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Disorders of blood coagulation can lead to manifest spontaneous bleeding and an increased risk of bleeding during surgical procedures and interventions. Pathophysiologically, a distinction can be made between defects in primary haemostasis, which lead to impaired platelet adhesion and platelet aggregation, and disorders of secondary (plasmatic) haemostasis, which are characterised by impaired fibrin formation or fibrin stabilisation. Aetiologically, a distinction can be made between rare genetically-determined hereditary defects and common acquired coagulation disorders, which may be based on different pathomechanisms. This overview is intended to provide ophthalmic surgeons with a basis for the perioperative management of patients with genetically determined coagulation disorders undergoing ophthalmic surgery. As there are no specific recommendations in this regard, the recommendations are based on the procedure for other surgical interventions, taking into account the specific bleeding risk associated with ophthalmic surgery.
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Transtornos da Coagulação Sanguínea , Procedimentos Cirúrgicos Oftalmológicos , Assistência Perioperatória , Humanos , Procedimentos Cirúrgicos Oftalmológicos/métodos , Procedimentos Cirúrgicos Oftalmológicos/efeitos adversos , Transtornos da Coagulação Sanguínea/diagnóstico , Transtornos da Coagulação Sanguínea/etiologia , Assistência Perioperatória/métodos , Perda Sanguínea Cirúrgica/prevenção & controleRESUMO
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 CO2 equivalent of 752.6 tonnes (t), and the incineration of the resulting waste to a CO2 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.
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PURPOSE: To investigate the lower visual acuity threshold for recommending intravitreal injection therapy (IVI). The lower limit of 1.3 logMAR best-corrected visual acuity (BCVA) was adopted in 2006 and has been maintained since then. METHODS: In this retrospective study, data from patients with a logMAR BCVA ≤ 1.3 and 24 months follow-up were analysed. We included patients with neovascular age-related macular degeneration (nAMD), diabetic macular oedema (DME), or retinal vein occlusion (RVO). RESULTS: The data from 164 patients (nAMD: 107; DME: 15; RVO: 42) were analysed. We observed a significant improvement at all time intervals (0 to 6, 6 to 12, 12 to 18, and 18 to 24 months after initiating IVI) compared to baseline. Across all indications, median BCVA improved from 1.4 to 1.0 within the first 6 months and remained stable within 24 months. Patients received a median of 5 and 10 injections within 6 and 24 months, respectively. Median foveal retinal thickness was 594.5 µm at baseline and dropped to 244.5 µm, 235.5 µm, 183 µm, and 180 µm during the four consecutive time intervals. CONCLUSION: Patients with nAMD, DME, and RVO with poor baseline BCVA may also benefit from intravitreal therapy with VEGF-inhibitors. In the present study, we observed functional and morphological improvement over 2 years irrespective of the underlying macular disease. Those patients should not be excluded from therapy.
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Inibidores da Angiogênese , Oclusão da Veia Retiniana , Humanos , Estudos Retrospectivos , Injeções Intravítreas , Inibidores da Angiogênese/uso terapêutico , Retina , Oclusão da Veia Retiniana/tratamento farmacológico , Acuidade VisualRESUMO
Retinal vascular occlusion not only threatens vision loss but is also associated with other systemic risk factors and vascular diseases. Interdisciplinary cooperation is of great importance in these patients. The risk factors hardly differ between arterial and venous retinal occlusions, which is due to the special anatomy of retinal vessels. Major underlying conditions associated with retinal vascular occlusion include arterial hypertension, diabetes mellitus, dyslipidemia, cardiac disease, particularly atrial fibrillation, or vasculitis of large- and middle-sized arteries. Every new diagnosed retinal vascular occlusion should therefore be taken as an occasion to search for risk factors and possibly adjust an already existing therapy in order to prevent further vascular events.
