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Background: While randomized controlled trials (RCTs) are based on strict inclusion/exclusion criteria, non-interventional studies (NISs) might provide additional information to guide management in patients more representative to the real-world setting. The aim of this study was to compare baseline characteristics of patients receiving intravitreal treatment in the NIS OCEAN with those from published RCTs.Methods: The ongoing OCEAN study enrolled patients treated with ranibizumab for neovascular age-related macular degeneration (nAMD), diabetic macular oedema (DME) or branch/central retinal vein occlusion (B/CRVO). Baseline patient characteristics were compared by indication within the OCEAN cohort. Furthermore, the characteristics were set in reference to those of published RCTs in the same indications. Confidence intervals (CIs) were calculated and assessed for statistically significant differences as indicated by non-overlapping CIs.Results: Patient characteristics in the NIS OCEAN were evaluated for 3,614 patients with nAMD, 1,211 with DME, 204 with BRVO and 121 with CRVO. Between these groups, significant differences in mean age, gender distributions, and mean baseline VA were seen, reflecting known differences between the indications. Compared to the patient characteristics of published RCTs (trials selected by literature search: nAMD: 13 RCTs, DME: 9, RVO: 5), the OCEAN patients' mean age was significantly higher in every indication. The gender distributions across the trials were comparable, with only few differences between OCEAN and the RCTs. Regarding the mean baseline VA, notable differences were found in nAMD and in DME, with VA significantly higher in some RCTs and lower in others.Conclusions: The described differences underline the complementarity of NISs and RCTs. OCEAN covers a broader spectrum and more variability of patients than do RCTs. As baseline values may have impact on the treatment response (ceiling effect), there is an ongoing need for research in all patient subgroups. Country-specific assessments of patient populations can better reflect the real-world situation. NISs can deliver insights that RCTs may not, as NISs can include non-typical patients, patients with comorbidities, a broader age spectrum and patients of various disease stages.Trial Registration: The NIS OCEAN was registered on www.clinicaltrials.gov (identifier: NCT02194803 ). [ABSTRACT FROM AUTHOR]

Background: Intravitreal injections are one of the most commonly performed ophthalmic procedures. It is estimated that over 1 million intravitreal injections are performed in Germany annually. The aim of this study was to quantify the waste and carbon footprint associated with single-use injection sets, and to establish a waste reduction strategy., Material and Methods: The clinical waste and associated carbon footprint from standard disposable injection sets used by tertiary referral centres in Germany (n = 6) and the United Kingdom (n = 2) were assessed. The safety of performing intravitreal injections with a minimalistic material-sparing approach was evaluated., Results: The average weight of an injection set (and hence the waste generated from each injection) was 165 g. On average, each injection set comprised 145 g (88%) of plastic, 2.1 g (1.3%) of metal, 4.3 g (2.6%) of paper, and 12.9 g (7.8%) of gauze/swabs. The production of such injection sets was extrapolated to a CO 2 equivalent of 752.6 tonnes (t), and the incineration of the resulting waste to a CO 2 equivalent of 301.7 t. For 1 million injections, this equates to 145.2 t of plastic, 2.1 t of metal, 4.3 t of paper, and 12.9 t of gauze/swabs. A material-sparing approach can reduce injection set-associated waste by 99% without necessarily compromising patient safety., Conclusion: A resource-saving approach to intravitreal injections can minimise the generation of clinical waste and its associated carbon footprint, thereby supporting sustainability., Competing Interests: Die Autorinnen/Autoren geben an, dass kein Interessenkonflikt besteht./The authors declare that they have no conflict of interest., (Thieme. All rights reserved.)

Background: The Masterplan Medicine 2020 adopted in 2017 entails many changes to the medical studies curriculum. The new structure affects the content of the coursework and its main focus. A major goal of this masterplan is to prepare young physicians by teaching the skills that are essential for the future profession. The National Competence-Based Learning Objectives Catalog for Medicine (NKLM) provides the basis for the teaching content., Methods: The Working Group Teaching of the German Society of Ophthalmology (Arbeitsgemeinschaft Lehre der DOG) actively supports this transformation. In cross-site collaboration, teaching materials for various teaching formats have been compiled by relying on the NKLM (e.g., recordings of operations, slides for small group instruction, image galleries, case studies). An online library named the DOG-EyeTeacher was then created., Results: The aim of the DOG-EyeTeacher is to relieve the training clinics and to establish basic standards in teaching materials, thereby enabling the necessary focus on medical education. The provision of these teaching materials should deepen the interest in ophthalmology among future doctors., Conclusion: The DOG-EyeTeacher is our response to the challenges associated with the planned restructuring of the medical curriculum. Since October 2023, any DOG member involved in teaching can create an account free of charge to use our materials., (© 2024. The Author(s).)

