Developments in ophthalmology最新文献

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Emerging Issues for Ultra-Wide Field Angiography. 超宽场血管造影新出现的问题。
Developments in ophthalmology Pub Date : 2017-01-01 Epub Date: 2017-04-20 DOI: 10.1159/000459689
Alessandro Rabiolo, Luigi Antonio De Vitis, Riccardo Sacconi, Adriano Carnevali, Lea Querques, Francesco Bandello, Giuseppe Querques
{"title":"Emerging Issues for Ultra-Wide Field Angiography.","authors":"Alessandro Rabiolo,&nbsp;Luigi Antonio De Vitis,&nbsp;Riccardo Sacconi,&nbsp;Adriano Carnevali,&nbsp;Lea Querques,&nbsp;Francesco Bandello,&nbsp;Giuseppe Querques","doi":"10.1159/000459689","DOIUrl":"https://doi.org/10.1159/000459689","url":null,"abstract":"<p><p>Fluorescein angiography (FA) is a useful test in patients affected by diabetic retinopathy (DR) to evaluate the blood-retinal barrier integrity and the presence of non-perfused areas, vascular leakage, microvascular abnormalities, and neovascularization. The peripheral retina is involved in most DR lesions, and, thus, its proper visualization is crucial for the screening, diagnosis, monitoring, treatment, and prognosis of DR. To expand the field of view, wide-field and ultra-wide-field imaging have been developed, allowing images up to 200° of retinal surface in one single photo. In this chapter, emerging issues concerning ultra-wide-field FA in DR are illustrated.</p>","PeriodicalId":77107,"journal":{"name":"Developments in ophthalmology","volume":"60 ","pages":"50-55"},"PeriodicalIF":0.0,"publicationDate":"2017-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.1159/000459689","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"34928608","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 2
Practical Lessons from Protocol I for the Management of Diabetic Macular Edema. 糖尿病性黄斑水肿治疗方案I的实践经验。
Developments in ophthalmology Pub Date : 2017-01-01 Epub Date: 2017-04-20 DOI: 10.1159/000459692
Lekha Mukkamala, Neelakshi Bhagat, Marco A Zarbin
{"title":"Practical Lessons from Protocol I for the Management of Diabetic Macular Edema.","authors":"Lekha Mukkamala,&nbsp;Neelakshi Bhagat,&nbsp;Marco A Zarbin","doi":"10.1159/000459692","DOIUrl":"https://doi.org/10.1159/000459692","url":null,"abstract":"<p><p>Protocol I, a multicenter randomized clinical trial, compared the visual outcomes of patients treated with 0.5 mg intravitreal ranibizumab with either prompt or deferred (by 24 weeks laser), 4 mg intravitreal triamcinolone with prompt laser, or sham injection with prompt laser for the treatment of center-involving diabetic macular edema (DME). A total of 854 adult patients with type I or II diabetes and any level of non-proliferative diabetic retinopathy or proliferative retinopathy with adequate panretinal photocoagulation, with best-corrected visual acuity (BCVA) of 78 to 24 ETDRS letters (Snellen equivalent of 20/32 to 20/320) and visual loss attributed to macular edema, or retinal thickening with central subfield thickness of at least 250 µm by OCT were enrolled. The main outcomes relevant for practicing clinicians are as follows. (1) Intravitreal ranibizumab treatment provides superior visual outcomes compared to conventional laser treatment. (2) Adjunctive laser treatment does not appear to provide substantial visual benefit compared to ranibizumab treatment alone, but may reduce the number of injections required to resolve DME. Deferral of laser is likely beneficial in patients with worse initial visual acuity. (3) Intravitreal triamcinolone provides similar visual outcomes compared to intravitreal ranibizumab in pseudophakic patients but is associated with a clinically important increased risk of increased intraocular pressure (IOP), need for glaucoma medications, and need for glaucoma surgery. (4) Delayed initiation of intravitreal ranibizumab therapy provides improved visual outcome among patients initially treated with conventional laser photocoagulation or triamcinolone, but the magnitude of the benefit is not as great as is observed when ranibizumab treatment is initiated promptly. (5) The number of ranibizumab injections required to achieve the desired visual outcome decreases substantially after the first year, with the majority of patients not requiring further treatment after 3 years. (6) Patients who do not have a rapid response to ranibizumab still display long-term benefit to continued therapy, although perhaps less than those with immediate improvement. (7) Intravitreal ranibizumab is not only effective in reducing retinal edema and improving BCVA among patients with DME, it is also a disease modifying therapy and induces improvement of the diabetic retinopathy severity score by 2 or more steps in approximately one third of patients. Triamcinolone injection also induces improvement in diabetic retinopathy severity in DME patients, but perhaps to a lesser degree. (8) No increased risk of systemic adverse events was observed among patients treated with intravitreal ranibizumab compared to sham-injected controls or triamcinolone-treated patients, but the low frequency of adverse events, restrictive enrollment criteria, and specific posology employed in this study limit the generalization of this conclusion to patients rout","PeriodicalId":77107,"journal":{"name":"Developments in ophthalmology","volume":"60 ","pages":"91-108"},"PeriodicalIF":0.0,"publicationDate":"2017-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.1159/000459692","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"34928613","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 10
Anti-Vascular Endothelial Growth Factor Injections: The New Standard of Care in Proliferative Diabetic Retinopathy? 抗血管内皮生长因子注射:增殖性糖尿病视网膜病变的新护理标准?
