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1. Complications after proton therapy of choroidal melanoma: A case report.

Author

Kukova, N., Molnarova, M., and Stefanickova, J.

Subjects
MELANOMA diagnosis, PROTON therapy, CHOROID diseases, RADIATION dosimetry, ULTRASONIC imaging
Abstract

Proton beam therapy is a globe preserving treatment method of choroidal melanoma. It is considered to be less harmful for the tissues around the tumour but the complications such as radiation retinopathy and neuropathy occur according to the dosage of irradiation. The visual outcomes after treatment are variable and dependent on the size of tumour. This article presents a case report of a 44-year-old male with choroidal melanoma in the left eye. Patient was examined in our ophthalmology practice because of photopsia and blurry vision during physical activity. After full ophthalmologic examination, fundus photography, optic coherent tomography, fluoresceine angiography and ultrasonography the diagnosis of malignant melanoma of choroid was set. The patient was referred to a proton center to undergo a proton therapy of choroidal melanoma in the left eye. Follow-up treatment of severe postradiation retinopathy and neuropathy is presented in the article. The patient took intravitreal bevacizumab injections and the panretinal lasercoagulation was performed. After one and half year follow up the melanoma is stable after therapy with no metastases. [ABSTRACT FROM AUTHOR]

Published
2023
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2. Eine randomisierte Phase-IIIb-Vergleichsstudie zu drei intravitrealen Aflibercept-Dosisregimen nach dem ersten Behandlungsjahr bei Patienten mit diabetischem Makulaödem: Ergebnisse der 100-wöchigen VIOLET-Studie

Author

Garweg, JG, Sivaprasad, S, Stefanickova, J, Hoyng, C, Niesen, T, Schmelter, T, and Leal, S

Subjects
ddc: 610, 610 Medical sciences, Medicine
Abstract

Hintergrund: VIOLET schloss Patienten mit diabetischem-Makulaödem (DMÖ) ein, die bereits 1 Jahr intravitreales Aflibercept 2mg (IVT-AFL) behandelt erhielten. Primäres Ziel war die Untersuchung, ob zwei flexible IVT-AFL-Regime (Treat-and-Extend [T&E] und Pro-Re-Nata [PRN])[zum vollständigen Text gelangen Sie über die oben angegebene URL], 33. Jahrestagung der Retinologischen Gesellschaft

Published
2021
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3. Vision-Related Quality of Life in Patients with Diabetic Macular Edema Treated with Intravitreal Aflibercept: The AQUA Study

Author

Garweg, Jg, Stefanickova, J, Hoyng, C, Schmelter, T, Niesen, T, Sowade, O, Sivaprasad, S, Adan, A, Alexik, M, Ali, F, Amaro, M, Balciuniene, V, Bandello, Fm, Arias Barquet, L, Beck, A, Bell, K, Boscia, F, Bures, A, Carneiro, A, Chow, Dr, Cimbalas, A, Dahlke, C, Deepali, V, Dickinson, Jd, Dollin, M, Eandi, C, Emmerich, K, Feltgen, N, Pereira Figueira, J, Findl, O, Gajdosova, M, Gale, Rp, John Galic, I, Garweg, J, Gasser-Steiner, V, Giunta, M, Gonder, Jr, Grzybowski, A, Hamouz, J, Hattenbach, L, Holz, Fg, Jesia, H, Kaluzny, J, Kerenyi, A, Kertes, Pj, Koch, F, Kodjikan, L, Lederer, De, Liehneova, I, Lorenz, K, Lotery, Aj, Mckibbin, M, Menon, Gv, Michalewska, Z, Midena, E, Nicolo, M, Papp, A, Pavlovicova, G, Peiretti, E, Vaz-Pereira, S, Perri, P, Petropoulos, I, Queguiner, F, Raczynska, K, Sararols-Ramsay, L, Rekas, M, Ricci, F, Romanowska-Dixon, B, Sachs, Hg, Mohand-Said, S, Sandner, D, Schmidt-Erfurth, U, Sekundo, W, Seres, A, Souied, E, Castro de Sousa, J, Stankiewicz, A, Struharova, K, Studnicka, J, Cervera Taulet, E, Taylor, S, Teper, S, Vajas, A, Cava Valenciano, C, Varsanyi, B, Viola, F, Virgili, G, Wagenfeld, L, Walters, G, Wiedemann, P, Zarnowski, T, Garweg, J. G., Stefanickova, J., Hoyng, C., Schmelter, T., Niesen, T., Sowade, O., Sivaprasad, S., Adan, A., Alexik, M., Ali, F., Amaro, M., Balciuniene, V. -J., Bandello, F. M., Arias Barquet, L., Beck, A., Bell, K., Boscia, F., Bures, A., Carneiro, A., Chow, D. R., Cimbalas, A., Dahlke, C., Deepali, V., Dickinson, J. D., Dollin, M., Eandi, C., Emmerich, K. -H., Feltgen, N., Pereira Figueira, J., Findl, O., Gajdosova, M., Gale, R. P., John Galic, I., Garweg, J., Gasser-Steiner, V., Giunta, M., Gonder, J. R., Grzybowski, A., Hamouz, J., Hattenbach, L. -O., Holz, F. G., Jesia, H., Kaluzny, J., Kerenyi, A., Kertes, P. J., Koch, F., Kodjikan, L., Lederer, D. E., Liehneova, I., Lorenz, K., Lotery, A. J., Mckibbin, M., Menon, G. V., Michalewska, Z., Midena, E., Nicolo, M., Papp, A., Pavlovicova, G., Peiretti, E., Vaz-Pereira, S., Perri, P., Petropoulos, I., Queguiner, F., Raczynska, K., Sararols-Ramsay, L., Rekas, M., Ricci, F., Romanowska-Dixon, B., Sachs, H. G., Mohand-Said, S., Sandner, D., Schmidt-Erfurth, U., Sekundo, W., Seres, A., Souied, E., Castro de Sousa, J., Stankiewicz, A., Struharova, K., Studnicka, J., Cervera Taulet, E., Taylor, S., Teper, S., Vajas, A., Cava Valenciano, C., Varsanyi, B., Viola, F., Virgili, G., Wagenfeld, L., Walters, G., Wiedemann, P., and Zarnowski, T.

Subjects
Male, Vascular Endothelial Growth Factor A, Diabetic Retinopathy, Recombinant Fusion Proteins, Visual Acuity, Angiogenesis Inhibitors, Middle Aged, Macular Edema, Diabetes Mellitus, Type 1, Receptors, Vascular Endothelial Growth Factor, Diabetes Mellitus, Type 2, Settore MED/30, Sickness Impact Profile, Surveys and Questionnaires, Intravitreal Injections, Quality of Life, Humans, Female, Single-Blind Method, Tomography, Optical Coherence, Vision, Ocular, Aged
Abstract

Purpose: To examine vision-related quality of life in patients with diabetic macular edema (DME) treated with intravitreal aflibercept (EYLEA, Regeneron Pharmaceuticals, Inc, Tarrytown, NY). Design: AQUA was a multicenter, open-label, single-arm, phase 4 study. Participants: Adults 18 years of age or older with type 1 or 2 diabetes mellitus and DME. Methods: Patients received intravitreal aflibercept 2 mg every 8 weeks for 52 weeks, after 5 initial doses every 4 weeks. Main Outcome Measures: The primary outcome was the change in 25-item National Eye Institute Visual Function Questionnaire (NEI VFQ-25) total score from baseline to week 52. Secondary outcomes included the change in NEI VFQ-25 near and distant activities subscale scores, best-corrected visual acuity (BCVA; Early Treatment Diabetic Retinopathy Study [ETDRS] letters), and central retinal thickness (CRT) from baseline to week 52. Change in NEI VFQ-25 score at week 52 for better-seeing eyes (BSEs) and worse-seeing eyes (WSEs) also was evaluated. Results: A total of 553 patients comprised the full analysis set, and 560 patients comprised the safety analysis set. At baseline, the mean NEI VFQ-25 total score was 70.12, mean BCVA was 61.5 ETDRS letters, and mean CRT was 464.81 μm. A mean of 8.8 injections were administered over 52 weeks. At week 52, the mean improvement from baseline in the NEI VFQ-25 total score was +6.11 (standard deviation [SD], 11.46); the corresponding improvements in near and distant activities were +11.37 (SD, 18.01) and +7.33 (SD, 17.32), respectively. Similarly, improvements in patients whose BSE and WSE were treated were 7.74 (SD, 13.59) and 5.48 (SD, 9.70), respectively. At week 52, mean change in BCVA was +10.0 ETDRS letters (SD, 8.0 ETDRS letters), and mean change in CRT was –175.38 μm (SD, 132.62 μm). Overall, 53.6% of patients reported treatment-emergent adverse events (TEAEs), of whom 26.8% experienced an ocular TEAE in the study eye. The most common serious ocular TEAE was endophthalmitis (0.5% [n = 3]). Five deaths (0.9%) were reported, but were not considered treatment related. Conclusions: Intravitreal aflibercept was associated with clinically meaningful improvements in NEI VFQ-25 total score over 52 weeks in patients with DME; these were even more pronounced for near than for distant activities. Adverse events were consistent with the known safety profile of intravitreal aflibercept.