Background: AURIGA is the largest prospective real-world study to evaluate intravitreal aflibercept 2 mg (IVT-AFL) treatment of macular edema (ME) secondary to retinal vein occlusion (RVO) and diabetic macular edema. Here we present the 24-month data from the German cohort of treatment-naïve patients with ME due to RVO., Methods: Treatment-naïve patients with ME secondary to RVO were treated with IVT-AFL 2 mg in the routine clinical practice. The primary endpoint was mean change in visual acuity (VA, early treatment diabetic retinopathy, ETDRS, letters) at month 12 compared to baseline. Analyses were descriptive., Results: Analysis included 130 patients with RVO (n = 61, 46.9% with central RVO, n = 69, 53.1% with branch RVO). The mean (± SD) time the RVO patients remained in the study was 18.4 ± 7.4 months. The mean VA gain (95% confidence interval) in the overall cohort was +10.9 (7.5-14.2) letters at month 12 and +9.7 (6.1-13.3) at month 24 (baseline VA 56.5 ± 18.9 letters). At 24 months, 67% of RVO patients gained ≥5 letters and 40% gained ≥15 letters. The mean number of injections was 4.4 ± 1.3 up to month 6, 6.2 ± 2.7 up to month 12 and 8.2 ± 4.5 up to month 24. The mean central retinal thickness (CRT) reduction was -206µm (-252 to -160µm) at 12 months and -219µm (-263 to -175µm) at 24 months (baseline CRT 507 ± 177 µm). The safety profile was consistent with that of previous studies., Discussion: In the German AURIGA cohort of treatment-naïve patients with ME secondary to RVO, IVT-AFL 2 mg treatment in clinical practice resulted in rapid and clinically relevant VA gains and a reduction in CRT. These results were largely maintained over 24 months despite the low injection frequency from month 6., (© 2024. The Author(s).)

Purpose: In recent years artificial intelligence (AI), as a new segment of computer science, has also become increasingly more important in medicine. The aim of this project was to investigate whether the current version of ChatGPT (ChatGPT 4.0) is able to answer open questions that could be asked in the context of a German board examination in ophthalmology., Methods: After excluding image-based questions, 10 questions from 15 different chapters/topics were selected from the textbook 1000 questions in ophthalmology (1000 Fragen Augenheilkunde 2nd edition, 2014). ChatGPT was instructed by means of a so-called prompt to assume the role of a board certified ophthalmologist and to concentrate on the essentials when answering. A human expert with considerable expertise in the respective topic, evaluated the answers regarding their correctness, relevance and internal coherence. Additionally, the overall performance was rated by school grades and assessed whether the answers would have been sufficient to pass the ophthalmology board examination., Results: The ChatGPT would have passed the board examination in 12 out of 15 topics. The overall performance, however, was limited with only 53.3% completely correct answers. While the correctness of the results in the different topics was highly variable (uveitis and lens/cataract 100%; optics and refraction 20%), the answers always had a high thematic fit (70%) and internal coherence (71%)., Conclusion: The fact that ChatGPT 4.0 would have passed the specialist examination in 12 out of 15 topics is remarkable considering the fact that this AI was not specifically trained for medical questions; however, there is a considerable performance variability between the topics, with some serious shortcomings that currently rule out its safe use in clinical practice., (© 2024. The Author(s), under exclusive licence to Springer Medizin Verlag GmbH, ein Teil von Springer Nature.)

