central retinal thickness (346.48±93.74 vs 493.16±212.92 µm, p<0.001) in the Portuguese cohort. CETP rs3764261(OR 2.467; 95% CI 1.282 to 4.745, p=0.006) in the Portuguese population was significantly associated with PCV and CFH rs800292(OR 1.719; 95% CI 1.139 to 2.596, p=0.010) in the Singaporean population, respectively.ConclusionAmong Asian and Caucasian patients with PCV, there are significant differences in the expression of phenotype. We also identified different polymorphisms associated with PCV in the two populations.

Published
2021
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34. Protocol for a randomised, double-masked, sham-controlled phase 4 study on the efficacy, safety and tolerability of intravitreal aflibercept monotherapy compared with aflibercept with adjunctive photodynamic therapy in polypoidal choroidal vasculopathy: the ATLANTIC study

Author

Marques, João Pedro, primary, Farinha, Cláudia, additional, Costa, Miguel Ângelo, additional, Ferrão, Ângela, additional, Nunes, Sandrina, additional, and Silva, Rufino, additional

Published
2017
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35. Safety Assessment of an A‐ScanUltrasonic System for Ophthalmic Use

Author

Petrella, Lorena, Fernandes, Paulo, Santos, Mário, Caixinha, Miguel, Nunes, Sandrina, Pinto, Carlos, Morgado, Miguel, Santos, Jaime, Perdigão, Fernando, and Gomes, Marco

Abstract

This study describes the safety assessment of an A‐scan ultrasonic system for ophthalmic use. The system is an investigational medical device for automatic cataract detection and classification. The risk management was based on the International Organization for Standardization (ISO) standard DIN EN ISO 14971:2009‐10 and International Electrotechnical Commission (IEC) standard IEC 60601‐2‐37. The calibration of the ultrasonic field was conducted according to the standards IEC 62127‐1:2007 and IEC 62359:2010. The uncertainty on measurements was delineated in agreement with the guide JCGM 100:2008. After risk management, all risks were qualitatively classified as acceptable. The mechanical index (0.08 ± 0.05), soft tissue thermal index (0.08 ± 0.08) and spatial‐peak temporal‐average intensity (0.56 ± 0.59 mW/cm2) were under the maximum index values indicated by the US Food and Drug Administration guidance, Marketing Clearance of Diagnostic Ultrasound Systems and Transducers(0.23, 1, and 17 mW/cm2, respectively). This study presents a practical approach for the safety assessment of A‐scan ultrasonic systems for ophthalmic use. The safety evaluation of a medical device is mandatory before its use in clinical practice. However, the safety monitoring throughout its life cycle should also be considered, since many device components may deteriorate over time and use.

Published
2020
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37. Age-related macular degeneration in Portugal: prevalence and risk factors in a coastal and an inland town. The Coimbra Eye Study - Report 2

Author

Cachulo, Maria da Luz, primary, Laíns, Inês, additional, Lobo, Conceição, additional, Figueira, João, additional, Ribeiro, Luísa, additional, Marques, João P., additional, Costa, José, additional, Vieira, António, additional, Rodrigues, João, additional, Alves, Dalila, additional, Nunes, Sandrina, additional, Costa, Miguel, additional, Rodrigues, Victor, additional, Cunha-Vaz, José, additional, Delcourt, Cecile, additional, and Silva, Rufino, additional

Published
2016
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38. Retinal layer location of increased retinal thickness in eyes with subclinical and clinical macular edema in diabetes type 2