Published
2019

4. An international collaborative evaluation of central serous chorioretinopathy: different therapeutic approaches and review of literature. The European Vitreoretinal Society central serous chorioretinopathy study

Author

Romano, M. R., Parolini, B., Allegrini, D., Mickalewska, Z., Adelman, R., Bonovas, S., Bopp, S., Citirik, M., Tekin, K., Fiser, I., Boon, C. J. F., Van, D., Donvito, G., Gungel, H., Ozdogan Erkul, S., Unsal, E., Osmanbasoglu, O., Dincer, N., Ercalik, N. Y., Yenerel, N. M., Amar, J. -P., Ennemoser, A., Besozzi, G., Sallam, A. A. B., Ellabban, A. A., Chang, W., Eandi, C. M., Demir, M., Lee, J., Pak, K., Arrevola, L., Sloka, A., Morawski, K., Kulig - Stochmal, A., Romanowska - Dixon, B., Striebe, N. -A., Feltgen, N., Hoerauf, H., Inan, U. U., Tanev, I., Dyrda, A., Schuler, A., Lucke, K., Brix, A., Pape, S., Kusserow-Napp, C., Loo, P. A., Kanra, A. Y., Ardagil Akcakaya, A., Ari Yaylali, S., Bae, S. H., Kim, H. K., Kim, S. J., Han, J. R., Nam, W. H., Odrobina, D., Lavaque, E., Bertelli, E., Coser, S., Ziemssen, F., Forlini, M., Benatti, C., Cavallini, G. M., Stefanickova, J., Berrod, J. -P., Saksonov, S., Lytvinchuk, L., Moussa, M., Stefaniotou, M., Christodoulou, E., Zayed, M. A., Oz, O., Tassinari, P., Koch, P., Declercq, C., Johnston, R., Rusnak, S., Penas, S., Ozdek, S., Ucgul, Y., Cisiecki, S., Dziegielewski, K., Klimczak, D., Michalewska, Z., Michalewski, J., Nawrocka, Z., Nawrocki, J., Ornafel, K., Pikulski, Z., Maciej, M., Acar, N., Elshafei, M. M., Hamon, F., Soyeur, R., Badat, I., Brousseau, B., Hermouet, E., Peiretti, E., Lee, J. -H., Ferreira, N., Yoon, H. -S., Alkhars, W. I., Dudani, A., Minu, R., Telang, O., Morepatil, V. G., Furtado, M. J., Y. -J., Jo, Piccolino, F. C., Finzi, A., Ophthalmology, and Amsterdam Neuroscience - Complex Trait Genetics

Subjects
Pars plana, medicine.medical_specialty, Visual acuity, medicine.medical_treatment, Vitrectomy, 03 medical and health sciences, 0302 clinical medicine, PDT, Ophthalmology, medicine, central serous chorioretinopathy, First episode, Aspirin, Univariate analysis, medicine.diagnostic_test, business.industry, General Medicine, Fluorescein angiography, eye diseases, laser, Serous fluid, medicine.anatomical_structure, 030221 ophthalmology & optometry, medicine.symptom, business, 030217 neurology & neurosurgery, medicine.drug
Abstract

Purpose: To study and compare the efficacy of different therapeutic options for the treatment of central serous chorioretinopathy (CSCR). Methods: This is a nonrandomized, international multicentre study on 1719 patients (1861 eyes) diagnosed with CSCR, from 63 centres (24 countries). Reported data included different methods of treatment and both results of diagnostic examinations [fluorescein angiography and/or optical coherent tomography (OCT)] and best-corrected visual acuity (BCVA) before and after therapy. The duration of observation had a mean of 11 months but was extended in a minority of cases up to 7 years. The aim of this study is to evaluate the efficacy of the different therapeutic options of CSCR in terms of both visual (BCVA) and anatomic (OCT) improvement. Results: One thousand seven hundred nineteen patients (1861 eyes) diagnosed with CSCR were included. Treatments performed were nonsteroidal anti-inflammatory eye drops, laser photocoagulation, micropulse diode laser photocoagulation, photodynamic therapy (PDT; Standard PDT, Reduced-dose PDT, Reduced-fluence PDT), intravitreal (IVT) antivascular endothelial growth factor injection (VEGF), observation and other treatments. The list of the OTHERS included both combinations of the main proposed treatments or a variety of other treatments such as eplerenone, spironolactone, acetazolamide, beta-blockers, anti-anxiety drugs, aspirin, folic acid, methotrexate, statins, vitis vinifera extract medication and pars plana vitrectomy. The majority of the patients were men with a prevalence of 77%. The odds ratio (OR) showed a partial or complete resolution of fluid on OCT with any treatment as compared with observation. In univariate analysis, the anatomical result (improvement in subretinal fluid using OCT at 1 month) was favoured by age 500 μm (p = 0.03). The OR for obtaining partial or complete resolution showed that anti-VEGF and eyedrops were not statistically significant; whereas PDT (8.5), thermal laser (11.3) and micropulse laser (8.9) lead to better anatomical results with less variability. In univariate analysis, the functional result at 1 month was favoured by first episode (p = 0.04), height of subretinal fluid >500 μm (p

Published
2019
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5. A noninterventional study to monitor patients with diabetic macular oedema starting treatment with ranibizumab (POLARIS)

Author

Stefanickova J., Cunha-Vaz J., Ulbig M., Pearce I., Fernandez-Vega Sanz A., Theodossiadis P., Kodjikian L., Izmailov A., Muston D., Vassilev Z., Lamotte B., Tuckmantel C., Friedl S., Altemark A., Schwarz H. -J., Katz T., Souied E., Lalloum F., Querques G., Ayello-Scheer S., Coriat C., Girens J. F., Sahel J. -A., Creuzot-Garcher C., Bremond-Gignac D., Chiambaretta F., Farguette F., Delhay C., Baillif-Gostoli S., Maschi C., Fajnkuchen F., Milazzo S., Benzerroug M., Theron J. P., Schmickler S., Zywien A., Bopp S., Hoh H., Campean P., Schattmann K., Fromberg I., Fromberg C., Fromberg D., Spital G., Heimes B., Emmerich K. -H., Lang M., Krieb A., Xafis G., Stock L., Klotz N., Ungerechts R., Matuschek A., Radermacher M., Thelen U., Tetz M., Denisiuk M., Berens U., Schumacher A., Neuhann T., Lange O., Richard G., Wieland M., Filev F., Bittersohl D., Wiedemann P., Lorenz K., Wasielica-Poslednik J., Rosbach J., Dave H., Wirtz N., Weber B., Gelisken F., Wilhelm B., Peters T., Konig T., Kampik A., Abbasova S., Wolf A., Kurz S., Herold T., Arend N., Dabov S., Prause K., Fazekas C., Martz J., Bayerl K., Heuer U., Bischoff G., Kunne C., Lorenz B., Jager M., Schiel H., Datseris I., Diamanti-Ramza A., Charonis A., Straga I., Babouli N., Brevetti C., Tranos P., Perganta G., Panayiotis T., Angeliki A., Dinioti T., Tsironi E., Kotoula M., Brazitikos P., Nanas D., Figueira J., Ribeiro L., Molodkina N., Abdulaeva E., Pashtaev N., Ovchinnikova V., Yurieva T., Vaycheslav B., Liya R., Ahlers J., Zmatlova I., Popovcova M., Bajacek J., Panisova J., Struharova K., Sturova L., Jamrichova Z., Krasnik V., Krajcova P., Hasa J., Piovarciova E., Gajdosova M., Vida R., Janco L., Leskova V., Demsky P., Alexik M., Falatova A., Lipkova B., Stubna M., Tomaskova D., Herle D., Martinez Alday N., Sanchez Aparicio J. A., Martinez Anton M., Lopez Galvez M. I., Manzanas Leal L., Juberias Sanchez R., Perez Belmonte L., Fernandez-Vega Sanz B., Villota Deleu E., Gloria D. L. T. C., Canga S., De Santiago Rodiguez M. A., Ramos Gonzalez D., Prieto Maratin J. F., Franco Suarez-Barcena I., Casado Prieto A., Hernandez Galilea E., Gomez Ledesma I., de Juan Marco L., Mendivil Soto M. P., Bearan I., Nunez M., Lopez Garrido J. L., Rodriguez Raton A., Cincunegui J., Vazquez Cruchaga E., Quiroga de la Hera P., Fernandez Rodriguez M., Rodriguez Cid M. J., Mendez Martinez S., Gonzalez Martinez A., Gomez-Ulla F., Garcia Garces I., Martinez Perez L., Mansilla Cunarro R., Abraldes Lopez-Veiga M., Rodriguez Nunez M., Pineiro Figuera M. C., Rodriguez Ferro F., Menon G., North L., Chandran M., Retnamma R., Sivaprasad S., Taylor S., Scanlon P., Johnston R., Chong V., Mall S., Bailey C., Varma D., Talks J., Lotery A., Thulasidharan S., Eckstein M., Fahd Q., Koshy Z., Hanumanthu S., Kelly S., Evangelos S., Ghanchi F., Asaria R., Harris M., Derdeb T., Dipa G., Mahuma I., Stefanickova, J., Cunha-Vaz, J., Ulbig, M., Pearce, I., Fernandez-Vega Sanz, A., Theodossiadis, P., Kodjikian, L., Izmailov, A., Muston, D., Vassilev, Z., Lamotte, B., Tuckmantel, C., Friedl, S., Altemark, A., Schwarz, H. -J., Katz, T., Souied, E., Lalloum, F., Querques, G., Ayello-Scheer, S., Coriat, C., Girens, J. F., Sahel, J. -A., Creuzot-Garcher, C., Bremond-Gignac, D., Chiambaretta, F., Farguette, F., Delhay, C., Baillif-Gostoli, S., Maschi, C., Fajnkuchen, F., Milazzo, S., Benzerroug, M., Theron, J. P., Schmickler, S., Zywien, A., Bopp, S., Hoh, H., Campean, P., Schattmann, K., Fromberg, I., Fromberg, C., Fromberg, D., Spital, G., Heimes, B., Emmerich, K. -H., Lang, M., Krieb, A., Xafis, G., Stock, L., Klotz, N., Ungerechts, R., Matuschek, A., Radermacher, M., Thelen, U., Tetz, M., Denisiuk, M., Berens, U., Schumacher, A., Neuhann, T., Lange, O., Richard, G., Wieland, M., Filev, F., Bittersohl, D., Wiedemann, P., Lorenz, K., Wasielica-Poslednik, J., Rosbach, J., Dave, H., Wirtz, N., Weber, B., Gelisken, F., Wilhelm, B., Peters, T., Konig, T., Kampik, A., Abbasova, S., Wolf, A., Kurz, S., Herold, T., Arend, N., Dabov, S., Prause, K., Fazekas, C., Martz, J., Bayerl, K., Heuer, U., Bischoff, G., Kunne, C., Lorenz, B., Jager, M., Schiel, H., Datseris, I., Diamanti-Ramza, A., Charonis, A., Straga, I., Babouli, N., Brevetti, C., Tranos, P., Perganta, G., Panayiotis, T., Angeliki, A., Dinioti, T., Tsironi, E., Kotoula, M., Brazitikos, P., Nanas, D., Figueira, J., Ribeiro, L., Molodkina, N., Abdulaeva, E., Pashtaev, N., Ovchinnikova, V., Yurieva, T., Vaycheslav, B., Liya, R., Ahlers, J., Zmatlova, I., Popovcova, M., Bajacek, J., Panisova, J., Struharova, K., Sturova, L., Jamrichova, Z., Krasnik, V., Krajcova, P., Hasa, J., Piovarciova, E., Gajdosova, M., Vida, R., Janco, L., Leskova, V., Demsky, P., Alexik, M., Falatova, A., Lipkova, B., Stubna, M., Tomaskova, D., Herle, D., Martinez Alday, N., Sanchez Aparicio, J. A., Martinez Anton, M., Lopez Galvez, M. I., Manzanas Leal, L., Juberias Sanchez, R., Perez Belmonte, L., Fernandez-Vega Sanz, B., Villota Deleu, E., Gloria, D. L. T. C., Canga, S., De Santiago Rodiguez, M. A., Ramos Gonzalez, D., Prieto Maratin, J. F., Franco Suarez-Barcena, I., Casado Prieto, A., Hernandez Galilea, E., Gomez Ledesma, I., de Juan Marco, L., Mendivil Soto, M. P., Bearan, I., Nunez, M., Lopez Garrido, J. L., Rodriguez Raton, A., Cincunegui, J., Vazquez Cruchaga, E., Quiroga de la Hera, P., Fernandez Rodriguez, M., Rodriguez Cid, M. J., Mendez Martinez, S., Gonzalez Martinez, A., Gomez-Ulla, F., Garcia Garces, I., Martinez Perez, L., Mansilla Cunarro, R., Abraldes Lopez-Veiga, M., Rodriguez Nunez, M., Pineiro Figuera, M. C., Rodriguez Ferro, F., Menon, G., North, L., Chandran, M., Retnamma, R., Sivaprasad, S., Taylor, S., Scanlon, P., Johnston, R., Chong, V., Mall, S., Bailey, C., Varma, D., Talks, J., Lotery, A., Thulasidharan, S., Eckstein, M., Fahd, Q., Koshy, Z., Hanumanthu, S., Kelly, S., Evangelos, S., Ghanchi, F., Asaria, R., Harris, M., Derdeb, T., Dipa, G., and Mahuma, I.