Two COVID-19 outbreaks occurred in residential buildings with overcrowded housing conditions in the city of Göttingen in Germany during May and June 2020, when COVID-19 infection incidences were low across the rest of the country, with a national incidence of 2.6/100,000 population. The outbreaks increased the local incidence in the city of Göttingen to 123.5/100,000 in June 2020. Many of the affected residents were living in precarious conditions and experienced language barriers. The outbreaks were characterized by high case numbers and attack rates among the residents, many asymptomatic cases, a comparatively young population, and substantial outbreak control measures implemented by local authorities. We analyzed national and local surveillance data, calculated age-, and gender-specific attack rates and performed whole genome sequencing analysis to describe the outbreak and characteristics of the infected population. The authorities' infection control measures included voluntary and compulsory testing of all residents and mass quarantine. Public health measures, such as the general closure of schools and a public space as well as the prohibition of team sports at local level, were also implemented in the district to limit the outbreaks locally. The outbreaks were under control by the end of June 2020. We describe the measures to contain the outbreaks, the challenges experienced and lessons learned. We discuss how public health measures can be planned and implemented through consideration of the needs and vulnerabilities of affected populations. In order to avoid coercive measures, barrier-free communication, with language translation when needed, and consideration of socio-economic circumstances of affected populations are crucial for controlling infectious disease transmission in an outbreak effectively and in a timely way., Competing Interests: The authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest., (Copyright © 2021 Zimmermann, Sarma, Thieme-Thörel, Alpers, Artelt, Azouagh, Bremer, Broistedt, Eckmanns, Feltgen, Huska, Kröger, Puls, Scheithauer, Mayr and Rexroth.)

Purpose: To evaluate the influences and risk factors for severe bleeding complications during vitreoretinal surgery and to investigate the role of antiplatelet and anticoagulant agents., Design: Prospective trial., Participants: Patients undergoing vitreoretinal surgery., Methods: The procedures included were pars plana vitrectomy and scleral buckling. We developed a uniform classification to grade the bleeding severity. Bleeding was graded on an ordinal scale ranging from 0 to 5. Immediately after surgery and 1 day later, the incidence and the severity of bleeding events was documented on a standardized form. A grade of 3 or more was defined as severe bleeding. Furthermore, the influence of known systemic disorders before surgery, the type of anesthesia, type of surgical procedure, intraoperative blood pressure, and the use or change of antiplatelet or anticoagulant agents on intraoperative bleeding was analyzed., Main Outcome Measures: Incidence and risk factors for severe intraoperative bleeding events., Results: Data from 374 eyes undergoing vitreoretinal procedures were included in our study (mean age, 67.6 ± 12.9 years). A severe intraoperative bleeding event was observed in 15 eyes (4%). We found that concomitant diseases such as diabetes mellitus and carotid artery stenosis, the presence of diabetic retinopathy, younger age, and scleral buckling combined with a transscleral puncture were associated significantly with severe bleeding events. By contrast, use of antiplatelet or anticoagulant agents, or both, had no significant influence on severe intraoperative bleeding events., Conclusions: Although external manipulations during buckling surgery (e.g., drainage of subretinal fluid) and concomitant diseases such as diabetes mellitus and carotid artery stenosis influences the risk of severe intraoperative bleeding events, we did not detect an increased risk related to coexisting antiplatelet or anticoagulant medication use, or both., (Copyright © 2021 American Academy of Ophthalmology. Published by Elsevier Inc. All rights reserved.)

Background: Survey by the commission for cross-sectoral ophthalmology, as a joint commission of the German Ophthalmological Society (DOG) and the Professional Association of German Ophthalmologists (BVA) on the effects of the SARS-CoV‑2 pandemic on ophthalmological patient care in Germany., Methods: Online-based survey., Results: A total of 1190 questionnaires were (partly) answered. With respect to outpatient care and consultations from 15 March to 15 April 2020, a total of 69 (5.8%) participants indicated unlimited, 756 (63.5%) reduced and 330 (27.7%) emergency care only, independent of the type of institution. Outpatient surgery was restricted to emergency surgery in 68% of clinics, 42.0% of inpatient wards, 45.0% of surgical medical care centers and group practices and 33.0% of private practices. Inpatient procedures were limited to emergency care in 75.0% of inpatient wards and in 71.0% of clinics. With the exception of endophthalmitis (+8.2%), the number of urgent indications and emergencies declined: retinal detachment (-34.8%), perforating eyeball injuries (-7.3%), acute glaucoma (-17.8%), central retinal artery occlusion and anterior ischemic optic neuropathy (-31.0%), others (-30.9%), penetrating keratoplasty and amniotic membrane transplantation (-59.1%). Institutional or professional policy requirements (76.0%) and appointment cancellation by patients (84.0%) were the most common reasons for limitations in ophthalmic patient care., Conclusion: The initial phase of the pandemic was characterized by a massive reduction in non-urgent conservative and surgical treatment that affected all areas of ophthalmology. Due to intensive care capacities required for COVID-19 patients, inpatient treatment was largely restricted to emergencies. Treatment of ophthalmological patients, including ocular emergencies and urgent treatment, was maintained across all sectors with a (considerable) decrease in the number of cases even in these groups., (© 2021. Springer Medizin Verlag GmbH, ein Teil von Springer Nature.)