Author

Bandello, Francesco, Tejerina, Amparo Navea, Vujosevic, Stela, Varano, Monica, Egan, Catherine, Sivaprasad, Sobha, Menon, Geeta, Massin, Pascale, Verbraak, Frank D, Lund-Andersen, Henrik, Martinez, Jose P, Jürgens, Ignasi, Smets, R M Erica, Coriat, Caroline, Wiedemann, Peter, Ágoas, Victor, Querques, Giuseppe, Holz, Frank G, Nunes, Sandrina, Alves, Dalila, Neves, Catarina, Santos, Torcato, Ribeiro, Luisa, Cunha-Vaz, José, Bandello, Francesco, Tejerina, Amparo Navea, Vujosevic, Stela, Varano, Monica, Egan, Catherine, Sivaprasad, Sobha, Menon, Geeta, Massin, Pascale, Verbraak, Frank D, Lund-Andersen, Henrik, Martinez, Jose P, Jürgens, Ignasi, Smets, R M Erica, Coriat, Caroline, Wiedemann, Peter, Ágoas, Victor, Querques, Giuseppe, Holz, Frank G, Nunes, Sandrina, Alves, Dalila, Neves, Catarina, Santos, Torcato, Ribeiro, Luisa, and Cunha-Vaz, José

Abstract

PURPOSE: To identify the retinal layer predominantly affected in eyes with subclinical and clinical macular edema in diabetes type 2.METHODS: A cohort of 194 type 2 diabetic eyes/patients with mild nonproliferative diabetic retinopathy (ETDRS levels 20/35) were examined with Cirrus spectral-domain optical coherence tomography (OCT) at the baseline visit (ClinicalTrials.gov identifier: NCT01145599). Automated segmentation of the retinal layers of the eyes with subclinical and clinical macular edema was compared with a sample of 31 eyes from diabetic patients with normal OCT and an age-matched control group of 58 healthy eyes.RESULTS: From the 194 eyes in the study, 62 had subclinical macular edema and 12 had clinical macular edema. The highest increases in retinal thickness (RT) were found in the inner nuclear layer (INL; 33.6% in subclinical macular edema and 81.8% in clinical macular edema). Increases were also found in the neighboring layers. Thinning of the retina was registered in the retinal nerve fiber, ganglion cells and inner plexiform layers in the diabetic eyes without macular edema.CONCLUSIONS: The increase in RT occurring in diabetic eyes with macular edema is predominantly located in the INL but extends to neighboring retinal layers indicating that it may be due to extracellular fluid accumulation.

Published
2015

39. One-year progression of diabetic subclinical macular edema in eyes with mild nonproliferative diabetic retinopathy:location of the increase in retinal thickness

Author

Tejerina, Amparo Navea, Vujosevic, Stela, Varano, Monica, Egan, Catherine, Sivaprasad, Sobha, Menon, Geeta, Massin, Pascale, Verbraak, Frank D, Lund-Andersen, Henrik, Martinez, Jose P, Jurgens, Ignasi, Smets, Erica, Coriat, Caroline, Wiedemann, Peter, Ágoas, Vitor, Querques, Giuseppe, Holz, Frank G, Nunes, Sandrina, Alves, Dalila, Neves, Catarina, Santos, Torcato, Ribeiro, Luisa, Bandello, Francesco, Cunha-Vaz, José, Tejerina, Amparo Navea, Vujosevic, Stela, Varano, Monica, Egan, Catherine, Sivaprasad, Sobha, Menon, Geeta, Massin, Pascale, Verbraak, Frank D, Lund-Andersen, Henrik, Martinez, Jose P, Jurgens, Ignasi, Smets, Erica, Coriat, Caroline, Wiedemann, Peter, Ágoas, Vitor, Querques, Giuseppe, Holz, Frank G, Nunes, Sandrina, Alves, Dalila, Neves, Catarina, Santos, Torcato, Ribeiro, Luisa, Bandello, Francesco, and Cunha-Vaz, José