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Oclusão da Artéria Retiniana , Doenças Retinianas , Oclusão da Veia Retiniana , Vasculite , Humanos , Oclusão da Veia Retiniana/diagnóstico , Oclusão da Veia Retiniana/terapia , Oclusão da Veia Retiniana/complicações , Retina , Fatores de Risco , Oclusão da Artéria Retiniana/diagnóstico , Oclusão da Artéria Retiniana/terapiaRESUMO
Laser flare photometry provides a non-invasive and objective measurement of the Tyndall effect in the anterior chamber. The laser flare value (measured in photon number per millisecond [pc/ms]) thus quantifies the extent of disruption to the blood-aqueous barrier and can be used in clinical applications to monitor uveitis therapy or to measure the postoperative degree of inflammation. Standardised performance must be observed during measurement. Publications of the last 35 years on laser flare photometry deal not only with the measurement procedure but also with its use in clinical practice for different ophthalmological pathologies. Likewise, various influencing factors have already been investigated and described that must be considered when measuring and evaluating laser flare values. The focus of this article is the relevance of laser flare photometry in retinal pathologies. In recently published studies, the level of objective tyndallometry in primary rhegmatogenous retinal detachment is shown to depend on lens status, symptom duration, and extent of retinal detachment. The greater is the area of the retina affected, the greater the disruption of the blood-aqueous barrier appears to be. Elevated laser flare values have also been considered as a predictor for the development of proliferative vitreoretinopathy (PVR). However, based on current knowledge, this assumption must be put into perspective. According to current data, objective tyndallometry can be used to monitor the progression of intraocular inflammation and to quantify the blood-aqueous barrier, and the values correlate with the extent and anatomical features, as well as the symptom duration in retinal detachment. Many influencing factors have already been identified. But further evaluation is desirable and needed. It is still unclear whether laser flare values can be used in the future as a predictor for sequelae such as PVR development.
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Descolamento Retiniano , Uveíte , Vitreorretinopatia Proliferativa , Humanos , Descolamento Retiniano/cirurgia , Humor Aquoso , Uveíte/diagnóstico , Uveíte/complicações , Inflamação , Retina , Fotometria/métodos , LasersRESUMO
PURPOSE: The purpose of this study was to investigate preoperative blood-ocular barrier disruption via laser flare photometry (LFP) in patients diagnosed with rhegmatogenous retinal detachment (RRD), and to analyse possible associations with symptom duration and anatomical parameters. METHODS: We retrospectively analysed consecutive patients presenting with RRD at a single centre between January 2016 and March 2020. LFP was performed in both eyes after pupillary dilatation prior to RRD surgery. Symptom duration, extent of retinal detachment, and lens status were assessed. For statistical analysis, we carried out the unequal variances t test and Welch's analysis of variance (ANOVA). RESULTS: We included 373 eyes of 373 patients (mean age 63.96 years ± 10.29; female:male ratio 1:1.8). LFP values quantified in photon count per millisecond (pc/ms) increased with longer symptom duration when comparing patients with a symptom duration of 0-3 days (n = 158; 9.25 ± 6.21 pc/ms) and ≥ 4 days (n = 215; 11.97 ± 11.58 pc/ms; p = 0.004). LFP values also rose with the number of retinal quadrants affected by RRD (1 quadrant, 6.82 ± 4.08 pc/ms; 2 quadrants, 10.08 ± 7.28 pc/ms; 3 quadrants, 12.79 ± 7.9 pc/ms; 4 quadrants, 31.57 ± 21.27 pc/ms; p < 0.001), macula off status (macula on, 8.89 ± 6.75 pc/ms; macula off, 12.65 ± 11.66 pc/ms; p < 0.001), and pseudophakic lens status (pseudophakia, 12.86 ± 9.52 pc/ms; phakia: 9.31 ± 9.67 pc/ms; p < 0.001). CONCLUSION: In RRD patients, blood-ocular barrier disruption quantified by LFP is associated with the duration of symptoms and the disease's anatomical extent. These results warrant further investigation of the potential clinical use of LFP in RRD.
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Descolamento Retiniano , Humanos , Masculino , Feminino , Pessoa de Meia-Idade , Descolamento Retiniano/diagnóstico , Descolamento Retiniano/cirurgia , Seguimentos , Estudos Retrospectivos , Acuidade Visual , Fotometria , Vitrectomia/métodosRESUMO
In the field of ophthalmology, central retinal artery occlusion is still one of the unsolved pathologies, as there is no widely accepted evidence-based therapeutic concept. Meta-analysis suggests that intravenous fibrinolysis might help to improve the outcome if performed within the first 4.5 hours after symptom onset. However, this short window of opportunity is often missed due to delays during diagnostic testing (e.g. time elapsed before performance of an ophthalmological examination) or patient-processing (referring the patient to a specialized medical facility). This article presents a diagnostic tool in the form of a simple questionnaire, comprising a medical history and examinations, which could help to minimize the time required to initiate the appropriate treatment.