Background: Currently two intravitreally applied corticosteroids (dexamethasone and fluocinolone) are licensed in Germany for treatment of diabetic macular oedema (DME). The use of DEX implant for DME in daily clinical practice has not been defined in detail. Following a Delphi panel survey, a group of retina experts set out to come up with a consensus for use of the DEX implant in DME., Material and Methods: International and national treatment recommendations were identified from the literature. A steering group generated a catalogue of 72 statements on the aetiology and pathogenesis of DME, therapy with DEX implant, use of DEX implant in patients previously treated with VEGF-inhibitors, use of DEX implant in combination therapy, safety of DME therapies as well as patients' burden of treatment. Twenty-two ophthalmologists from private practice and 6 hospital ophthalmologists participated in the Delphi panel via Survey Monkey. Consensus was reached if at least 75% of participants agreed or disagreed with a statement. Statements for which consensus was not reached were discussed once more during the expert consensus meeting and a vote was taken. Based on these results a treatment algorithm for foveal DME was proposed., Results: If a patient does not show sufficient response after 3 - 6 months of anti-VEGF treatment (visual acuity gain of < 5 ETDRS letters or reduction of central retinal thickness ≤ 20%), a switch to DEX implant should take place. DEX implant is also suitable in eyes with longer presentation of DME, showing e.g. massive lipid exudates. DEX implant is suitable as first-line therapy especially in pseudophakic patients, patients unwilling or able to comply with tight anti-VEGF injection intervals or patients with known vascular diseases. With fixed control visits every 4 - 8 weeks, use of DEX implant is flexible and individual. Decision parameters for repeated use should be visual acuity, retinal thickness and intraocular pressure. Treatment of both eyes on the same day should not take place., Conclusion: The algorithm presented reflects survey as well as expert discussion results and may differ from recommendations issued by the German professional society. The consensus recommendations for the treatment of DME generated during the survey and meeting of retina experts are intended to guide use of DEX implant in daily practice., Competing Interests: B: Teilnahme an Beratungsgremien von Firmen, F: Forschungsunterstützung erhalten von Firmen, V: Vortraghonorare erhalten von Firmen. Augustin AJ: B: Alimera, Allergan; F: Alimera, Allergan, Novartis, Bayer; V: Alimera, Allergan. Feltgen NJ: B: Roche Pharma, Novartis Pharma, Alimera Science; F: Bayer Healthcare, Roche Pharma, Novartis Pharma, Allergan; V: Heidelberg Ing, Allergan, Novartis Pharma, Bayer Healthcare. Haritoglu C: B: Allergan, Novartis; V: Allergan, Bayer, Novartis, Alimera. Hoerauf H: B: Bayer, Alimera, Thrombogenics, Alcon/Novartis, Allergan; F: Bayer, Heidelberg Engineering, Carl Zeiss Meditec, Roche/Genentech, Ophthotech, Lutronic, Regeneron, Boehringer Ingelheim, Bioeq/Formycon, Alcon/Novartis, Allergan; V: Bayer, Heidelberg Engineering, Alimera, Alcon/Novartis, TheaPharma, Thrombogenics und Allergan. Maier M: F: Novartis, Bayer, Roche (klinische Studien); V: Allergan, Bayer, Novartis, Heidelberg Engineering, Zeiss. Mardin C: B: Allergan, Heidelberg Engineering; F: Heidelberg Engineering; V: Heidelberg Engineering, Novartis, Bayer, Allergan. Schargus M: B: Allergan; V: Allergan, Novartis., (Thieme. All rights reserved.)