Subjects
Male, Vascular Endothelial Growth Factor A, Time Factors, Visual acuity, genetic structures, Visual Acuity, Angiogenesis Inhibitors, anti‐VEGF, 0302 clinical medicine, Primary outcome, Retrospective Studie, Medicine, Macula Lutea, 030212 general & internal medicine, Fluorescein Angiography, Anti vegf, General Medicine, Middle Aged, ddc, Europe, anti-VEGF, diabetic macular oedema, Intravitreal Injections, Original Article, Female, medicine.symptom, Tomography, Optical Coherence, medicine.drug, Angiogenesis Inhibitor, Human, medicine.medical_specialty, Time Factor, Fundus Oculi, Drug Administration Schedule, Macular Edema, Follow-Up Studie, 03 medical and health sciences, Ophthalmology, Ranibizumab, Humans, In patient, Retrospective Studies, Monitoring, Physiologic, Diabetic Retinopathy, Dose-Response Relationship, Drug, business.industry, Intravitreal Injection, Original Articles, eye diseases, Confidence interval, Diabetic macular oedema, 030221 ophthalmology & optometry, business, Resource utilization, Follow-Up Studies
Abstract

Purpose: Antivascular endothelial growth factor agents are increasingly used in diabetic macular oedema (DME); however, there are few studies exploring their use in DME in real-world settings. Methods: POLARIS was a noninterventional, multicentre study to monitor 12-month outcomes in patients starting ranibizumab treatment in routine practices. The primary outcome was mean change in visual acuity (VA) from baseline to month 12 (last observation carried forward approach). Other outcomes included mean change in central retinal thickness (CRT) and resource utilization. Visual acuity (VA) outcomes were also stratified by country, baseline visual acuity score (VAS), sex, age and injection frequency. Results: Outcomes were analysed from all treated patients (n=804) and from first-year completers (patients who had a visual acuity assessment at 12months; n=568). The mean (SD) baseline VAS was 59.4 (15.9) letters, and the mean change in visual acuity was 4.4 letters (95% confidence interval: 3.3–5.4) at month 12 (study eye; first-year completers). The mean number of injections (study eye) was 4.9, and the mean number of all visits (any eye) was 10 (58% were injection visits) over 12months (first-year completers). The mean (SD) baseline CRT was 410.6 (128.8) μm, and the mean change in CRT was −115.2μm at month 12 (study eye; first-year completers). Visual acuity (VA) outcomes were generally comparable across most countries and subgroups and were greatest in patients with the lowest baseline VAS (≤60 letters). Conclusion: POLARIS showed that real-world outcomes in DME patients starting treatment with ranibizumab were lower than those observed in clinical studies, in spite of extensive monitoring.

Published
2018

6. A noninterventional study to monitor patients with diabetic macular oedema starting treatment with ranibizumab (POLARIS)

Author

Stefanickova, J. Cunha-Vaz, J. Ulbig, M. Pearce, I. Fernández-Vega Sanz, A. Theodossiadis, P. Kodjikian, L. Izmailov, A. Muston, D. Vassilev, Z. Lamotte, B. Tückmantel, C. Friedl, S. Altemark, A. Schwarz, H.-J. Katz, T. Souied, E. Lalloum, F. Querques, G. Ayello-Scheer, S. Coriat, C. Girens, J.F. Sahel, J.-A. Creuzot-Garcher, C. Bremond-Gignac, D. Chiambaretta, F. Farguette, F. Delhay, C. Baillif-Gostoli, S. Maschi, C. Fajnkuchen, F. Milazzo, S. Benzerroug, M. Théron, J.P. Schmickler, S. Zywien, A. Bopp, S. Höh, H. Câmpean, P. Schattmann, K. Fromberg, I. Fromberg, C. Fromberg, D. Spital, G. Heimes, B. Emmerich, K.-H. Lang, M. Krieb, A. Xafis, G. Stock, L. Klotz, N. Ungerechts, R. Matuschek, A. Radermacher, M. Thelen, U. Tetz, M. Denisiuk, M. Berens, U. Schumacher, A. Neuhann, T. Lange, O. Richard, G. Wieland, M. Filev, F. Bittersohl, D. Wiedemann, P. Lorenz, K. Wasielica-Poslednik, J. Rosbach, J. Dave, H. Wirtz, N. Weber, B. Gelisken, F. Wilhelm, B. Peters, T. König, T. Kampik, A. Abbasova, S. Wolf, A. Kurz, S. Herold, T. Arend, N. Dabov, S. Prause, K. Fazekas, C. Märtz, J. Bayerl, K. Heuer, U. Bischoff, G. Künne, C. Lorenz, B. Jäger, M. Schiel, H. Datseris, I. Diamanti-Ramza, A. Charonis, A. Straga, I. Babouli, N. Brevetti, C. Tranos, P. Perganta, G. Panayiotis, T. Angeliki, A. Dinioti, T. Tsironi, E. Kotoula, M. Brazitikos, P. Nanas, D. Figueira, J. Ribeiro, L. Molodkina, N. Abdulaeva, E. Pashtaev, N. Ovchinnikova, V. Yurieva, T. Vaycheslav, B. Liya, R. Ahlers, J. Zmatlova, I. Popovcova, M. Bajacek, J. Panisova, J. Struharova, K. Sturova, L. Jamrichova, Z. Krasnik, V. Krajcova, P. Hasa, J. Piovarciova, E. Gajdosova, M. Vida, R. Janco, L. Leskova, V. Demsky, P. Alexik, M. Falatova, A. Lipkova, B. Stubna, M. Tomaskova, D. Herle, D. Martinez Alday, N. Sanchez Aparicio, J.A. Martinez Anton, M. Lopez Galvez, M.I. Manzanas Leal, L. Juberias Sanchez, R. Perez Belmonte, L. Fernandez-Vega Sanz, B. Villota Deleu, E. Gloria, D.L.T.C. Canga, S. De Santiago Rodiguez, M.A. Ramos Gonzalez, D. Prieto Maratin, J.F. Franco Suarez-Barcena, I. Casado Prieto, A. Hernandez Galilea, E. Gomez Ledesma, I. de Juan Marco, L. Mendivil Soto, M.P. Bearan, I. Nuñez, M. Lopez Garrido, J.L. Rodriguez Raton, A. Cincunegui, J. Vazquez Cruchaga, E. Quiroga de la Hera, P. Fernandez Rodriguez, M. Rodriguez Cid, M.J. Méndez Martínez, S. Gonzalez Martinez, A. Gomez-Ulla, F. Garcia Garcés, I. Martinez Perez, L. Mansilla Cuñarro, R. Abraldes Lopez-Veiga, M. Rodriguez Nuñez, M. Piñeiro Figuera, M.C. Rodriguez Ferro, F. Menon, G. North, L. Chandran, M. Retnamma, R. Sivaprasad, S. Taylor, S. Scanlon, P. Johnston, R. Chong, V. Mall, S. Bailey, C. Varma, D. Talks, J. Lotery, A. Thulasidharan, S. Eckstein, M. Fahd, Q. Koshy, Z. Hanumanthu, S. Kelly, S. Evangelos, S. Ghanchi, F. Asaria, R. Harris, M. Derdeb, T. Dipa, G. Mahuma, I. the POLARIS study investigators

Subjects
genetic structures, eye diseases
Abstract

Purpose: Antivascular endothelial growth factor agents are increasingly used in diabetic macular oedema (DME); however, there are few studies exploring their use in DME in real-world settings. Methods: POLARIS was a noninterventional, multicentre study to monitor 12-month outcomes in patients starting ranibizumab treatment in routine practices. The primary outcome was mean change in visual acuity (VA) from baseline to month 12 (last observation carried forward approach). Other outcomes included mean change in central retinal thickness (CRT) and resource utilization. Visual acuity (VA) outcomes were also stratified by country, baseline visual acuity score (VAS), sex, age and injection frequency. Results: Outcomes were analysed from all treated patients (n = 804) and from first-year completers (patients who had a visual acuity assessment at 12 months; n = 568). The mean (SD) baseline VAS was 59.4 (15.9) letters, and the mean change in visual acuity was 4.4 letters (95% confidence interval: 3.3–5.4) at month 12 (study eye; first-year completers). The mean number of injections (study eye) was 4.9, and the mean number of all visits (any eye) was 10 (58% were injection visits) over 12 months (first-year completers). The mean (SD) baseline CRT was 410.6 (128.8) μm, and the mean change in CRT was −115.2 μm at month 12 (study eye; first-year completers). Visual acuity (VA) outcomes were generally comparable across most countries and subgroups and were greatest in patients with the lowest baseline VAS (≤60 letters). Conclusion: POLARIS showed that real-world outcomes in DME patients starting treatment with ranibizumab were lower than those observed in clinical studies, in spite of extensive monitoring. © 2018 The Authors. Acta Ophthalmologica published by John Wiley & Sons Ltd on behalf of Acta Ophthalmologica Scandinavica Foundation.