Abstract

PURPOSE: To characterize the 1-year progression of retinal thickness (RT) increase occurring in eyes with subclinical macular edema in type 2 diabetes.METHODS: Forty-eight type 2 diabetic eyes/patients with mild nonproliferative diabetic retinopathy (NPDR; levels 20 and 35 in the Early Treatment Diabetic Retinopathy Study) classified as presenting subclinical macular edema at baseline completed the 1-year follow-up period, from a sample of 194 followed in a 12-month observational and prospective study (ClinicalTrials.gov identifier: NCT01145599). Automated segmentation of the retinal layers in these eyes was performed, followed by verification and correction by a human grader.RESULTS: The highest increase in RT over the 1-year follow-up period for the 48 eyes/patients with subclinical macular edema was found in the inner nuclear layer (INL). Progression to clinical macular edema was also associated with increased thickening of other retinal layers aside from the INL. The microvascular disease activity shown by microaneurysm (MA) turnover ≥6 was associated with progression from subclinical to clinical macular edema.CONCLUSIONS: Increases in RT occurring over a period of 1 year in diabetic eyes with mild NPDR and subclinical macular edema occur mainly in the INL. The development of clinical macular edema appears to be associated with increased thickening of other retinal layers and microvascular disease activity.

Published
2015

40. Characterization of Retinal Disease Progression in a 1-Year Longitudinal Study of Eyes With Mild Nonproliferative Retinopathy in Diabetes Type 2

Author

Ribeiro, Luisa, Bandello, Francesco, Tejerina, Amparo Navea, Vujosevic, Stela, Varano, Monica, Egan, Catherine, Sivaprasad, Sobha, Menon, Geeta, Massin, Pascale, Verbraak, Frank D, Lund-Andersen, Henrik, Martinez, Jose P, Jürgens, Ignasi, Smets, Erica, Coriat, Caroline, Wiedemann, Peter, Ágoas, Victor, Querques, Giuseppe, Holz, Frank G, Nunes, Sandrina, Neves, Catarina, Cunha-Vaz, José, Ribeiro, Luisa, Bandello, Francesco, Tejerina, Amparo Navea, Vujosevic, Stela, Varano, Monica, Egan, Catherine, Sivaprasad, Sobha, Menon, Geeta, Massin, Pascale, Verbraak, Frank D, Lund-Andersen, Henrik, Martinez, Jose P, Jürgens, Ignasi, Smets, Erica, Coriat, Caroline, Wiedemann, Peter, Ágoas, Victor, Querques, Giuseppe, Holz, Frank G, Nunes, Sandrina, Neves, Catarina, and Cunha-Vaz, José

Abstract

PURPOSE: To identify eyes of patients with diabetes type 2 that show progression of retinal disease within a 1-year period using noninvasive techniques.METHODS: Three hundred seventy-four type 2 diabetic patients with mild nonproliferative diabetic retinopathy (Early Treatment Diabetic Retinopathy Study [ETDRS] level 20 or 35) were included in a 12-month prospective observational study to identify retinopathy progression. Four visits were scheduled at 0, 3, 6, and 12 months. Microaneurysm (MA) activity using the RetmarkerDR and retinal thickness using spectral-domain optical coherence tomography (SD-OCT) were assessed by a central reading center at all visits and ETDRS severity level in the first and last visits.RESULTS: Three hundred thirty-one eyes/patients completed the study. Microaneurysm formation rate greater than or equal to 2 was present in 68.1% of the eyes and MA turnover greater than or equal to 6 in 54.0% at month 6. Higher MA turnover values were registered in eyes that showed progression in ETDRS severity level (P < 0.03). There were also significant correlations between increased microaneurysm activity and increases in retinal thickness. Spectral-domain OCT identified clinical macular edema in 24 eyes/patients (6.7%) and subclinical macular edema in 104 eyes/patients (28.9%) at baseline. Progression of retinal thickening was registered in eyes that had either subclinical or clinical macular edema at baseline.CONCLUSIONS: Changes in MA activity measured with RetmarkerDR and in central retinal thickness in eyes with mild nonproliferative diabetic retinopathy and diabetes type 2 are able to identify eyes at risk of progression. These eyes/patients should be selected for inclusion in future clinical trials of drugs targeted to prevent diabetic retinopathy progression to vision-threatening complications. (ClinicalTrials.gov number, NCT01145599.)