Background: Survey by the commission for cross-sectoral ophthalmology, as a joint commission of the German Ophthalmological Society (DOG) and the Professional Association of German Ophthalmologists (BVA) on the effects of the SARS-CoV‑2 pandemic on ophthalmological patient care in Germany., Methods: Online-based survey., Results: A total of 1190 questionnaires were (partly) answered. With respect to outpatient care and consultations from 15 March to 15 April 2020, a total of 69 (5.8%) participants indicated unlimited, 756 (63.5%) reduced and 330 (27.7%) emergency care only, independent of the type of institution. Outpatient surgery was restricted to emergency surgery in 68% of clinics, 42.0% of inpatient wards, 45.0% of surgical medical care centers and group practices and 33.0% of private practices. Inpatient procedures were limited to emergency care in 75.0% of inpatient wards and in 71.0% of clinics. With the exception of endophthalmitis (+8.2%), the number of urgent indications and emergencies declined: retinal detachment (-34.8%), perforating eyeball injuries (-7.3%), acute glaucoma (-17.8%), central retinal artery occlusion and anterior ischemic optic neuropathy (-31.0%), others (-30.9%), penetrating keratoplasty and amniotic membrane transplantation (-59.1%). Institutional or professional policy requirements (76.0%) and appointment cancellation by patients (84.0%) were the most common reasons for limitations in ophthalmic patient care., Conclusion: The initial phase of the pandemic was characterized by a massive reduction in non-urgent conservative and surgical treatment that affected all areas of ophthalmology. Due to intensive care capacities required for COVID-19 patients, inpatient treatment was largely restricted to emergencies. Treatment of ophthalmological patients, including ocular emergencies and urgent treatment, was maintained across all sectors with a (considerable) decrease in the number of cases even in these groups.

Background: Future developments of teaching in human medicine and ophthalmology emphasize the need of a learning target index to standardize and modernize education at German universities. The first measure is the elaboration of a learning target index of the German Ophthalmological Society (DOG)., Method: The masterplan medicine 2020 has been passed by German authorities in 2017 to restructure studies in human medicine at German universities according to a concept of skill-related learning objectives rather than based on factual knowledge. The executive committee of the DOG, together with all subsections, accepted the first version of the learning target index elaborated by the authors on 30 May 2016., Results: The learning target index for ophthalmology encompasses 25 chapters, whereby chapter 1 is dedicated to the investigation methods and treatment. Chapters 2-23 deal with the diseases and are subdivided according to definition and leading symptoms, pathogenesis as well as diagnostics and treatment. To correspond to the need to focus on core items individual chapters are introduced for glaucoma, diabetic retinopathy, age-related macular degeneration and retinal detachment. Differential diagnoses and main symptoms are dealt with in chapter 24, the epidemiology and causes of blindness in chapter 25. The depths of competence are presented for the groups of all students and the practical competence (depth of competence 3) is dealt with separately for semester students and students in the practical year., Conclusion: This learning target index for ophthalmology is the first approved by the DOG and represents a first step to further improve medical education in ophthalmology at German universities. The new teaching standards for studies in human medicine related to the masterplan medicine 2020 reflect the need of a consented approach to improve educational standards in ophthalmology so that all topics in ophthalmology remains sufficiently represented despite the specification to focus on high priority core items.

Background: The deployment of lecturers and different teaching strategies at German university eye clinics were assessed via a questionnaire., Methods: In an online questionnaire the lecturers at German university eye clinics were asked to answer a total of 28 questions. The questions had been agreed upon by the German Ophthalmological Society (DOG) teaching group., Results: A total of 30 lecturers from the 36 German university clinics answered the questionnaire (83%). At most of the locations, a half-year course during one semester is held with a median of 180 students taking the course. The median number of teaching hours per semester and clinic was 112 h. Whereas financial support for lecturing is available from the faculty in many locations, only six clinics also allotted lecturers time to organize the teaching. The practical examinations already established in other subjects (objective structured clinical examination, OSCE) are carried out at roughly every third clinic., Conclusion: This survey revealed a high level of commitment on the part of lecturers at German university eye clinics. The diversity of local conditions poses a challenge to ensuring comparable teaching standards in Germany. Support from the respective clinic administration/faculty could be improved at many locations.