Developments in ophthalmology Pub Date : 2017-01-01 Epub Date: 2017-04-20 DOI: 10.1159/000459699
Xintong Li, Marco A Zarbin, Neelakshi Bhagat
{"title":"Anti-Vascular Endothelial Growth Factor Injections: The New Standard of Care in Proliferative Diabetic Retinopathy?","authors":"Xintong Li,&nbsp;Marco A Zarbin,&nbsp;Neelakshi Bhagat","doi":"10.1159/000459699","DOIUrl":"https://doi.org/10.1159/000459699","url":null,"abstract":"<p><p>For decades, panretinal photocoagulation (PRP) has been the standard of care for the treatment of proliferative diabetic retinopathy (PDR). The relatively recent advent of anti-vascular endothelial growth factor (VEGF) formulations for intravitreal injection has provided a fresh perspective on PDR treatment, especially in eyes with concurrent diabetic macular edema (DME). The anti-VEGF agent ranibizumab has demonstrated a potentially protective effect on eyes with DME in terms of progression to PDR in the RIDE/RISE trials, as has aflibercept in the VIVID/VISTA trials. In 2015, these 2 agents were approved by the Food and Drug Administration for the treatment of PDR with DME, though PRP still remains the standard of care for eyes without baseline DME. Published results from Protocol S illustrate the non-inferiority of ranibizumab versus PRP in the treatment of PDR, the first prospective study to do so in eyes with and without baseline DME. These results also reveal that treatment with ranibizumab, when compared to standard treatment with PRP, may also lead to less peripheral visual field loss, reduced need for vitrectomy, and reduced chance for developing DME. Both PRP and intravitreal ranibizumab have very low rates of adverse events. However, treatment with anti-VEGF agents generally is associated with higher costs, increased need for follow-up, and the risk of potentially catastrophic ocular complications (e.g., endophthalmitis) and systemic side effects. Anti-VEGF agents should be considered in cases of media opacity preventing completion of PRP in compliant patients without recent cerebrovascular accident or myocardial infarction, though the long-term efficacy of these agents remains to be studied, especially after the discontinuation of injections.</p>","PeriodicalId":77107,"journal":{"name":"Developments in ophthalmology","volume":"60 ","pages":"131-142"},"PeriodicalIF":0.0,"publicationDate":"2017-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.1159/000459699","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"34928019","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 25
Intravitreal Ranibizumab in Diabetic Macular Edema: Long-Term Outcomes. 玻璃体内注射雷尼单抗治疗糖尿病黄斑水肿:长期结果。
Developments in ophthalmology Pub Date : 2017-01-01 Epub Date: 2017-04-20 DOI: 10.1159/000460496
Ilaria Zucchiatti, Francesco Bandello
{"title":"Intravitreal Ranibizumab in Diabetic Macular Edema: Long-Term Outcomes.","authors":"Ilaria Zucchiatti,&nbsp;Francesco Bandello","doi":"10.1159/000460496","DOIUrl":"https://doi.org/10.1159/000460496","url":null,"abstract":"<p><p>Intravitreal ranibizumab (RBZ) has been shown in multiple randomized clinical trials to be a valuable treatment for diabetic macular edema (DME), promoting a significant improvement in best-corrected visual acuity (BCVA) and in anatomic outcomes. Compared to sham (RISE and RIDE studies), RBZ rapidly and sustainably improved BCVA and decreased macular edema at 2 years, reducing the risk of further vision loss, with low rates of local or systemic side effects. Compared to macular laser photocoagulation (READ-2 study), RBZ provided a greater improvement in BCVA and regression in foveal thickness, but required a higher number of injections compared to patients treated with both RBZ and laser. In RESTORE trial, RBZ alone or combined with macular laser turned out to be superior to laser alone, without significant differences between the 2 RBZ groups. Compared to combined treatment (RBZ or triamcinolone associated with macular laser) or photocoagulation laser alone (Diabetic Retinopathy Clinical Research Network trial), RBZ with prompt or deferred laser was more effective than laser alone at 1-year follow-up. At 3 years, prompt laser was not better than deferring laser for 24 weeks or more. At 5 years, subjects treated with RBZ achieved better long-term visual outcomes than patients managed with triamcinolone or laser followed by very deferred RBZ. In conclusion, randomized clinical trials showed that RBZ was superior to laser in DME treatment, providing excellent long-term visual outcomes. Frequent injections were necessary in most of the patients to properly control DME and maximize the visual benefits.