Published
2015

41. Relevance of Retinal Thickness Changes in the OCT Inner and Outer Rings to Predict Progression to Clinical Macular Edema:An Attempt of Composite Grading of Macular Edema

Author

Vujosevic, Stela, Varano, Monica, Egan, Catherine, Sivaprasad, Sobha, Menon, Geeta, Erginay, Ali, Verbraak, Frank D, Lund-Andersen, Henrik, Martinez, Jose P, Jürgens, Ignasi, Smets, Erica, Coriat, Caroline, Wiedemann, Peter, Ágoas, Victor, Querques, Giuseppe, Holz, Frank G, Nunes, Sandrina, Alves, Dalila, Neves, Catarina, Santos, Torcato, Ribeiro, Luisa, Bandello, Francesco, Tejerina, Amparo Navea, Cunha-Vaz, José, Vujosevic, Stela, Varano, Monica, Egan, Catherine, Sivaprasad, Sobha, Menon, Geeta, Erginay, Ali, Verbraak, Frank D, Lund-Andersen, Henrik, Martinez, Jose P, Jürgens, Ignasi, Smets, Erica, Coriat, Caroline, Wiedemann, Peter, Ágoas, Victor, Querques, Giuseppe, Holz, Frank G, Nunes, Sandrina, Alves, Dalila, Neves, Catarina, Santos, Torcato, Ribeiro, Luisa, Bandello, Francesco, Tejerina, Amparo Navea, and Cunha-Vaz, José

Abstract

PURPOSE: To characterize the relevance of macular thickness changes in the inner and outer rings in the progression of macular edema in eyes/patients with diabetes type 2.METHODS: A total of 374 type 2 diabetic patients with mild nonproliferative diabetic retinopathy (ETDRS levels 20-35) were included in a 12-month prospective observational study to identify retinopathy progression. Retinal thickness analyses were performed in 194 eyes/patients using Cirrus SD- OCT and 166 eyes/patients using Spectralis SD-OCT. The DRCR.net classification of subclinical and clinical macular edema was used. A composite grading of macular edema is proposed in this study.RESULTS: A total of 317 eyes/patients completed the study. SD-OCT identified clinical macular edema in 24 eyes/patients (6.7%) and subclinical macular edema in 104 eyes/patients (28.9%) at baseline. Increased thickness of the central subfield is the best predictor for the development of clinical macular edema, with 85.7% sensitivity and 71.9% specificity (OR: 2.57, 95% CI: 0.82-7.99). However, the involvement of the inner and outer rings is a cumulative predictor of progression to clinical macular edema (OR: 8.69, 95% CI: 2.85-26.52).CONCLUSIONS: A composite OCT grading of macular edema taking into account the retinal thickness changes in the inner and outer macular rings offers a simple way to characterize macular edema, with added clinical value.

Published
2015

43. Prevalence of Age-Related Macular Degeneration in Portugal: The Coimbra Eye Study - Report 1

Author

Cachulo, Maria da Luz, primary, Lobo, Conceição, additional, Figueira, João, additional, Ribeiro, Luisa, additional, Laíns, Inês, additional, Vieira, António, additional, Nunes, Sandrina, additional, Costa, Miguel, additional, Simão, Sílvia, additional, Rodrigues, Victor, additional, Vilhena, Nelson, additional, Cunha-Vaz, José, additional, and Silva, Rufino, additional

Published
2015
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44. Machine Learning Techniques in Clinical Vision Sciences.

Author

Caixinha, Miguel and Nunes, Sandrina

Subjects
*MACHINE learning, *EYE diseases, *BLINDNESS, *GENOMICS, *MEDICAL sciences
Abstract