Published
2018

8. A noninterventional study to monitor patients with diabetic macular oedema starting treatment with ranibizumab (POLARIS)

Author

Stefanickova, J. Cunha-Vaz, J. Ulbig, M. Pearce, I. Fernández-Vega Sanz, A. Theodossiadis, P. Kodjikian, L. Izmailov, A. Muston, D. Vassilev, Z. Lamotte, B. Tückmantel, C. Friedl, S. Altemark, A. Schwarz, H.-J. Katz, T. Souied, E. Lalloum, F. Querques, G. Ayello-Scheer, S. Coriat, C. Girens, J.F. Sahel, J.-A. Creuzot-Garcher, C. Bremond-Gignac, D. Chiambaretta, F. Farguette, F. Delhay, C. Baillif-Gostoli, S. Maschi, C. Fajnkuchen, F. Milazzo, S. Benzerroug, M. Théron, J.P. Schmickler, S. Zywien, A. Bopp, S. Höh, H. Câmpean, P. Schattmann, K. Fromberg, I. Fromberg, C. Fromberg, D. Spital, G. Heimes, B. Emmerich, K.-H. Lang, M. Krieb, A. Xafis, G. Stock, L. Klotz, N. Ungerechts, R. Matuschek, A. Radermacher, M. Thelen, U. Tetz, M. Denisiuk, M. Berens, U. Schumacher, A. Neuhann, T. Lange, O. Richard, G. Wieland, M. Filev, F. Bittersohl, D. Wiedemann, P. Lorenz, K. Wasielica-Poslednik, J. Rosbach, J. Dave, H. Wirtz, N. Weber, B. Gelisken, F. Wilhelm, B. Peters, T. König, T. Kampik, A. Abbasova, S. Wolf, A. Kurz, S. Herold, T. Arend, N. Dabov, S. Prause, K. Fazekas, C. Märtz, J. Bayerl, K. Heuer, U. Bischoff, G. Künne, C. Lorenz, B. Jäger, M. Schiel, H. Datseris, I. Diamanti-Ramza, A. Charonis, A. Straga, I. Babouli, N. Brevetti, C. Tranos, P. Perganta, G. Panayiotis, T. Angeliki, A. Dinioti, T. Tsironi, E. Kotoula, M. Brazitikos, P. Nanas, D. Figueira, J. Ribeiro, L. Molodkina, N. Abdulaeva, E. Pashtaev, N. Ovchinnikova, V. Yurieva, T. Vaycheslav, B. Liya, R. Ahlers, J. Zmatlova, I. Popovcova, M. Bajacek, J. Panisova, J. Struharova, K. Sturova, L. Jamrichova, Z. Krasnik, V. Krajcova, P. Hasa, J. Piovarciova, E. Gajdosova, M. Vida, R. Janco, L. Leskova, V. Demsky, P. Alexik, M. Falatova, A. Lipkova, B. Stubna, M. Tomaskova, D. Herle, D. Martinez Alday, N. Sanchez Aparicio, J.A. Martinez Anton, M. Lopez Galvez, M.I. Manzanas Leal, L. Juberias Sanchez, R. Perez Belmonte, L. Fernandez-Vega Sanz, B. Villota Deleu, E. Gloria, D.L.T.C. Canga, S. De Santiago Rodiguez, M.A. Ramo and Stefanickova, J. Cunha-Vaz, J. Ulbig, M. Pearce, I. Fernández-Vega Sanz, A. Theodossiadis, P. Kodjikian, L. Izmailov, A. Muston, D. Vassilev, Z. Lamotte, B. Tückmantel, C. Friedl, S. Altemark, A. Schwarz, H.-J. Katz, T. Souied, E. Lalloum, F. Querques, G. Ayello-Scheer, S. Coriat, C. Girens, J.F. Sahel, J.-A. Creuzot-Garcher, C. Bremond-Gignac, D. Chiambaretta, F. Farguette, F. Delhay, C. Baillif-Gostoli, S. Maschi, C. Fajnkuchen, F. Milazzo, S. Benzerroug, M. Théron, J.P. Schmickler, S. Zywien, A. Bopp, S. Höh, H. Câmpean, P. Schattmann, K. Fromberg, I. Fromberg, C. Fromberg, D. Spital, G. Heimes, B. Emmerich, K.-H. Lang, M. Krieb, A. Xafis, G. Stock, L. Klotz, N. Ungerechts, R. Matuschek, A. Radermacher, M. Thelen, U. Tetz, M. Denisiuk, M. Berens, U. Schumacher, A. Neuhann, T. Lange, O. Richard, G. Wieland, M. Filev, F. Bittersohl, D. Wiedemann, P. Lorenz, K. Wasielica-Poslednik, J. Rosbach, J. Dave, H. Wirtz, N. Weber, B. Gelisken, F. Wilhelm, B. Peters, T. König, T. Kampik, A. Abbasova, S. Wolf, A. Kurz, S. Herold, T. Arend, N. Dabov, S. Prause, K. Fazekas, C. Märtz, J. Bayerl, K. Heuer, U. Bischoff, G. Künne, C. Lorenz, B. Jäger, M. Schiel, H. Datseris, I. Diamanti-Ramza, A. Charonis, A. Straga, I. Babouli, N. Brevetti, C. Tranos, P. Perganta, G. Panayiotis, T. Angeliki, A. Dinioti, T. Tsironi, E. Kotoula, M. Brazitikos, P. Nanas, D. Figueira, J. Ribeiro, L. Molodkina, N. Abdulaeva, E. Pashtaev, N. Ovchinnikova, V. Yurieva, T. Vaycheslav, B. Liya, R. Ahlers, J. Zmatlova, I. Popovcova, M. Bajacek, J. Panisova, J. Struharova, K. Sturova, L. Jamrichova, Z. Krasnik, V. Krajcova, P. Hasa, J. Piovarciova, E. Gajdosova, M. Vida, R. Janco, L. Leskova, V. Demsky, P. Alexik, M. Falatova, A. Lipkova, B. Stubna, M. Tomaskova, D. Herle, D. Martinez Alday, N. Sanchez Aparicio, J.A. Martinez Anton, M. Lopez Galvez, M.I. Manzanas Leal, L. Juberias Sanchez, R. Perez Belmonte, L. Fernandez-Vega Sanz, B. Villota Deleu, E. Gloria, D.L.T.C. Canga, S. De Santiago Rodiguez, M.A. Ramo

Published
2018

9. Strategy for the management of uncomplicated retinal detachments: the European vitreo-retinal society retinal detachment study report 1

Author

BENMERZOUGA N, METTI F, RAZZARI A, MIESBAUER P, SCHÖNHERR U, ZEYNALOVA Z, BASHIR SJ, JACOB J, KOCH P, LADHA R, SMETS E, STALMANS P, DARE A, DEVENYI R, LAM WC, SHAHEEDA M, POTAMITIS T, CHRISTENSEN SR, RAYES E, MORTADA H, SHOUMAN A, HOLM M, ALBINET P, AMAR JP, BECQUET F, BERROD JP, BOULZE M, BOSCHER C, COURJARET JC, DENION E, FOURMAUX, E, GUIGOU S, HAMON F, LAFONTAINE PO, LE ROUIC JF, LEYNAUD JL, NOCHEZ Y, PERONE JM, RYSANEK B, SOYEUR R, BOPP S, BRIX A, HÖHN F, KUSSEROW C, LUCKE K, MOHR A, SCHÜLER A, WEINBERGER A, GOTZARIDIS S, KARATZENIS D, STEFANIOTOU M, K. TSILIMBARIS MK, TSOURIS D, TSANG CW, GABOR R, SZIJARTO Z, BABU N, BANKER AS, BAPAYE M, KELKAR A, ENTEZARI, M, FATEH MOGHADAM HF, RAMEZANI A, SAFARPOUR LIMA B, OMER K, BOSCIA F, CHIARA FRENO M, CIAN R, DONVITO G, FACINO M, LESNONI G, LIUZZI, F, METE M, MININNI F, MOCHI B, PRIMAVERA V, PERTILE G, TURCO I, VASTARELLA P, FONG K, LEE M, VP LOO A, ARAGON HARRISON O, FLORES AGUILAR M, LOPEZ MONTERO LM, LOPEZCARASA HERNANDEZ G, VELASCO I, BOEYDEN V, BOSSCHA M, DE VRIES KNOPPERT W, LINDSTEDT, E. RENARDEL DE LAVALETTE VW, VAN DEN BIESEN PR, ALHASSAN M, BAERLAND TP, BOBER AM, FORSAA V, FOSSEN K, VARHAUG P, ATIENZA J.r. NF, CISIECKI S, FRYCZKOWSKI P, KOWAL LANGE A, MICHALEWSKA Z, MICHALEWSKI J, NAWROCKI J, NOWOSIELSKA A, ODROBINA D, PIETRAS TRZPIEL M, ZAKRZEWSKA A, MEIRELES A, TEIXEIRA S, ELSHAFEI M, DANIELESCU C, TALU S, ALTYNBAEV U, GORIN A, SEREJINE I, EL DEEB M, DAVIDOVIC S, IGNJATOVIC Z, STEFANICKOVA J, VENTER L, CHANG W, JO YL, KIM JY, LEE J, LIM ST, SAGONG M, ASCASO FJ, CASTRO J, CORDOVES L. DESCO ESTEBAN C, MORENO MANRESA J, VILAPLANA D, JANIEC S, TOMIC Z, BEN YAHIA S, ACAR N, GÜNGEL H, KAPRAN Z, OSMANBASOGLU O, OZDEK S, TOPBAS S, TOTAN Y, ÜNVER YB, CHICHUR D, DOBROVOLSKEY O, KOZLOVSKA I, LYTVYNCHUK L, PHYLYPCHUK O, POSTOLOVSKA A, SERGIIENKO A, SHEVCHYK V, WINDER S, CULOTTA J, KIM S, KING J, KURUP SK, LIN SJ, PACURARIU R, ROTH D, SINCLAIR S, WEBER P, DOAN H, TUNG T., ROMANO, MARIO, Benmerzouga, N, Metti, F, Razzari, A, Miesbauer, P, Schönherr, U, Zeynalova, Z, Bashir, Sj, Jacob, J, Koch, P, Ladha, R, Smets, E, Stalmans, P, Dare, A, Devenyi, R, Lam, Wc, Shaheeda, M, Potamitis, T, Christensen, Sr, Rayes, E, Mortada, H, Shouman, A, Holm, M, Albinet, P, Amar, Jp, Becquet, F, Berrod, Jp, Boulze, M, Boscher, C, Courjaret, Jc, Denion, E, Fourmaux, E, Guigou, S, Hamon, F, Lafontaine, Po, LE ROUIC, Jf, Leynaud, Jl, Nochez, Y, Perone, Jm, Rysanek, B, Soyeur, R, Bopp, S, Brix, A, Höhn, F, Kusserow, C, Lucke, K, Mohr, A, Schüler, A, Weinberger, A, Gotzaridis, S, Karatzenis, D, Stefaniotou, M, K., TSILIMBARIS MK, Tsouris, D, Tsang, Cw, Gabor, R, Szijarto, Z, Babu, N, Banker, A, Bapaye, M, Kelkar, A, Entezari, M, FATEH MOGHADAM, Hf, Ramezani, A, SAFARPOUR LIMA, B, Omer, K, Boscia, F, CHIARA FRENO, M, Cian, R, Donvito, G, Facino, M, Lesnoni, G, Liuzzi, F, Mete, M, Mininni, F, Mochi, B, Primavera, V, Romano, Mario, Pertile, G, Turco, I, Vastarella, P, Fong, K, Lee, M, VP LOO, A, ARAGON HARRISON, O, FLORES AGUILAR, M, LOPEZ MONTERO, Lm, LOPEZCARASA HERNANDEZ, G, Velasco, I, Boeyden, V, Bosscha, M, DE VRIES KNOPPERT, W, Lindstedt, E., RENARDEL DE LAVALETTE VW, VAN DEN BIESEN, Pr, Alhassan, M, Baerland, Tp, Bober, Am, Forsaa, V, Fossen, K, Varhaug, P, ATIENZA J. r., Nf, Cisiecki, S, Fryczkowski, P, KOWAL LANGE, A, Michalewska, Z, Michalewski, J, Nawrocki, J, Nowosielska, A, Odrobina, D, PIETRAS TRZPIEL, M, Zakrzewska, A, Meireles, A, Teixeira, S, Elshafei, M, Danielescu, C, Talu, S, Altynbaev, U, Gorin, A, Serejine, I, EL DEEB, M, Davidovic, S, Ignjatovic, Z, Stefanickova, J, Venter, L, Chang, W, Jo, Yl, Kim, Jy, Lee, J, Lim, St, Sagong, M, Ascaso, Fj, Castro, J, CORDOVES L., DESCO ESTEBAN C, MORENO MANRESA, J, Vilaplana, D, Janiec, S, Tomic, Z, BEN YAHIA, S, Acar, N, Güngel, H, Kapran, Z, Osmanbasoglu, O, Ozdek, S, Topbas, S, Totan, Y, Ünver, Yb, Chichur, D, Dobrovolskey, O, Kozlovska, I, Lytvynchuk, L, Phylypchuk, O, Postolovska, A, Sergiienko, A, Shevchyk, V, Winder, S, Culotta, J, Kim, S, King, J, Kurup, Sk, Lin, Sj, Pacurariu, R, Roth, D, Sinclair, S, Weber, P, Doan, H, and Tung, T.