</p>","PeriodicalId":77107,"journal":{"name":"Developments in ophthalmology","volume":"60 ","pages":"63-70"},"PeriodicalIF":0.0,"publicationDate":"2017-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.1159/000460496","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"34928610","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 6
Management of Concomitant Cataract and Glaucoma. 并发性白内障和青光眼的处理。
Developments in ophthalmology Pub Date : 2017-01-01 Epub Date: 2017-04-25 DOI: 10.1159/000458494
Giorgio Marchini, Piero Ceruti, Gabriele Vizzari, Davide Berzaghi, Andrea Zampieri
{"title":"Management of Concomitant Cataract and Glaucoma.","authors":"Giorgio Marchini,&nbsp;Piero Ceruti,&nbsp;Gabriele Vizzari,&nbsp;Davide Berzaghi,&nbsp;Andrea Zampieri","doi":"10.1159/000458494","DOIUrl":"https://doi.org/10.1159/000458494","url":null,"abstract":"<p><p>The coexistence of cataract and glaucoma represents a challenge for the ophthalmologist and the issue is still open to debate. The surgical management is based on both the visual field defect and the loss of visual acuity. The surgical options currently available are: (1) cataract extraction alone, (2) sequential glaucoma surgery and cataract extraction, and (3) combined surgery by 1 site or by 2 separate sites. Phacoemulsification alone is suggested when glaucoma can be controlled by medication and the visual field defect is moderate and nonprogressive. In case of a refractory glaucoma (3 or more types of medication required) with associated early-stage cataract, phacoemulsification could be postponed until after glaucoma surgery. The cataractogenous effect of the procedure should be considered in this situation. Moreover, cataract extraction performed after a filtering surgery may lead to a reduction of the bleb function. When both glaucoma and cataract are sight impairing, combined surgery is indicated since it allows a greater intraocular pressure decrease than phacoemulsification alone.</p>","PeriodicalId":77107,"journal":{"name":"Developments in ophthalmology","volume":"59 ","pages":"155-164"},"PeriodicalIF":0.0,"publicationDate":"2017-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.1159/000458494","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"34942208","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 22
Macular Edema: Definition and Basic Concepts. 黄斑水肿:定义和基本概念。
Developments in ophthalmology Pub Date : 2017-01-01 Epub Date: 2017-03-28 DOI: 10.1159/000455264
Gabriel Coscas, José Cunha-Vaz, Gisèle Soubrane
{"title":"Macular Edema: Definition and Basic Concepts.","authors":"Gabriel Coscas,&nbsp;José Cunha-Vaz,&nbsp;Gisèle Soubrane","doi":"10.1159/000455264","DOIUrl":"https://doi.org/10.1159/000455264","url":null,"abstract":"<p><p>Macular edema is the result of an accumulation of fluid in the retinal layers around the fovea. It contributes to vision loss by altering the functional cell relationship in the retina and promoting an inflammatory reparative response. Macular edema may be intracellular or extracellular. Intracellular accumulation of fluid, also called cytotoxic edema, is an alteration of the cellular ionic distribution. Extracellular accumulation of fluid, which is more frequent and clinically more relevant, is directly associated with an alteration of the blood-retinal barrier (BRB). The following parameters are relevant for clinical evaluation of macular edema: extent of the macular edema (i.e., the area that shows increased retinal thickness); distribution of the edema in the macular area (i.e., focal versus diffuse macular edema); central foveal involvement (central area 500 μm); fluorescein leakage (evidence of alteration of the BRB or 'open barrier') and intraretinal cysts; signs of ischemia (broken perifoveolar capillary arcade and/or areas of capillary closure); presence or absence of vitreous traction; increase in retinal thickness and cysts in the retina (inner or outer), and chronicity of the edema (i.e., time elapsed since initial diagnosis and response to therapy). It is essential to establish associations and correlations of all the different images obtained, regardless of whether the same or different modalities are used.</p>","PeriodicalId":77107,"journal":{"name":"Developments in ophthalmology","volume":"58 ","pages":"1-10"},"PeriodicalIF":0.0,"publicationDate":"2017-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.1159/000455264","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"34862629","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 47