This review presents and discusses the contribution of machine learning techniques for diagnosis and disease monitoring in the context of clinical vision science. Many ocular diseases leading to blindness can be halted or delayed when detected and treated at its earliest stages. With the recent developments in diagnostic devices, imaging and genomics, new sources of data for early disease detection and patients’ management are now available. Machine learning techniques emerged in the biomedical sciences as clinical decision-support techniques to improve sensitivity and specificity of disease detection and monitoring, increasing objectively the clinical decision-making process. This manuscript presents a review in multimodal ocular disease diagnosis and monitoring based on machine learning approaches. In the first section, the technical issues related to the different machine learning approaches will be present. Machine learning techniques are used to automatically recognize complex patterns in a given dataset. These techniques allows creating homogeneous groups (unsupervised learning), or creating a classifier predicting group membership of new cases (supervised learning), when a group label is available for each case. To ensure a good performance of the machine learning techniques in a given dataset, all possible sources of bias should be removed or minimized. For that, the representativeness of the input dataset for the true population should be confirmed, the noise should be removed, the missing data should be treated and the data dimensionally (i.e., the number of parameters/features and the number of cases in the dataset) should be adjusted. The application of machine learning techniques in ocular disease diagnosis and monitoring will be presented and discussed in the second section of this manuscript. To show the clinical benefits of machine learning in clinical vision sciences, several examples will be presented in glaucoma, age-related macular degeneration, and diabetic retinopathy, these ocular pathologies being the major causes of irreversible visual impairment. [ABSTRACT FROM PUBLISHER]

Published
2017
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45. Ranibizumab for High-Risk Proliferative Diabetic Retinopathy: An Exploratory Randomized Controlled Trial.

Author

Figueira, João, Silva, Rufino, Henriques, José, Caldeira Rosa, Paulo, Laíns, Inês, Melo, Pedro, Gonçalves Nunes, Sandrina, and Cunha-Vaz, José

Subjects
DIABETIC retinopathy, VASCULAR endothelial growth factors, RANIBIZUMAB, LIGHT coagulation, RETINAL diseases
Abstract

Purpose: To compare the efficacy and safety of intravitreal ranibizumab (IVR) in monotherapy or associated with panretinal photocoagulation (PRP) versus conventional PRP, for high-risk proliferative diabetic retinopathy (PDR) without vitreoretinal traction. Procedures: Multicenter randomized trial, with 3 treatment arms: PRP versus IVR alone and PRP + IVR combined treatment. Follow-up was performed at months 3, 6 and 12. Results: Thirty-five subjects were randomized and 32 used for analysis. Complete regression of neovessels elsewhere occurred in 100% (PRP + IVR), 75% (IVR) and 69.2% (PRP) and for neovessels of the disk in 44.4% (PRP + IVR), 37.5% (IVR) and 30.8% (PRP). During the 1-year duration of treatment, there was no need for laser rescue treatment in IVR-treated eyes. Conclusions: This trial suggests that the use of IVR is safe and may have a beneficial effect in the treatment of eyes with high-risk PDR. Message: Ranibizumab appears to have a place in the treatment of PDR. © 2015 S. Karger AG, Basel [ABSTRACT FROM AUTHOR]

Published
2016
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46. Relevance of Retinal Thickness Changes in the OCT Inner and Outer Rings to Predict Progression to Clinical Macular Edema: An Attempt of Composite Grading of Macular Edema.

Author

Vujosevic, Stela, Varano, Monica, Egan, Catherine, Sivaprasad, Sobha, Menon, Geeta, Erginay, ali, Verbraak, Frank D., Lund-andersen, Henrik, Martinez, Jose P., Jürgens, Ignasi, Smets, Erica, Coriat, Caroline, Wiedemann, Peter, Ágoas, Victor, Querques, Giuseppe, Holz, Frank G., Nunes, Sandrina, alves, Dalila, Neves, Catarina, and Santos, Torcato

Subjects
MACULA lutea, RETINAL diseases, PEOPLE with diabetes, DIABETIC retinopathy, OPTICAL coherence tomography, PATIENTS, DISEASES
Abstract