Abstract

OBJECTIVE: To study success and failure in the treatment of uncomplicated rhegmatogenous retinal detachments (RRDs). DESIGN: Nonrandomized, multicenter retrospective study. PARTICIPANTS: One hundred seventy-six surgeons from 48 countries spanning 5 continents provided information on the primary procedures for 7678 cases of RRDs including 4179 patients with uncomplicated RRDs. METHODS: Reported data included specific clinical findings, the method of repair, and the outcome after intervention. MAIN OUTCOME MEASURES: Final failure of retinal detachment repair (level 1 failure rate), remaining silicone oil at the study's conclusion (level 2 failure rate), and need for additional procedures to repair the detachment (level 3 failure rate). RESULTS: Four thousand one hundred seventy-nine uncomplicated cases of RRD were included. Combining phakic, pseudophakic, and aphakic groups, those treated with scleral buckle alone (n = 1341) had a significantly lower final failure rate than those treated with vitrectomy, with or without a supplemental buckle (n = 2723; P = 0.04). In phakic patients, final failure rate was lower in the scleral buckle group compared with those who had vitrectomy, with or without a supplemental buckle (P = 0.028). In pseudophakic patients, the failure rate of the initial procedure was lower in the vitrectomy group compared with the scleral buckle group (P = 3×10(-8)). There was no statistically significant difference in failure rate between segmental (n = 721) and encircling (n = 351) buckles (P = 0.5). Those who underwent vitrectomy with a supplemental scleral buckle (n = 488) had an increased failure rate compared with those who underwent vitrectomy alone (n = 2235; P = 0.048). Pneumatic retinopexy was found to be comparable with scleral buckle when a retinal hole was present (P = 0.65), but not in cases with a flap tear (P = 0.034). CONCLUSIONS: In the treatment of uncomplicated phakic retinal detachments, repair using scleral buckle may be a good option. There was no significant difference between segmental versus 360-degree buckle. For pseudophakic uncomplicated retinal detachments, the surgeon should balance the risks and benefits of vitrectomy versus scleral buckle and keep in mind that the single-surgery reattachment rate may be higher with vitrectomy. However, if a vitrectomy is to be performed, these data suggest that a supplemental buckle is not helpful.

Published
2013

10. Strategy for the management of complex retinal detachments: the European vitreo-retinal society retinal detachment study report 2

Author

BENMERZOUGA N, METTI F, RAZZARI A, MIESBAUER P, SCHÖNHERR U, ZEYNALOVA Z, BASHIR SJ, JACOB J, KOCH P, LADHA R, SMETS E, STALMANS P, DARE A, DEVENYI R, LAM WC, SHAHEEDA M, POTAMITIS T, CHRISTENSEN SR, RAYES E, MORTADA H, SHOUMAN A, HOLM M, ALBINET P, AMAR JP, BECQUET F, BERROD JP, BOULZE M, BOSCHER C, COURJARET JC, DENION E, FOURMAUX, E, GUIGOU S, HAMON F, LAFONTAINE PO, LE ROUIC JF, LEYNAUD JL, NOCHEZ Y, PERONE JM, RYSANEK B, SOYEUR R, BOPP S, BRIX A, HÖHN F, KUSSEROW C, LUCKE K, MOHR A, SCHÜLER A, WEINBERGER A, GOTZARIDIS S, KARATZENIS D, STEFANIOTOU M, K. TSILIMBARIS MK, TSOURIS D, TSANG CW, GABOR R, SZIJARTO Z, BABU N, BANKER AS, BAPAYE M, KELKAR A, ENTEZARI, M, FATEH MOGHADAM HF, RAMEZANI A, SAFARPOUR LIMA B, OMER K, BOSCIA F, CHIARA FRENO M, CIAN R, DONVITO G, FACINO M, LESNONI G, LIUZZI, F, METE M, MININNI F, MOCHI B, PRIMAVERA V, PERTILE G, TURCO I, VASTARELLA P, FONG K, LEE M, VP LOO A, ARAGON HARRISON O, FLORES AGUILAR M, LOPEZ MONTERO LM, LOPEZCARASA HERNANDEZ G, VELASCO I, BOEYDEN V, BOSSCHA M, DE VRIES KNOPPERT W, LINDSTEDT, E. RENARDEL DE LAVALETTE VW, VAN DEN BIESEN PR, ALHASSAN M, BAERLAND TP, BOBER AM, FORSAA V, FOSSEN K, VARHAUG P, ATIENZA J.r. NF, CISIECKI S, FRYCZKOWSKI P, KOWAL LANGE A, MICHALEWSKA Z, MICHALEWSKI J, NAWROCKI J, NOWOSIELSKA A, ODROBINA D, PIETRAS TRZPIEL M, ZAKRZEWSKA A, MEIRELES A, TEIXEIRA S, ELSHAFEI M, DANIELESCU C, TALU S, ALTYNBAEV U, GORIN A, SEREJINE I, EL DEEB M, DAVIDOVIC S, IGNJATOVIC Z, STEFANICKOVA J, VENTER L, CHANG W, JO YL, KIM JY, LEE J, LIM ST, SAGONG M, ASCASO FJ, CASTRO J, CORDOVES L. DESCO ESTEBAN C, MORENO MANRESA J, VILAPLANA D, JANIEC S, TOMIC Z, BEN YAHIA S, ACAR N, GÜNGEL H, KAPRAN Z, OSMANBASOGLU O, OZDEK S, TOPBAS S, TOTAN Y, ÜNVER YB, CHICHUR D, DOBROVOLSKEY O, KOZLOVSKA I, LYTVYNCHUK L, PHYLYPCHUK O, POSTOLOVSKA A, SERGIIENKO A, SHEVCHYK V, WINDER S, CULOTTA J, KIM S, KING J, KURUP SK, LIN SJ, PACURARIU R, ROTH D, SINCLAIR S, WEBER P, DOAN H, TUNG T., ROMANO, MARIO, Benmerzouga, N, Metti, F, Razzari, A, Miesbauer, P, Schönherr, U, Zeynalova, Z, Bashir, Sj, Jacob, J, Koch, P, Ladha, R, Smets, E, Stalmans, P, Dare, A, Devenyi, R, Lam, Wc, Shaheeda, M, Potamitis, T, Christensen, Sr, Rayes, E, Mortada, H, Shouman, A, Holm, M, Albinet, P, Amar, Jp, Becquet, F, Berrod, Jp, Boulze, M, Boscher, C, Courjaret, Jc, Denion, E, Fourmaux, E, Guigou, S, Hamon, F, Lafontaine, Po, LE ROUIC, Jf, Leynaud, Jl, Nochez, Y, Perone, Jm, Rysanek, B, Soyeur, R, Bopp, S, Brix, A, Höhn, F, Kusserow, C, Lucke, K, Mohr, A, Schüler, A, Weinberger, A, Gotzaridis, S, Karatzenis, D, Stefaniotou, M, K., TSILIMBARIS MK, Tsouris, D, Tsang, Cw, Gabor, R, Szijarto, Z, Babu, N, Banker, A, Bapaye, M, Kelkar, A, Entezari, M, FATEH MOGHADAM, Hf, Ramezani, A, SAFARPOUR LIMA, B, Omer, K, Boscia, F, CHIARA FRENO, M, Cian, R, Donvito, G, Facino, M, Lesnoni, G, Liuzzi, F, Mete, M, Mininni, F, Mochi, B, Primavera, V, Romano, Mario, Pertile, G, Turco, I, Vastarella, P, Fong, K, Lee, M, VP LOO, A, ARAGON HARRISON, O, FLORES AGUILAR, M, LOPEZ MONTERO, Lm, LOPEZCARASA HERNANDEZ, G, Velasco, I, Boeyden, V, Bosscha, M, DE VRIES KNOPPERT, W, Lindstedt, E., RENARDEL DE LAVALETTE VW, VAN DEN BIESEN, Pr, Alhassan, M, Baerland, Tp, Bober, Am, Forsaa, V, Fossen, K, Varhaug, P, ATIENZA J. r., Nf, Cisiecki, S, Fryczkowski, P, KOWAL LANGE, A, Michalewska, Z, Michalewski, J, Nawrocki, J, Nowosielska, A, Odrobina, D, PIETRAS TRZPIEL, M, Zakrzewska, A, Meireles, A, Teixeira, S, Elshafei, M, Danielescu, C, Talu, S, Altynbaev, U, Gorin, A, Serejine, I, EL DEEB, M, Davidovic, S, Ignjatovic, Z, Stefanickova, J, Venter, L, Chang, W, Jo, Yl, Kim, Jy, Lee, J, Lim, St, Sagong, M, Ascaso, Fj, Castro, J, CORDOVES L., DESCO ESTEBAN C, MORENO MANRESA, J, Vilaplana, D, Janiec, S, Tomic, Z, BEN YAHIA, S, Acar, N, Güngel, H, Kapran, Z, Osmanbasoglu, O, Ozdek, S, Topbas, S, Totan, Y, Ünver, Yb, Chichur, D, Dobrovolskey, O, Kozlovska, I, Lytvynchuk, L, Phylypchuk, O, Postolovska, A, Sergiienko, A, Shevchyk, V, Winder, S, Culotta, J, Kim, S, King, J, Kurup, Sk, Lin, Sj, Pacurariu, R, Roth, D, Sinclair, S, Weber, P, Doan, H, and Tung, T.