Retinitis Pigmentosa and Other Dystrophies. 色素性视网膜炎和其他营养不良。
Developments in ophthalmology Pub Date : 2017-01-01 Epub Date: 2017-03-28 DOI: 10.1159/000455281
Sarah Mrejen, Isabelle Audo, Sébastien Bonnel, José-Alain Sahel
{"title":"Retinitis Pigmentosa and Other Dystrophies.","authors":"Sarah Mrejen,&nbsp;Isabelle Audo,&nbsp;Sébastien Bonnel,&nbsp;José-Alain Sahel","doi":"10.1159/000455281","DOIUrl":"https://doi.org/10.1159/000455281","url":null,"abstract":"<p><p>Retinitis pigmentosa (RP) is a heterogeneous group of inherited retinal degenerations characterized by progressive degeneration of rod and cone cells that affects predominantly peripheral visual fields. Macular edema may cause additional central visual acuity decrease. Cystoid macular edema (CME) is one of the few treatable causes of visual loss in RP. The prevalence of CME in RP has been found to be between 10 and 20% on fluorescein angiography-based studies, and as high as 49% on reports based on optical coherence tomography. Macular edema can manifest at any stage of the disease and may be unilateral or bilateral. It can be found in any genetic form, but is more often associated with RP caused by CRB1 mutations. The origin of macular edema in RP patients still remains poorly understood. Some mechanisms have been suggested, including antiretinal antibodies (retinal, carbonic anhydrase, and enolase antibodies), vitreous traction, retinal pigment epithelium dysfunction, and Müller cell edema. There is no gold standard therapeutic strategy. Drug therapy is the primary treatment. Systemic carbonic anhydrase inhibitors, such as oral acetazolamide or topical dorzolamide, are still the mainstays of initial therapy. If CME is refractory to acetazolamide, intravitreal corticosteroid injections may be a therapeutic option. However, antivascular endothelium growth factor injections have limited effect and should be avoided. Vitrectomy has also been evaluated, but its exact role remains to be determined. The benefits of these therapies are variable among patients. The establishment of therapeutic approaches is limited by our poor understanding of the pathophysiology of CME in patients with RP. Autoimmune retinopathies (AIRs) are a group of rare diseases characterized by acute or subacute progressive vision loss and are thought to be mediated by autoantibodies specific to retinal antigens. The AIRs encompass paraneoplastic syndromes, such as cancer-associated retinopathy and melanoma-associated retinopathy, and a larger group of AIRs that have similar clinical and immunological findings but without underlying malignancy. These diseases may also be complicated by macular edema. RP is one of the most common forms of inherited retinal degeneration. It displays extensive clinical and genetic variations and leads to progressive blindness with variable onset.</p>","PeriodicalId":77107,"journal":{"name":"Developments in ophthalmology","volume":"58 ","pages":"191-201"},"PeriodicalIF":0.0,"publicationDate":"2017-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.1159/000455281","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"34862637","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 12
Intracellular Edema. 细胞内水肿。
Developments in ophthalmology Pub Date : 2017-01-01 Epub Date: 2017-03-28 DOI: 10.1159/000455266
Raja Narayanan, Baruch D Kuppermann