The perioperative treatment of retinal surgery with anti-inflammatory drugs is an everyday procedure for ophthalmologists in Germany. Nevertheless, little data are available to investigate the efficacy of vitreoretinal surgery. Treatment is usually analogous to procedures on the anterior segment of the eye, for which much more robust data are available. In this article, the relevant clinical questions will be answered and, when possible, documented with study data., Competing Interests: Die Autoren geben an, dass kein Interessenkonflikt besteht., (Georg Thieme Verlag KG Stuttgart · New York.)

Introduction: As our population ages and comorbidities rise, ophthalmic surgeons are increasingly faced with patients on anticoagulant therapy or with clotting disorders. The ophthalmic surgeon has to weigh the perioperative risk of haemorrhage when anticoagulation continues against the risk of thromboembolism caused by discontinuation or changing the patient's medication (bridging, switching, cessation). There are currently no guidelines or recommendations., Methods: A survey was sent to the DOG (German Ophthalmologic Society) divisions and associated surgical organizations to determine the status quo. A questionnaire was sent out and filled out by the different groups of specialists., Results: All four divisions of the DOG and four associated organizations returned completed questionnaires. Surgical interventions were listed that are carried out during anticoagulant therapy without exceptions, as well as interventions that were classified to require medical adjustment. Although the assessments varied, general consensus was achieved regarding interventions not requiring adjustments due to anticoagulants (i. e., intravitreal injection, cataract surgery, laser and corneal operations, simple muscle surgery), and those interventions requiring adjustments in medications (glaucoma operations, complex retina surgery, eye socket surgery, complex surgery of the lid)., Conclusion: Main result of this survey was the specification of serious bleeding complications which are permanent vision loss and re-operation. They could serve as endpoint parameters for essential future investigations. Nevertheless, this survey makes clear that the decision about an adjustment of anticoagulant medication in ophthalmic surgery is currently made individually and not based on established standards.

Background: University teaching in ophthalmology has tended to focus on imparting knowledge rather than practical skills. The new skills laboratory at the University Medical Center in Göttingen enables practical skills to be taught. The focus is on basic skills that could help all physicians. The learning goals set are techniques considered basic in ophthalmology that can be mastered without requiring any physician to operate major equipment., Methods: The design and results from four semesters of an ophthalmological objective structured clinical examination (OSCE) following students engaged in peer-teaching, as well as feedback from a student questionnaire are described., Results: Practical skills can successfully be taught and mastered within 1 week and 68-100 % of all students achieved the maximum scores in the individual tests. The OSCE and peer- eaching were well received by the students., Conclusions: Practical skills and peer teaching fulfill student educational goals in ophthalmology and are well accepted by undergraduates.

The results of conservative treatment for central retinal artery occlusion (CRAO) vary considerably and although local intraarterial fibrinolysis (LIF) is a promising treatment, outcomes have not been compared in randomized trials. The prospective randomized multicenter study by the European Assessment Group for Lysis in the Eye (EAGLE) is the first clinical trial to compare treatment outcomes of conservative standard treatment (CST) and LIF for acute non-arteritic CRAO. Patients (age 18-75 years) with CRAO present for less than 20 h and best-corrected visual acuity (BCVA) <0.5 logMAR were randomized to either CST or LIF group. Primary endpoint was BCVA after 1 month and secondary endpoint was safety. Mean BCVA (logMAR) improved significantly in both groups and did not differ between the groups. Because of similar efficacy and the higher rate of adverse events in the LIF group the study was halted after the first interim analysis. Due to the similar outcomes of the two therapies and the higher rate of adverse reactions associated with LIF superselective lysis cannot be recommended for the management of acute CRAO.

Originating from therapeutic concepts in oncology, angioinhibitory strategies have changed the way ophthalmological patients are treated for a variety of diseases like age-related macular degeneration, diabetic retinopathy or retinal vein occlusion. It is likely that these therapeutic options will not be limited to retinal disease, but will also prove useful for corneal disorders associated with lymph- or angiogenesis. This review is intended to provide a concise overview of the current options investigated in clinical trials.