Abstract

OBJECTIVE: To study the outcome of the treatment of complex rhegmatogenous retinal detachments (RRDs). DESIGN: Nonrandomized, multicenter, retrospective study. PARTICIPANTS: One hundred seventy-six surgeons from 48 countries spanning 5 continents reported primary procedures for 7678 RRDs. METHODS: Reported data included clinical manifestations, the method of repair, and the outcome. MAIN OUTCOME MEASURES: Failure of retinal detachment repair (level 1 failure rate), remaining silicone oil at the study's conclusion (level 2 failure rate), and need for additional procedures to repair the detachments (level 3 failure rate). RESULTS: The main categories of complex retinal detachments evaluated in this investigation were: (1) grade B proliferative vitreoretinopathy (PVR; n = 917), (2) grade C-1 PVR (n = 637), (3) choroidal detachment or significant hypotony (n = 578), (4) large or giant retinal tears (n = 1167), and (5) macular holes (n = 153). In grade B PVR, the level 1 failure rate was higher when treated with a scleral buckle alone versus vitrectomy (P = 0.0017). In grade C-1 PVR, there was no statistically significant difference in the level 1 failure rate between those treated with vitrectomy, with or without scleral buckle, and those treated with scleral buckle alone (P = 0.7). Vitrectomy with a supplemental buckle had an increased failure rate compared with those who did not receive a buckle (P = 0.007). There was no statistically significant difference in level 1 failure rate between tamponade with gas versus silicone oil in patients with grade B or C-1 PVR. Cases with choroidal detachment or hypotony treated with vitrectomy had a significantly lower failure rate versus treatment with scleral buckle alone (P = 0.0015). Large or giant retinal tears treated with vitrectomy also had a significantly lower failure rate versus treatment with scleral buckle (P = 7×10(-8)). CONCLUSIONS: In patients with retinal detachment, when choroidal detachment, hypotony, a large tear, or a giant tear is present, vitrectomy is the procedure of choice. In retinal detachments with PVR, tamponade with either gas or silicone oil can be considered. If a vitrectomy is to be performed, these data suggest that a supplemental buckle may not be helpful. FINANCIAL DISCLOSURE(S): The author(s) have no proprietary or commercial interest in any materials discussed in this article.

Published
2013

11. Understanding Loss to Follow-Up in AMD Patients Receiving VEGF Inhibitor Therapy: Associated Factors and Underlying Reasons.

Author

Kusenda P, Caprnda M, Gabrielova Z, Kukova N, Pavlovic S, and Stefanickova J

Abstract

Background: In patients with wet age-related macular degeneration (AMD), loss to follow-up (LTFU) leads to unplanned interruptions in therapy and the risk of visual loss., Methods: This retrospective and prospective case-control cohort study compared AMD patients with (LTFU YES) and without (LTFU NO) LTFU during anti-VEGF treatment over 12 years. LTFU was defined as missing any treatment or monitoring visits, or not scheduling follow-ups for six months., Results: Significant differences between LTFU NO ( n = 298) and LTFU YES ( n = 174) groups were age, treatment phase, baseline and final best-corrected visual acuity (BCVA), type of anti-VEGF drug, treatment switch, commuting distance, and escort during commuting. A multivariate logistic regression analysis identified the need for an escort during the commuting and treatment phase as the only significant difference. The four most common reasons for LTFU were general health worsening (21.8%), patient-missed appointments (16.7%), COVID-19-related issues (14.9%), and treatment dissatisfaction (8.6%)., Conclusions: The factors associated with increased LTFU rates were older age, inactive treatment phase, lower baseline and final BCVA, bevacizumab treatment, monotherapy, longer travelling distance, and commuting with an escort. According to the multivariate logistic regression analysis, only the escort during the commuting and treatment phases was significant. These findings could direct research to explore social support in treatment adherence and highlight the importance of treatment phases in practice.

Published
2024
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12. Efficacy and Safety of Brolucizumab for Diabetic Macular Edema: The KINGFISHER Randomized Clinical Trial.

Author

Singh RP, Barakat MR, Ip MS, Wykoff CC, Eichenbaum DA, Joshi S, Warrow D, Sheth VS, Stefanickova J, Kim YS, He F, Cho GE, Wang Y, and Emanuelli A

Subjects
Humans, Male, Middle Aged, Female, Angiogenesis Inhibitors adverse effects, Vascular Endothelial Growth Factor A, Receptors, Vascular Endothelial Growth Factor therapeutic use, Intravitreal Injections, Recombinant Fusion Proteins therapeutic use, Treatment Outcome, Macular Edema diagnosis, Macular Edema drug therapy, Macular Edema etiology, Diabetic Retinopathy diagnosis, Diabetic Retinopathy drug therapy, Diabetic Retinopathy complications, Diabetes Mellitus drug therapy
Abstract

Importance: Despite the effectiveness of existing anti-vascular endothelial growth factor (VEGF) therapies, a need remains for further treatment options to improve response rates and/or reduce injection or monitoring frequency in patients with diabetic macular edema (DME)., Objective: To evaluate the efficacy and safety of brolucizumab vs aflibercept dosed every 4 weeks in participants with DME., Design, Participants, and Setting: This 52-week, double-masked, phase 3 randomized clinical trial included treatment-naive adults and adults who had previously received anti-VEGF therapy. Data were collected from September 2019 to March 2020, and data were analyzed from April 2020 to February 2021., Intervention: Brolucizumab, 6 mg, intravitreal injection every 4 weeks or aflibercept, 2 mg, intravitreal injection every 4 weeks., Main Outcomes and Measures: Participants were randomized 2:1 to brolucizumab, 6 mg, or aflibercept, 2 mg. The primary end point was change from baseline in best-corrected visual acuity at week 52. Secondary end points were the proportion of participants with a 2-step improvement or greater from baseline in Diabetic Retinopathy Severity Scale score, the proportion of eyes with absence of both subretinal fluid and intraretinal fluid, change from baseline in central subfield thickness, and safety at week 52., Results: A total of 517 participants were randomized to brolucizumab (n = 346) or aflibercept (n = 171); 299 (57.8%) were male, and the mean (SD) age was 60.7 (10.2) years. Brolucizumab was noninferior to aflibercept in best-corrected visual acuity (Early Treatment Diabetic Retinopathy Study letter score) change from baseline at week 52 (brolucizumab, 12.2-letter improvement; aflibercept, 11.0-letter improvement; difference, 1.1; 95% CI, -0.6 to 2.9; noninferiority margin, 4; P < .001). Brolucizumab was superior to aflibercept for the proportion of eyes without subretinal and intraretinal fluid (brolucizumab, 144 of 346 [41.6%]; aflibercept, 38 of 171 [22.2%]; difference, 20.0%; 95% CI, 12.5to 28.6; P < .001) and mean central subfield thickness change from baseline at week 52 (brolucizumab, -237.8 μm; aflibercept, -196.5 μm; difference, -41.4; 95% CI, -58.9 to -23.8; P < .001). Incidence of intraocular inflammation was 4.0% (14 of 346) in the brolucizumab arm and 2.9% (5 of 171) in the aflibercept arm, incidence of retinal vasculitis was 0.9% (3 of 346) and 0.6% (1 of 171), respectively, and incidence of retinal vascular occlusion was 0.3% (1 of 346) and 0.6% (1 of 171). One participant in the brolucizumab arm had retinal artery occlusion., Conclusions and Relevance: In these study participants with DME, no clinically meaningful differences in visual outcomes were noted between the brolucizumab and aflibercept arms; some superior anatomic improvements were noted in the brolucizumab arm. No new safety concerns were identified., Trial Registration: ClinicalTrials.gov Identifier: NCT03917472.

Published
2023
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13. Higher Levels of Serum Ionic Calcium are Associated with Macular Edema in Patients with Diabetic Retinopathy.