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Oclusão da Artéria Retiniana , Fundo de Olho , Humanos , Oclusão da Artéria Retiniana/diagnóstico , Oclusão da Artéria Retiniana/terapiaRESUMO
BACKGROUND: The progression of the COVID-19 pandemic has caused significant changes in the environment for outpatient and inpatient care in ophthalmology, with limitations on access to medical care but also new observations and challenges. We now describe major developments in recent months and provide an outlook on the expected consequences. METHODS: PubMed literature search, clinical survey. RESULTS: To date, the course of the COVID-19 pandemic has been characterised by several new but overall rare ocular manifestations, the ophthalmological shared management of COVID-19 patients on intensive care units, and a significant decrease in case numbers, associated with an increase in case severity and relative proportion of emergencies, as a result of delayed presentation of patients and reduced treatment adherence. With the introduction of hygiene measures and infection control procedures, ophthalmic patient care was maintained - including emergencies and urgent treatments. Due to the extensive postponement of elective surgeries, scarce therapeutic and health care professional resources, and the prioritisation of critically ill patients from other specialties, there is a reasonable likelihood that urgent treatments will be delayed as infection rates rise. CONCLUSION: Outpatient and inpatient care in ophthalmology during the COVID-19 pandemic is primarily accompanied by additional organisational or medical challenges and a decline in case volume. Although to date emergency and urgent ophthalmic treatments have been maintained, long-term persistence of pandemic conditions will require additional strategies to provide continuation of ophthalmic care at the required level.
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COVID-19 , Pandemias , Humanos , Higiene , Pacientes Internados , Pacientes Ambulatoriais , SARS-CoV-2 , TriagemRESUMO
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 3â-â6 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 4â-â8 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.
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Diabetes Mellitus , Retinopatia Diabética , Edema Macular , Inibidores da Angiogênese/uso terapêutico , Tomada de Decisão Clínica , Consenso , Dexametasona/uso terapêutico , Retinopatia Diabética/diagnóstico , Retinopatia Diabética/tratamento farmacológico , Implantes de Medicamento , Alemanha , Glucocorticoides/uso terapêutico , Humanos , Injeções Intravítreas , Edema Macular/tratamento farmacológico , Edema Macular/etiologia , Fator A de Crescimento do Endotélio VascularRESUMO
PURPOSE: To quantify short-term microvascular changes after pars plana vitrectomy (PPV) with internal limiting membrane (ILM) peeling in patients with idiopathic macular hole (IMH) using optical coherence tomography angiography (OCTA). DESIGN: Cohort Study. PARTICIPANTS: This study included patients with IMH. Affected eyes were compared with fellow eyes. METHODS: 6 × 6 mm OCTA (Zeiss Angioplex, Zeiss Meditec, Dublin, CA, USA) images of the study eye and fellow eye were acquired one day before surgery, 4 weeks and 12 weeks after surgery. Microvascular alterations in the superficial and deep capillary plexus were assessed by measuring vessel density and the shortest distance to the surrounding vessels of all intercapillary pixels. Only vessels enclosed by an ETDRS Grid centered on the fovea were analyzed. MAIN OUTCOME MEASURES: Change of vessel density and vessel distance to baseline. RESULTS: OCTA images of the 15 study and 15 fellow eyes of 15 included patients (mean ± SD of age: 67.89 ± 5.2 years) were analyzed and revealed a significant increase in vessel density and decrease in vessel distance of the deep capillary plexus in study eyes 4 weeks after surgery compared to baseline. Our superficial capillary plexus findings were the inverse, namely a significant decrease in vessel density and increase in vessel distance. Postoperative microvascular changes proved to be closely associated with the extent of retinal thickness reduction in the perifoveal deep capillary plexus. CONCLUSIONS: IMH closure after PPV and ILM peeling caused a significantly improved microvasculature in the deep capillary plexus, which may represent reorganized perifoveal microvasculature due to the regression of cystoid spaces.