Purpose: To characterize the relevance of macular thickness changes in the inner and outer rings in the progression of macular edema in eyes/patients with diabetes type 2. Methods: A total of 374 type 2 diabetic patients with mild nonproliferative diabetic retinopathy (ETDRS levels 20-35) were included in a 12-month prospective observational study to identify retinopathy progression. Retinal thickness analyses were performed in 194 eyes/patients using Cirrus SD- OCT and 166 eyes/patients using Spectralis SD-OCT. The DRCR.net classification of subclinical and clinical macular edema was used. A composite grading of macular edema is proposed in this study. Results: A total of 317 eyes/patients completed the study. SD-OCT identified clinical macular edema in 24 eyes/patients (6.7%) and subclinical macular edema in 104 eyes/patients (28.9%) at baseline. Increased thickness of the central subfield is the best predictor for the development of clinical macular edema, with 85.7% sensitivity and 71.9% specificity (OR: 2.57, 95% CI: 0.82-7.99). However, the involvement of the inner and outer rings is a cumulative predictor of progression to clinical macular edema (OR: 8.69, 95% CI: 2.85-26.52). Conclusions: A composite OCT grading of macular edema taking into account the retinal thickness changes in the inner and outer macular rings offers a simple way to characterize macular edema, with added clinical value. © 2015 S. Karger AG, Basel [ABSTRACT FROM AUTHOR]

Published
2015
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47. One-Year Progression of Diabetic Subclinical Macular Edema in Eyes with Mild Nonproliferative Diabetic Retinopathy: Location of the Increase in Retinal Thickness.

Author

Tejerina, amparo Navea, Vujosevic, Stela, Varano, Monica, Egan, Catherine, Sivaprasad, Sobha, Menon, Geeta, Massin, Pascale, Verbraak, Frank D., Lund-andersen, Henrik, Martinez, Jose P., Jurgens, Ignasi, Smets, Erica, Coriat, Caroline, Wiedemann, Peter, Ágoas, Vitor, Querques, Giuseppe, Holz, Frank G., Nunes, Sandrina, alves, Dalila, and Neves, Catarina

Subjects
DIABETIC retinopathy treatment, EDEMA, RETINAL anatomy, DISEASE progression, MICROCIRCULATION disorders
Abstract

Purpose: To characterize the 1-year progression of retinal thickness (RT) increase occurring in eyes with subclinical macular edema in type 2 diabetes. Methods: Forty-eight type 2 diabetic eyes/patients with mild nonproliferative diabetic retinopathy (NPDR; levels 20 and 35 in the Early Treatment Diabetic Retinopathy Study) classified as presenting subclinical macular edema at baseline completed the 1-year follow-up period, from a sample of 194 followed in a 12-month observational and prospective study (ClinicalTrials.gov identifier: NCT01145599). Automated segmentation of the retinal layers in these eyes was performed, followed by verification and correction by a human grader. Results: The highest increase in RT over the 1-year follow-up period for the 48 eyes/patients with subclinical macular edema was found in the inner nuclear layer (INL). Progression to clinical macular edema was also associated with increased thickening of other retinal layers aside from the INL. The microvascular disease activity shown by microaneurysm (MA) turnover ≥6 was associated with progression from subclinical to clinical macular edema. Conclusions: Increases in RT occurring over a period of 1 year in diabetic eyes with mild NPDR and subclinical macular edema occur mainly in the INL. The development of clinical macular edema appears to be associated with increased thickening of other retinal layers and microvascular disease activity. © 2015 S. Karger AG, Basel [ABSTRACT FROM AUTHOR]

Published
2015
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48. Genetic Variants in ICAM1, PPARGC1A and MTHFR Are Potentially Associated with Different Phenotypes of Diabetic Retinopathy.

Author

Simões, Maria José, Lobo, Conceição, Egas, Conceição, Nunes, Sandrina, Carmona, Susana, Costa, Miguel Ângelo, Duarte, Tânia, Ribeiro, Luísa, Faro, Carlos, and Cunha-Vaz, José G.