Author

Ankita, Saxena S, Ahmad MK, Nim DK, Mahdi AA, Kaur A, Bhasker SK, Vesely P, Stefanickova J, Rodrigo L, Kruzliak P, and Krasnik V

Subjects
Calcium, Cross-Sectional Studies, Humans, Tomography, Optical Coherence, Diabetes Mellitus, Diabetic Retinopathy diagnosis, Macular Edema diagnosis
Abstract

Background: The aim was to study the association of serum total calcium, ionic calcium, and magnesium with increases in macular thickness parameters and photoreceptor ellipsoid zone (EZ) disruption in diabetic macular edema (DME)., Methods: This study is a tertiary care center based observational cross-sectional study with sixty-six consecutive cases, divided into 3 groups of 22 cases each with no diabetic retinopathy (No DR), non-proliferative diabetic retinopathy (NPDR), and proliferative diabetic retinopathy (PDR) and a control group of 22 healthy controls. Best corrected visual acuity (BCVA) was measured on logMAR scale. Central subfield thickness (CST), cube average thickness (CAT), and EZ disruption were assessed using spectral-domain optical coherence tomography (SD-OCT). Serum total calcium, ionic calcium, and magnesium were measured using standard protocol. Data was analyzed statistically., Results: Significant correlation was found between the increase in CST and the increase in serum total calcium and serum ionic calcium. Increase in CAT was significantly correlated with an increase in serum total calcium, serum ionic calcium, and a decrease in serum magnesium. Grades of EZ disruption and logMAR BCVA were also found to be significantly positively associated with serum total calcium and ionic calcium and negatively with serum magnesium., Conclusions: Increased levels of serum ionic calcium and decreased levels of serum magnesium are associated with an increase in macular thickness and EZ disruption in DME.

Published
2022
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14. Analysis of biometric parameters of 2340 eyes measured with optical biometer Lenstar LS900 in a Caucasian population.

Author

Popov I, Waczulikova I, Stefanickova J, Valaskova J, Tomcikova D, Shiwani HA, Delev D, Rodrigo L, Saxena S, Kruzliak P, and Krasnik V

Subjects
Aged, Anterior Chamber, Axial Length, Eye, Biometry, Cornea, Female, Humans, Male, Retrospective Studies, Tomography, Optical Coherence, Cataract diagnosis, Lens, Crystalline
Abstract

Objectives: To describe the pattern and mutual relationships between basic biometric characteristics of the eye in a Central European Caucasian population., Methods: A single-centre retrospective study of 2340 patients (965 males, 1375 females) scheduled for cataract surgery between 2014 and 2016. Measurements using laser interferometry included AL (axial length), K (average corneal curvature), ACD (anterior chamber depth), LT (lens thickness), CCT (central corneal thickness), AST (astigmatism) and WTW (white to white). Subjects were stratified by gender and controlled for age. Descriptive, correlation and regression analyses were performed on the data., Results: The mean AL was 23.33 ± 1.01 mm - higher in males (23.59 ± 0.99 mm), in comparison to females (23.15 ± 0.99 mm). The elderly had lower ACD and higher LT, while males had higher AL independent of age. Furthermore, LT and K decreased with AL, while ACD decreased with LT and increased with AL independent of age and gender., Conclusions: The estimates of the biometrics are obtained on a large sample of subjects and can serve as normative values for Lenstar LS900 in the Central European Caucasian population.

Published
2022
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15. Effect of Blue Light Filtering Intraocular Lenses on Visual Perception.

Author

Popov I, Jurenova D, Valaskova J, Sanchez-Chicharro D, Stefanickova J, Waczulikova I, and Krasnik V

Subjects
Case-Control Studies, Contrast Sensitivity, Humans, Lens Implantation, Intraocular, Retrospective Studies, Visual Acuity, Lenses, Intraocular, Phacoemulsification
Abstract

Background and Objectives: This retrospective consecutive case control study compares best-corrected visual acuity (BCVA), mesopic contrast sensitivity (CS), color vision, and glare between a group of eyes with blue-light-filtering intraocular lenses and another with UV-light-filtering intraocular lenses. Materials and Methods: We used Early Treatment Diabetic Retinopathy Study charts to compare BCVA, Rabin charts for mesopic CS testing, Oculus HMC Anomaloscope MR to test for chromatic discrimination, and Oculus Mesotest II to measure scotopic CS with glare. For analysis, we used descriptive statistics and compared means with parametric and non-parametric tests. The level of significance was set as α = 0.05. Results: For the group with the blue-light-filtering intraocular lens, the average results were BCVA = 0.96 (SD ± 0.09), CS = 1.78 log (SD ± 0.12), chromatic discrimination results M = 63.91 (SD ± 11.88), R = 60.07 (SD ± 7.89). For mesopic CS with glare, the group achieved on average 2.54 (SD ± 1.50) points out of 4. For the group with the UV-light-filtering intraocular lens, the average results were BCVA = 0.93 (SD ± 0.14), CS = 1.79 log (SD ± 0.13), chromatic discrimination results M = 65.38 (SD ± 17.14), R = 60.79 (SD ± 10.39). For mesopic CS with glare, this group achieved an average of 2.79 (SD ± 1.53) points out of 4. Conclusion: No significant differences ( p > 0.05) were found in any of the tested parameters between the analyzed groups. Slight shift in color vision was observed, although not statistically significant.

Published
2021
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16. Hyperglycemia potentiates the effect of ionic calcium in photoreceptor ellipsoid zone disruption in diabetic retinopathy.

Author

Ankita, Stefanickova J, Saxena S, Nim DK, Ahmad K, Mahdi AA, Kaur A, Bhasker SK, Valaskova J, and Kruzliak P

Subjects
Adult, Aged, Analysis of Variance, Case-Control Studies, Cross-Sectional Studies, Female, Glycated Hemoglobin analysis, Humans, Male, Middle Aged, Calcium blood, Diabetic Retinopathy physiopathology, Hyperglycemia physiopathology, Photoreceptor Cells, Vertebrate pathology
Abstract

Purpose: To study the association of serum ionic calcium and glycated hemoglobin (HbA1c) with retinal photoreceptor ellipsoid zone (EZ) disruption in diabetic retinopathy (DR)., Methods: This is a tertiary care center-based observational cross-sectional study. Sixty-three consecutive cases, divided into 21 cases each with no diabetic retinopathy, non-proliferative diabetic retinopathy and proliferative diabetic retinopathy were included. Twenty-one healthy controls were also included. Ellipsoid zone disruption was assessed using spectral-domain optical coherence tomography. Serum ionic calcium and HbA1c were measured using standard protocol. Patient data from cases were divided into two groups according to their HbA1c levels: group 1 (HbA1c < 7, n = 26) and group 2 (HbA1c > 7, n = 37). Data were analyzed statistically., Results: Mean ionic calcium levels in group 1 and group 2 were 1.131 ± 0.073 mmol/dL and 1.170 ± 0.070 mmol/dL, respectively. In group 1, 11 out of 26 had EZ disruption (42.3%). Similarly, in group 2, 29 out of 37 had EZ disruption (78.4%). On logistic regression analysis, as compared to group 1, ellipsoid zone disruption was found to be positively associated with serum ionic calcium (p = 0.01) in group 2 cases., Conclusion: Increased levels of serum ionic calcium are associated with increased EZ disruption in patients with HbA1c > 7 in DR.

Published
2019
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17. Disorganization of retinal inner layers correlates with ellipsoid zone disruption and retinal nerve fiber layer thinning in diabetic retinopathy.

Author

Nadri G, Saxena S, Stefanickova J, Ziak P, Benacka J, Gilhotra JS, and Kruzliak P

Subjects
Cross-Sectional Studies, Diabetic Retinopathy physiopathology, Female, Humans, Macula Lutea pathology, Male, Middle Aged, Retina physiopathology, Tomography, Optical Coherence, Visual Acuity, Diabetes Mellitus, Type 2 complications, Diabetic Retinopathy pathology, Nerve Fibers physiology, Retina pathology
Abstract

Purpose: To study the correlation between disorganization of inner retinal layer (DRIL) and macular thickness parameters, ellipsoid zone (EZ) disruption and retinal nerve fiber layer (RNFL) thickness on spectral domain optical coherence tomography (SD-OCT) in diabetic retinopathy (DR), for the first time., Methods: A tertiary care center-based cross-sectional study was undertaken. One hundred and four consecutive study subjects of type 2 diabetes mellitus were included: diabetes mellitus with no retinopathy (No DR) (n = 26); non-proliferative DR (NPDR) (n = 26); proliferative DR (PDR) (n = 26) and healthy controls (n = 26). Best Corrected Visual Acuity (BCVA) was measured on the logarithm of the minimum angle of resolution (logMAR) scale. Clinician-friendly, SD-OCT based, grading systems were created for DRIL and EZ disruption, within the macular cube. DRIL was graded as: grade 0, DRIL absent; and grade 1, DRIL present. EZ disruption was graded as; Grade 0: Intact EZ; Grade 1: Focal disruption and Grade 2: Global disruption. Every study subject underwent RNFL thickness analysis., Results: DRIL was significantly associated with increase in severity of DR.Pearson correlation analysis showed significant positive correlation between DRIL and CST CAT and grades of EZ disruption . However, a significant negative correlation was found between DRIL and RNFL thickness ., Conclusion: Presence of DRIL correlates with severity of DR, EZ disruption and RNFL thinning., (Copyright © 2019 Elsevier Inc. All rights reserved.)

Published
2019
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18. Vision-Related Quality of Life in Patients with Diabetic Macular Edema Treated with Intravitreal Aflibercept: The AQUA Study.

Author

Garweg JG, Stefanickova J, Hoyng C, Schmelter T, Niesen T, Sowade O, and Sivaprasad S

Subjects
Aged, Diabetes Mellitus, Type 1 complications, Diabetes Mellitus, Type 2 complications, Diabetic Retinopathy diagnosis, Diabetic Retinopathy drug therapy, Female, Humans, Intravitreal Injections, Macular Edema diagnosis, Macular Edema drug therapy, Male, Middle Aged, Sickness Impact Profile, Single-Blind Method, Surveys and Questionnaires, Tomography, Optical Coherence, Vascular Endothelial Growth Factor A antagonists & inhibitors, Visual Acuity physiology, Angiogenesis Inhibitors therapeutic use, Diabetic Retinopathy psychology, Macular Edema psychology, Quality of Life psychology, Receptors, Vascular Endothelial Growth Factor therapeutic use, Recombinant Fusion Proteins therapeutic use, Vision, Ocular physiology
Abstract