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Angiofluoresceinografia/métodos , Fóvea Central/irrigação sanguínea , Microvasos/patologia , Perfurações Retinianas/diagnóstico , Vasos Retinianos/patologia , Tomografia de Coerência Óptica/métodos , Vitrectomia/métodos , Idoso , Feminino , Fundo de Olho , Humanos , Masculino , Período Pós-Operatório , Estudos Prospectivos , Perfurações Retinianas/cirurgia , Acuidade VisualRESUMO
PURPOSE: The goal of this study was to analyze the incidence of perioperative bleeding complications in rhegmatogenous retinal detachment. The handling of perioperative anticoagulation during vitreoretinal surgery remains controversial, since the risk of bleeding complications by its continuation has to be balanced against the risk of progression of retinal detachment and the risk of thromboembolic events when anticoagulation is interrupted. Nevertheless, only few studies have investigated the risk of perioperative bleeding complications in an emergency such as retinal detachment surgery. METHODS: We therefore examined the rate of all perioperative hemorrhages and separately the rate of only severe bleedings during vitrectomy, scleral buckling with or without drainage of subretinal fluid (SRD), or combined procedures due to retinal detachment in patients undergoing different types of perioperative anticoagulation including acetylsalicylic acetate (ASA), clopidogrel, heparin, low molecular weight heparin, and phenprocoumon. RESULTS: This retrospective single-center study included 893 patients with primary rhegmatogenous retinal detachment, n = 192 on anticoagulation and n = 701 serving as control without anticoagulation. Our analysis revealed no significantly increased rate of perioperative hemorrhages under anticoagulation with ASA 100 mg (all, 11.4%; severe, 5.0%) or phenprocoumon (all, 11.6%; severe, 2.3%) compared with controls (all, 13.0%; severe, 5.4%). However, frequencies of bleeding complications varied markedly regarding the type of surgical procedure: Scleral buckling plus SRD showed the highest rates of hemorrhages (all, 18.9%; severe, 9.1%) with significant difference (P < 0.001) compared with scleral buckling without SRD (all, 3.8%; severe, 0.6%) and vitrectomy (all, 9.2%; severe, 1.5%), respectively. Furthermore, subretinal bleeding was the most common type of perioperative hemorrhage. CONCLUSIONS: The data suggest not to stop ASA therapy prior to vitreoretinal surgery. Furthermore, we found no evidence of an increased risk for perioperative bleedings in patients under anticoagulation with vitamin-k antagonists with an INR within the sub-therapeutic range. SRD during scleral buckling procedure should be avoided as possible and regardless of any type of anticoagulation.
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Complicações Intraoperatórias/epidemiologia , Complicações Pós-Operatórias/epidemiologia , Descolamento Retiniano/cirurgia , Hemorragia Retiniana/epidemiologia , Recurvamento da Esclera , Vitrectomia , Adolescente , Adulto , Idoso , Idoso de 80 Anos ou mais , Anticoagulantes/uso terapêutico , Aspirina/uso terapêutico , Criança , Pré-Escolar , Clopidogrel/uso terapêutico , Drenagem , Feminino , Heparina de Baixo Peso Molecular/uso terapêutico , Humanos , Incidência , Masculino , Pessoa de Meia-Idade , Femprocumona/uso terapêutico , Tempo de Protrombina , Estudos Retrospectivos , Fatores de Risco , Líquido Sub-RetinianoRESUMO
BACKGROUND: The objective of the study was the investigation of the effects of intravitreal bevacizumab (BEV) with or without additional macular grid laser photocoagulation (GRID) for macular edema (ME) secondary to branch retinal vein occlusion (BRVO). METHODS: Prospective, randomized, monocentric study. Thirty-two patients were included. Initially, all eyes in both groups received three monthly injections of BEV, followed by additional injections if re-treatment criteria were met. In the BEV + GRID group, photocoagulation was performed 2 weeks after the first BEV injection and laser re-treatment was allowed. The follow-up was 38 weeks. Main outcome measures were best-corrected visual acuity (BCVA) and central retinal thickness (CRT). Changes of foveal avascular zone (FAZ) and of retinal ischemia, as well as the number of injections were also evaluated. RESULTS: Sixteen eyes were randomized into each group. At baseline, BCVA was similar in both groups (BEV + GRID: 20/71; BEV: 20/60; P = 0.51). At 38 weeks, BCVA significantly improved in the two groups (BEV + GRID gain of 9 ± 11.2 letters and 16.25 ± 10.08 