Subjects
PHENOTYPES, SINGLE nucleotide polymorphisms, DIABETIC retinopathy, DIABETES complications, RETINAL diseases
Abstract

Purpose: To explore phenotype-genotype correlations that may contribute to a better understanding of diabetic retinopathy (DR). Procedures: An exploratory association study was performed to identify genetic variants associated with non-proliferative DR (NPDR) in 307 type 2 diabetic patients who were previously stratified into 3 different phenotypes of NPDR progression. The 307 patients were genotyped for 174 single nucleotide polymorphisms of 11 candidate genes (ACE, AGER, AKR1B1, ICAM1, MTHFR, NOS1, NOS3, PPARGC1A, TGFB1, TNF and VEGFA). Results: Significant associations were observed for PPARGC1A rs16874120 with phenotype A (odds ratio, OR = 0.60, 95% confidence interval, CI 0.36-0.99), ICAM1 rs1801714 with phenotype B (OR = 3.32, 95% CI 1.05-10.50) and both PPARGC1A rs10213440 (OR = 2.00, 95% CI 1.07-3.73) and MTHFR rs1801133 (OR = 1.84, 95% CI 1.08-3.11) with phenotype C. Conclusions: Results indicate that specific gene variants in ICAM1, PPARGC1A and MTHFR are associated with different NPDR phenotypes, being likely candidates to explain different disease mechanisms underlying the different phenotypes. This is the first study to show correlations between specific gene variants and NPDR phenotypes, opening new perspectives on DR. © 2014 S. Karger AG, Basel [ABSTRACT FROM AUTHOR]

Published
2014
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49. Ranibizumab Plus Panretinal Photocoagulation versus Panretinal Photocoagulation Alone for High-Risk Proliferative Diabetic Retinopathy (PROTEUS Study)

Author

Sarah Ayello Scheer, Emily Fletcher, Dalila Alves, Conceição Lobo, Catherine Creuzot-Garcher, Rufino Silva, João Figueira, Haralabos Eleftheriadis, João Nascimento, Miguel Amaro, Sandrina Nunes, Monica Varano, Pascale Massin, Geeta Menon, Francesco Bandello, Sobha Sivaprasad, José Cunha-Vaz, Edoardo Midena, Association for Innovation and Biomedical Research on Light and Image (AIBILI), Gloucestershire Hospitals, Partenaires INRAE, Hôpital Lariboisière-Fernand-Widal [APHP], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP), Universita Vita Salute San Raffaele = Vita-Salute San Raffaele University [Milan, Italie] (UniSR), Universita di Padova, IRCCS, King's Health Partners, Frimley Park Hospital NHS Foundation Trust, Hospital Vila Franca de Xira, Centre Hospitalier National d'Ophtalmologie des Quinze-Vingts (CHNO), Centre des Sciences du Goût et de l'Alimentation [Dijon] (CSGA), Centre National de la Recherche Scientifique (CNRS)-AgroSup Dijon - Institut National Supérieur des Sciences Agronomiques, de l'Alimentation et de l'Environnement-Institut National de la Recherche Agronomique (INRA)-Université de Bourgogne (UB), Department of Ophthalmology, Centre Hospitalier Universitaire de Dijon - Hôpital François Mitterrand (CHU Dijon), Instituto de Retina e Diabetes Ocular de Lisboa, Novartis, Bayer, Allergan, Roche, EVICR, Thea, Horus, Novartis Pharma AG., Figueira, João, Fletcher, Emily, Massin, Pascale, Silva, Rufino, Bandello, Francesco, Midena, Edoardo, Varano, Monica, Sivaprasad, Sobha, Eleftheriadis, Haralabo, Menon, Geeta, Amaro, Miguel, Ayello Scheer, Sarah, Creuzot-Garcher, Catherine, Nascimento, João, Alves, Dalila, Nunes, Sandrina, Lobo, Conceição, and Cunha-Vaz, José