Purpose: To examine vision-related quality of life in patients with diabetic macular edema (DME) treated with intravitreal aflibercept (EYLEA, Regeneron Pharmaceuticals, Inc, Tarrytown, NY)., Design: AQUA was a multicenter, open-label, single-arm, phase 4 study., Participants: Adults 18 years of age or older with type 1 or 2 diabetes mellitus and DME., Methods: Patients received intravitreal aflibercept 2 mg every 8 weeks for 52 weeks, after 5 initial doses every 4 weeks., Main Outcome Measures: The primary outcome was the change in 25-item National Eye Institute Visual Function Questionnaire (NEI VFQ-25) total score from baseline to week 52. Secondary outcomes included the change in NEI VFQ-25 near and distant activities subscale scores, best-corrected visual acuity (BCVA; Early Treatment Diabetic Retinopathy Study [ETDRS] letters), and central retinal thickness (CRT) from baseline to week 52. Change in NEI VFQ-25 score at week 52 for better-seeing eyes (BSEs) and worse-seeing eyes (WSEs) also was evaluated., Results: A total of 553 patients comprised the full analysis set, and 560 patients comprised the safety analysis set. At baseline, the mean NEI VFQ-25 total score was 70.12, mean BCVA was 61.5 ETDRS letters, and mean CRT was 464.81 μm. A mean of 8.8 injections were administered over 52 weeks. At week 52, the mean improvement from baseline in the NEI VFQ-25 total score was +6.11 (standard deviation [SD], 11.46); the corresponding improvements in near and distant activities were +11.37 (SD, 18.01) and +7.33 (SD, 17.32), respectively. Similarly, improvements in patients whose BSE and WSE were treated were 7.74 (SD, 13.59) and 5.48 (SD, 9.70), respectively. At week 52, mean change in BCVA was +10.0 ETDRS letters (SD, 8.0 ETDRS letters), and mean change in CRT was -175.38 μm (SD, 132.62 μm). Overall, 53.6% of patients reported treatment-emergent adverse events (TEAEs), of whom 26.8% experienced an ocular TEAE in the study eye. The most common serious ocular TEAE was endophthalmitis (0.5% [n = 3]). Five deaths (0.9%) were reported, but were not considered treatment related., Conclusions: Intravitreal aflibercept was associated with clinically meaningful improvements in NEI VFQ-25 total score over 52 weeks in patients with DME; these were even more pronounced for near than for distant activities. Adverse events were consistent with the known safety profile of intravitreal aflibercept., (Copyright © 2019 American Academy of Ophthalmology. Published by Elsevier Inc. All rights reserved.)

Published
2019
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19. Retinal photoreceptor apoptosis is associated with impaired serum ionized calcium homeostasis in diabetic retinopathy: An in-vivo analysis.

Author

Ankita, Saxena S, Nim DK, Stefanickova J, Ziak P, Stefanicka P, and Kruzliak P

Subjects
Female, Homeostasis, Humans, Male, Middle Aged, Tomography, Optical Coherence, Visual Acuity, Apoptosis, Calcium blood, Diabetic Retinopathy blood, Diabetic Retinopathy pathology, Photoreceptor Cells, Vertebrate pathology
Abstract

Purpose: The aim of this work was to study the association of serum ionized calcium with retinal photoreceptor apoptosis on spectral domain optical coherence tomography (SD-OCT) in diabetic retinopathy (DR)., Methods: Sixty consecutive cases with Type 2 diabetes mellitus were categorized into three groups: no diabetic retinopathy; non-proliferative DR; proliferative DR. The eye with more severe form of the disease was considered. Twenty healthy controls were also included. Best corrected visual acuity (BCVA) was measured on logMAR scale. Retinal photoreceptor apoptosis was defined as disruption of retinal photoreceptor ellipsoid zone (EZ). Ellipsoid zone disruption was assessed using SD-OCT. Serum levels of total and ionized calcium were measured using standard protocol., Results: EZ disruption was found to be positively associated with serum total calcium and ionized calcium. Also, EZ disruption was found to be positively associated with logMAR BCVA., Conclusion: Increased serum ionized calcium induces retinal photoreceptor apoptosis resulting in increased EZ disruption in DR., (Copyright © 2018 Elsevier Inc. All rights reserved.)

Published
2019
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20. A noninterventional study to monitor patients with diabetic macular oedema starting treatment with ranibizumab (POLARIS).

Author

Stefanickova J, Cunha-Vaz J, Ulbig M, Pearce I, Fernández-Vega Sanz A, Theodossiadis P, Kodjikian L, Izmailov A, Muston D, Vassilev Z, Lamotte B, Tückmantel C, Friedl S, Altemark A, Schwarz HJ, and Katz T

Subjects
Angiogenesis Inhibitors administration & dosage, Diabetic Retinopathy drug therapy, Diabetic Retinopathy physiopathology, Dose-Response Relationship, Drug, Drug Administration Schedule, Europe, Female, Fluorescein Angiography, Follow-Up Studies, Fundus Oculi, Humans, Intravitreal Injections, Macular Edema diagnosis, Macular Edema etiology, Male, Middle Aged, Retrospective Studies, Time Factors, Tomography, Optical Coherence, Vascular Endothelial Growth Factor A antagonists & inhibitors, Diabetic Retinopathy complications, Macula Lutea diagnostic imaging, Macular Edema drug therapy, Monitoring, Physiologic methods, Ranibizumab administration & dosage, Visual Acuity
Abstract

Purpose: Antivascular endothelial growth factor agents are increasingly used in diabetic macular oedema (DME); however, there are few studies exploring their use in DME in real-world settings., Methods: POLARIS was a noninterventional, multicentre study to monitor 12-month outcomes in patients starting ranibizumab treatment in routine practices. The primary outcome was mean change in visual acuity (VA) from baseline to month 12 (last observation carried forward approach). Other outcomes included mean change in central retinal thickness (CRT) and resource utilization. Visual acuity (VA) outcomes were also stratified by country, baseline visual acuity score (VAS), sex, age and injection frequency., Results: Outcomes were analysed from all treated patients (n = 804) and from first-year completers (patients who had a visual acuity assessment at 12 months; n = 568). The mean (SD) baseline VAS was 59.4 (15.9) letters, and the mean change in visual acuity was 4.4 letters (95% confidence interval: 3.3-5.4) at month 12 (study eye; first-year completers). The mean number of injections (study eye) was 4.9, and the mean number of all visits (any eye) was 10 (58% were injection visits) over 12 months (first-year completers). The mean (SD) baseline CRT was 410.6 (128.8) μm, and the mean change in CRT was -115.2 μm at month 12 (study eye; first-year completers). Visual acuity (VA) outcomes were generally comparable across most countries and subgroups and were greatest in patients with the lowest baseline VAS (≤60 letters)., Conclusion: POLARIS showed that real-world outcomes in DME patients starting treatment with ranibizumab were lower than those observed in clinical studies, in spite of extensive monitoring., (© 2018 The Authors. Acta Ophthalmologica published by John Wiley & Sons Ltd on behalf of Acta Ophthalmologica Scandinavica Foundation.)

Published
2018
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21. Prevalence of Age-Related Macular Degeneration in Slovakia and Associated Risk Factors: A Mobile Clinic-Based Cross-Sectional Epidemiological Survey.

Author

Krasnik V, Stefanickova J, Popov I, Valaskova J, Saxena S, and Kruzliak P

Subjects
Age Distribution, Age Factors, Aged, Aged, 80 and over, Cross-Sectional Studies, Female, Humans, Macular Degeneration diagnosis, Male, Middle Aged, Prevalence, Prospective Studies, Risk Factors, Slovakia epidemiology, Surveys and Questionnaires, Tomography, Optical Coherence, Macular Degeneration epidemiology, Mobile Health Units statistics & numerical data, Population Surveillance methods, Risk Assessment methods
Abstract

Purpose: Age-related macular degeneration (AMD) is one of the leading causes of blindness in the elderly population. Although there are prevalence studies for AMD in Europe, data are scarce for the Slovakian population., Methods: This was a prospective, multicenter, non-interventional, mobile clinic-based cross-sectional study that assessed age-specific prevalence of AMD in the Slovakian population and risk factors associated with AMD. The type of AMD was graded based on the international age-related maculopathy grading system; optical coherence tomography (OCT) was used for the differential diagnosis. Overall, 3,278 patients were screened; the fundus photographs, OCT scans, and self-reports were collected at the mobile clinic in a single visit., Results: The prevalence of AMD in the study population was 8.99% (wet AMD 1.01%; dry AMD 7.85%), whereas the extrapolated estimate in the entire Slovakian population was 3.3% (wet AMD 0.3%; dry AMD 3.0%). Age, smoking, and hypertension were risk factors associated with AMD; however, contrary to reports in the literature, no gender-specific association was observed., Conclusion: Based on the results of this study, mobile clinics may be an effective way to extend health care access to a larger population. Early diagnosis of AMD will assist in early treatment and effective disease management of the population at risk.

Published
2018
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22. The Impact of Hyperglycemia on VEGF Secretion in Retinal Endothelial Cells.

Author

Caprnda M, Kubatka P, Saxena S, Valaskova J, Stefanickova J, Kobyliak N, Zulli A, and Kruzliak P

Subjects
Animals, Cell Proliferation drug effects, Cell Proliferation physiology, Cell Survival, Cells, Cultured, Diabetic Retinopathy pathology, Endothelial Cells cytology, Enzyme-Linked Immunosorbent Assay, Female, Glucose metabolism, Haplorhini, Humans, Male, Reference Values, Retina cytology, Sensitivity and Specificity, Diabetic Retinopathy physiopathology, Glucose pharmacology, Hyperglycemia complications, Vascular Endothelial Growth Factor A analysis
Abstract

Background: Diabetic retinopathy is a serious sight-threatening complication which is manifested by excessive angiogenesis in diabetic patients., Aim: We hypothesize that cultured Rhesus monkey retinal endothelial cells (RhRECs) respond to high glucose with a change in cell proliferation and vascular endothelial growth factor (VEGF) secretion., Materials and Methods: In our study, 20 000 cells per well were treated without glucose or with 5.5 mM, 18.5 mM and 30 mM glucose for 24 hours. Viable cells were counted using trypan blue dye exclusion method. VEGF concentrations were measured in cell media by ELISA method., Results: The number of viable cells incubated with 5.5 mM glucose increased significantly by 53.7% after 24 hours. In comparison, the number of viable cells decreased by 2.8% at 18.5 mM of glucose and by 20.4% at 30 mM of glucose after 24 hours of incubation. In contrast to this effect of glucose on the number of viable cells, a significant increase in VEGF levels (pg/mL) in the cell media with a glucose concentration of 0 mM compared to 5.5 mM of glucose was found. VEGF secretion in cell medium with 18.5 and 30 mM of glucose increased non-significantly in comparison with euglycemic levels., Conclusion: Our results show that viability of retinal endothelial cells and VEGF release are highly responsive to changes in glucose concentration. Such glucose-induced changes in retinal endothelial cells may negatively impact the integrity of the microvasculature in the diabetic retina leading to angiogenesis and microaneursym.

Published
2017
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