letters in the BEV) with no difference between them (P < 0.06). With regard to anatomical findings, initial CRT in BEV + GRID was 496.2 µm ± 138.4 µm and 538.9 µm ± 156.9 µm in BEV (P < 0.1697). At 38 weeks, CRT decreased in both groups significantly, 98.2 µm in the BEV + GRID (P = 0.02) and 141.7 µm in the BEV group (P = 0.01), with no significant difference between groups (P < 0.17). The area of FAZ a significantly increased in both groups (41% (P = 0.04) in BEV + GRID; 35% (P = 0.03) in BEV) during the study and the grade of peripheral ischemia remained unchanged. The mean number of injections was 3.8 (range 3-6) with no significant difference between groups. CONCLUSIONS: Our data demonstrate a beneficial effect of bevacizumab in ME in eyes with BRVO. A loading phase of three injections led to a significant improvement in vision in both groups, which persisted at week 38. Additional grid laser photocoagulation exhibited no beneficial functional or anatomical effect during the study, nor did it reduce the number of injections. The FAZ area increased significantly in both groups, but overall retinal ischemia did not. Further studies investigating more numerous eyes and longer follow-up are needed to confirm these data.
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Bevacizumab/administração & dosagem , Fotocoagulação a Laser/métodos , Macula Lutea/patologia , Edema Macular/terapia , Oclusão da Veia Retiniana/complicações , Acuidade Visual , Idoso , Inibidores da Angiogênese/administração & dosagem , Feminino , Angiofluoresceinografia , Seguimentos , Fundo de Olho , Humanos , Injeções Intravítreas , Edema Macular/diagnóstico , Edema Macular/etiologia , Masculino , Estudos Prospectivos , Oclusão da Veia Retiniana/diagnóstico , Oclusão da Veia Retiniana/terapia , Fatores de Tempo , Tomografia de Coerência Óptica , Resultado do Tratamento , Fator A de Crescimento do Endotélio Vascular/antagonistas & inibidoresRESUMO
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.
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Anti-Inflamatórios , Cirurgia Vitreorretiniana , Anti-Inflamatórios/uso terapêutico , Alemanha , Humanos , Procedimentos Cirúrgicos Oftalmológicos , Corpo VítreoRESUMO
Non-arteritic anterior ischemic optic neuropathy (NAION) is an acute neurodegenerative disease with a largely elusive early pathogenesis and no specific therapy. Recent data from animal models of the disease as well as from epidemiological studies have provided new insights into the disease mechanism of NAION. On the basis of this new knowledge, a broad variety of therapeutic approaches is currently being evaluated in animal and clinical studies. This review aims to provide an overview of the pathogenesis as well as neuroprotective therapeutic concepts of recent and currently running studies.
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Doenças Neurodegenerativas , Neuropatia Óptica Isquêmica , Animais , Doenças Neurodegenerativas/etiologia , Doenças Neurodegenerativas/terapia , Neuropatia Óptica Isquêmica/etiologia , Neuropatia Óptica Isquêmica/terapiaRESUMO
Retinal artery occlusion (RAO) should be evaluated as an emergency and can be seen as an ocular analogue to the cerebral apoplex. Both have the same arteriosclerotic risk factors, which are also responsible for cardiac, circulatory and cerebrovascular diseases. That is why an intensive interdisciplinary clarification is necessary to recognize possible comorbidities in time and, if necessary, to treat them. The current therapeutic possibilities of an acute RAO are very limited in their efficiency regarding visual improvement. Methods for systemic lysis cannot be recommended in routine care because of their significantly increased side-effect profile. However, there is a limited window of time of up to 6 hours after the onset of symptoms in which an intervention appears to be useful at all. On the other hand, the new therapeutic possibilities of retinal vein occlusions (RVO) led to marked visual improvements, especially due to the intravitreal application of anti-VEGF. Safety and efficiency of the individual anti-VEGF drugs are comparable according to clinical trials. Alternatively, the use of intravitreal steroids can be considered, whereby the side-effect profile should be carefully weighed. In the presence of retinal ischaemia, peripheral laser coagulation can have a stabilizing effect on visual acuity and prevents neovascularization. It is postulated that the combination of anti-VEGF and laser therapy might have a symbiotic effect.