Subjects
Male, Vascular Endothelial Growth Factor A, Visual acuity, medicine.medical_treatment, Visual Acuity, Angiogenesis Inhibitors, Vitrectomy, Retinal Neovascularization, law.invention, chemistry.chemical_compound, 0302 clinical medicine, Randomized controlled trial, law, Prospective Studies, Fluorescein Angiography, Prospective cohort study, Tomography, Laser Coagulation, Diabetic retinopathy, Middle Aged, Combined Modality Therapy, 3. Good health, Intravitreal Injections, Retreatment, Female, medicine.symptom, Tomography, Optical Coherence, medicine.drug, Adult, medicine.medical_specialty, 03 medical and health sciences, Ranibizumab, Ophthalmology, medicine, Humans, [SDV.MHEP.OS]Life Sciences [q-bio]/Human health and pathology/Sensory Organs, Aged, Diabetic Retinopathy, business.industry, medicine.disease, chemistry, Optical Coherence, Vitreous hemorrhage, 030221 ophthalmology & optometry, Glycated hemoglobin, business, [SDV.MHEP]Life Sciences [q-bio]/Human health and pathology, 030217 neurology & neurosurgery
Abstract

Supplemental material available at www.aaojournal.org.; International audience; PURPOSE: Comparison of the efficacy of ranibizumab (RBZ) 0.5 mg intravitreal injections plus panretinal photocoagulation (PRP) versus PRP alone in the regression of the neovascularization (NV) area in subjects with high-risk proliferative diabetic retinopathy (HR-PDR) over a 12-month period. DESIGN: Prospective, randomized, multicenter, open-label, phase II/III study. PARTICIPANTS: Eighty-seven participants (aged >/=18 years) with type 1/2 diabetes and HR-PDR (mean age, 55.2 years; 37% were female). METHODS: Participants were randomized (1:1) to receive RBZ+PRP (n = 41) or PRP monotherapy (n = 46). The RBZ+PRP group received 3 monthly RBZ injections along with standard PRP. The PRP monotherapy group received standard PRP between day 1 and month 2; thereafter, re-treatments in both groups were at the investigators' discretion. MAIN OUTCOME MEASURES: The primary outcome was regression of NV total, on the disc (NVD) plus elsewhere (NVE), defined as any decrease in the area of NV from the baseline to month 12. Secondary outcomes included best-corrected visual acuity (BCVA) changes from baseline to month 12, time to complete NV regression, recurrence of NV, macular retinal thickness changes from baseline to month 12, need for treatment for diabetic macular edema, need for vitrectomy because of occurrence of vitreous hemorrhage, tractional retinal detachment or other complications of DR, and adverse events (AEs) related to treatments. RESULTS: Seventy-seven participants (88.5%) completed the study. Overall baseline demographics were similar for both groups, except for age. At month 12, 92.7% of participants in the RBZ+PRP group presented NV total reduction versus 70.5% of the PRP monotherapy participants (P = 0.009). The number of participants with NVD and NVE reductions was higher with RBZ+PRP (93.3% and 91.4%, respectively) versus PRP (68.8% and 73.7%, respectively), significant only for NVE (P = 0.048). Complete NV total regression was observed in 43.9% in the RBZ+PRP group versus 25.0% in the PRP monotherapy group (P = 0.066). At month 12, the mean BCVA was 75.2 letters (20/32) in the RBZ+PRP group versus 69.2 letters (20/40) in the PRP monotherapy group (P = 0.104). In the RBZ+PRP group, the mean number of PRP treatments over month 12 was 3.5+/-1.3, whereas in the PRP monotherapy group, it was 4.6+/-1.5 (P = 0.001). No deaths or unexpected AEs were reported. CONCLUSIONS: Treatment with RBZ+PRP was more effective than PRP monotherapy for NV regression in HR-PDR participants over 12 months.

Published
2018

50. A Importância da Monitorização Baseada no Risco na Investigação Clínica

Author

Silva, Daniel Filipe Leite, Nunes, Sandrina Gonçalves, and Simões, Sérgio Paulo Magalhães

Subjects
Centralized Monitoring, Monitorização Targetted and Targetted, Clinical Research, Monitorização Baseada no Risco, Targetted and Triggered Monitoring, Monitorização Centralizada, Investigação Clínica, Source Data Verification, Risk-Based Monitoring
Published
2019

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