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Oclusão da Artéria Retiniana , Oclusão da Veia Retiniana , Inibidores da Angiogênese , Bevacizumab , Humanos , Fotocoagulação a Laser , Fator A de Crescimento do Endotélio Vascular/antagonistas & inibidoresRESUMO
PURPOSE: To evaluate the relationship between duration of macular edema associated with retinal vein occlusion (RVO) and the achievement of vision gain in patients receiving dexamethasone intravitreal implant (DEX implant) in real-world clinical practice, and to define patterns of use of DEX implant and its efficacy and safety in the treatment of patients with RVO in clinical practice. METHODS: This prospective, open-label, multicenter, 6-month observational phase IV study conducted at 70 sites in Germany enrolled patients diagnosed with macular edema following branch or central RVO (BRVO, CRVO) who were given DEX implant. Follow-up visits and evaluations occurred in accordance with normal clinical practice. Re-treatment with DEX implant and use of other RVO therapies was at the discretion of the treating physician. The primary endpoint was mean change in best-corrected visual acuity (BCVA) from baseline at week 12. RESULTS: The analysis population consisted of 573 patients (64 % BRVO, 36 % CRVO). Patients received a mean of 1.17 DEX implant treatments during the study period; 84.3 % of patients received a single DEX implant and 19.9 % received adjunctive other RVO treatment. Among patients with analyzable BCVA data at baseline and week 12 (n = 351), mean change from baseline BCVA at week 12 was -0.16 (standard deviation, 0.30) logMAR (+7.8 approximate Early Treatment Diabetic Retinopathy Study [ETDRS] letters) (p < 0.001), and 33.9 % of patients had gained at least 3 lines in BCVA from baseline. Mean change from baseline BCVA at week 12 was +9.5, +7.3, and +5.4 approximate ETDRS letters in patients with macular edema duration < 90 days, from 90 to 180 days, and >180 days respectively. Improvement in BCVA through week 24 and decreases in central retinal thickness were seen in both BRVO and CRVO. The most common adverse drug reaction was increased intraocular pressure. No glaucoma incisional surgeries were required. CONCLUSIONS: DEX implant was effective in improving BCVA and central retinal thickness in patients with BRVO and CRVO in real-world clinical practice. The largest gains in BCVA over 6 months occurred in patients with recent onset macular edema, confirming the benefit of early treatment. DEX implant was well tolerated and had an acceptable safety profile.
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Dexametasona/administração & dosagem , Retina/patologia , Oclusão da Veia Retiniana/tratamento farmacológico , Acuidade Visual , Idoso , Implantes de Medicamento , Seguimentos , Glucocorticoides/administração & dosagem , Humanos , Masculino , Estudos Prospectivos , Retina/efeitos dos fármacos , Oclusão da Veia Retiniana/diagnóstico , Oclusão da Veia Retiniana/fisiopatologia , Fatores de Tempo , Tomografia de Coerência Óptica , Resultado do Tratamento , Corpo VítreoRESUMO
PURPOSE: To identify factors that may lead to a rapid progression in macula-on rhegmatogenous retinal detachment (RRD), in particular, those that may lead to macular involvement. METHODS: Observational, prospective, single-center study. Patients referred for surgery due to primary rhegmatogenous retinal detachment with the macula on between 2009 and 2013 were included. Relevant factors analyzed included age, time delay until surgery, lens status, myopia, the detachment's location and configuration as well as number, size and type of retinal breaks. Eyes underwent optical coherence tomography to detect macular detachment. A multivariate analysis was performed to investigate the effect of several factors in the progression of retinal detachment. RESULTS: A total of 116 eyes of 116 patients were included. Mean time delay between admission and surgery was 1.8 ± 1.4 days. Progression was observed in 19.8% of the eyes. Of those, 47.8% presented macular detachment. Ten of the 11 (90.9%) eyes presenting progression involving the macula also exhibited a bullous configuration, which was the only parameter that correlated significantly with detachment progression in patients with (p = 0.0036) and without (p = 0.0014) macular involvement. CONCLUSIONS: For the first time in a prospective trial, a bullous configuration was found to be a highly significant predictor for progression in macula-on detachments. Our data support prompt surgery in patients diagnosed with bullous macula-on RRD.
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Macula Lutea/patologia , Descolamento Retiniano/diagnóstico , Tomografia de Coerência Óptica/métodos , Acuidade Visual , Progressão da Doença , Feminino , Seguimentos , Humanos , Masculino , Pessoa de Meia-Idade , Estudos Prospectivos , Fatores de RiscoRESUMO
PURPOSE: To evaluate prospectively the efficacy and safety of a fixed bimonthly ranibizumab treatment regimen (RABIMO) in eyes with neovascular age-related macular degeneration (nAMD) and to compare these results with a pro re nata (PRN) treatment scheme. METHODS: This was a 12-month, phase IV, single center, randomised, non-inferiority study. Following three initial monthly injections, patients were randomised to receive either ranibizumab bimonthly (RABIMO group) or ranibizumab PRN (PRN group) (n = 20 each). Main outcome measures were best-corrected visual acuity (BCVA), central retinal thickness (CRT), number of injections, and adverse events (AEs). RESULTS: BCVA [median (interquartile range, IQR)] increased significantly in both groups after 12 months [RABIMO group +8.5 (14); PRN group +6.5 (16) ETDRS letters] when compared to baseline (p < 0.0001; p = 0.0085). At month 12, the RABIMO treatment regimen was non-inferior to the PRN scheme (∆BCVA = 3.5 ETDRS letters; p < 0.0001). CRT was significantly reduced in both groups after the 12-month study period (p < 0.0001 each), with no significant difference between groups (p = 0.6772). Number of overall injections [median (IQR)] was 8 (0) in the RABIMO versus 4 (5) in the PRN group (p = 0.0037). Three patients in the RABIMO group received one additional unscheduled injection. We observed no significant differences between groups in the number of patients with reported SAEs/AEs (RABIMO group n = 6/15; PRN group n = 7/13) (p = 0.7357/p = 0.4902). CONCLUSIONS: We found no evidence of significant functional or anatomical differences between the RABIMO and PRN treatment regimens. However, the RABIMO group's number of injections was twice as high as the PRN group's (protocol-driven). In light of potential side effects, the fixed bimonthly treatment regimen might not be advisable for routine clinical care, but it might be a worthwhile treatment option if monthly monitoring is not possible. Eudra-CT number: 2009-017324-11.
Assuntos
Macula Lutea/patologia , Ranibizumab/administração & dosagem , Tomografia de Coerência Óptica/métodos , Acuidade Visual , Degeneração Macular Exsudativa/tratamento farmacológico , Idoso , Idoso de 80 Anos ou mais , Inibidores da Angiogênese/administração & dosagem , Relação Dose-Resposta a Droga , Esquema de Medicação , Feminino , Seguimentos , Humanos , Injeções Intravítreas , Masculino , Estudos Prospectivos , Fatores de Tempo , Resultado do Tratamento , Degeneração Macular Exsudativa/diagnóstico , Degeneração Macular Exsudativa/fisiopatologiaRESUMO
PURPOSE: Vision loss in central retinal vein occlusion (CRVO) is mostly caused by macular edema (ME) and can be treated with intravitreal bevacizumab injections. The goal of this study was to identify predictive factors for improvement in visual acuity. METHODS: Three hundred and sixteen eyes of six centres having received intravitreal bevacizumab for ME due to CRVO were enrolled in this multicentre, retrospective, interventional case series. The follow-up time was 24 to 48 weeks. Investigated patient characteristics were pretreatment, duration of CRVO prior to the first injection, initial best-corrected visual acuity (BCVA), baseline central retinal thickness as measured by optical coherence tomography, gender, eye, age, comorbidity with glaucoma, systemic hypertension, or diabetes mellitus. RESULTS: Multiple regression analysis confirmed the following baseline predictive factors for an increase in visual acuity: low BCVA (p < 0.001), high CRT (p < 0.02), and treatment naïve patients (p = 0.03). None of the other investigated patient characteristics could be identified as prognostic factors for increase in visual acuity (p > 0.1). CONCLUSIONS: Intravitreal injections of bevacizumab in a routine clinical setting effectively improved and stabilized BCVA in CRVO. Our large multicenter study identified initial BCVA, baseline CRT, and pre-treatment as prognostic factors for visual improvement.