{"title":"Intracellular Edema.","authors":"Raja Narayanan,&nbsp;Baruch D Kuppermann","doi":"10.1159/000455266","DOIUrl":"https://doi.org/10.1159/000455266","url":null,"abstract":"<p><p>The macula is predisposed to edema in various retinal conditions, even when the insult is remote from the macula. The various factors that may predispose the macula to edema include high metabolic activity, radial arrangement of the Henle's layer, lack of inner layers at the fovea, and lack of blood supply at the fovea. The edema is most pronounced in the outer plexiform layer (Henle's layer). Alteration in the blood-retinal barrier and ischemia cause disturbances in vascular permeability as well as with the function of Müller cells. K+ ions and aquaporin-4 play an important role in maintaining the dryness of the macula in physiological conditions. Intracellular edema of Müller cells contributes significantly to macular edema. Steroids and anti-VEGF agents reduce intracellular edema, apart from extracellular edema. Therapeutic targets for improving Müller cell function could play a key role in the development of new molecules.</p>","PeriodicalId":77107,"journal":{"name":"Developments in ophthalmology","volume":"58 ","pages":"21-26"},"PeriodicalIF":0.0,"publicationDate":"2017-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.1159/000455266","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"34862631","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 3
Ab interno Schlemm's Canal Surgery. 施勒姆氏管手术。
Developments in ophthalmology Pub Date : 2017-01-01 Epub Date: 2017-04-25 DOI: 10.1159/000458492
Brian A Francis, Handan Akil, Benjamin B Bert
{"title":"Ab interno Schlemm's Canal Surgery.","authors":"Brian A Francis,&nbsp;Handan Akil,&nbsp;Benjamin B Bert","doi":"10.1159/000458492","DOIUrl":"https://doi.org/10.1159/000458492","url":null,"abstract":"<p><p>In primary open-angle glaucoma, the site of greatest resistance to aqueous outflow is thought to be the trabecular meshwork (TM) and inner wall of Schlemm's canal. Augmentation of the conventional (trabecular) outflow pathway can facilitate physiologic outflow and subsequently lower intraocular pressure. The most recent approach to enhancing the conventional outflow pathway is via an internal approach to the TM and Schlemm's canal. Ab interno Schlemm's canal surgery includes 4 novel surgical approaches: (1) removal of the TM and inner wall of Schlemm's canal by an internal approach (ab interno trabeculectomy), (2) implantation of a microstent to bypass the TM, (3) disruption of the TM and inner wall of Schlemm's canal via an internal approach (ab interno trabeculotomy), and (4) dilation of Schlemm's canal via an internal approach (ab interno canaloplasty). The first category includes the Trabectome (Neomedix, Tustin, CA, USA), and Kahook Dual Blade (New World Medical, Rancho Cucamonga, CA, USA). The second category includes the iStent (Glaukos, Laguna Hills, CA, USA), as well as the investigational Hydrus Microstent implant (Ivantis, Irvine, CA, USA). The third category includes gonioscopic-assisted transluminal trabeculotomy (iSciences catheter; Ellex, Adelaide, Australia), and 360° suture trabeculotomy (TRAB360, Sight Sciences, Menlo Park, CA, USA). The fourth category includes ab interno canaloplasty or AbiC (Ellex), and Visco360 (Sight Sciences). In contrast to external filtration surgeries, such as trabeculectomy and aqueous tube shunt, these procedures are categorized as internal filtration surgeries and are performed from an internal approach via gonioscopic guidance. Published results suggest that these surgical procedures are both safe and efficacious for the treatment of open-angle glaucoma.</p>","PeriodicalId":77107,"journal":{"name":"Developments in ophthalmology","volume":"59 ","pages":"127-146"},"PeriodicalIF":0.0,"publicationDate":"2017-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.1159/000458492","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"34942206","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 31
Application of Clinical Trial Results to Clinical Practice. 临床试验结果在临床实践中的应用。
Developments in ophthalmology Pub Date : 2017-01-01 Epub Date: 2017-04-20 DOI: 10.1159/000459707
Marco A Zarbin, Neelakshi Bhagat, Lekha K Mukkamala
{"title":"Application of Clinical Trial Results to Clinical Practice.","authors":"Marco A Zarbin,&nbsp;Neelakshi Bhagat,&nbsp;Lekha K Mukkamala","doi":"10.1159/000459707","DOIUrl":"https://doi.org/10.1159/000459707","url":null,"abstract":"<p><p>Two critical questions one must answer as one applies the results of a clinical trial to clinical practice are: (1) Regardless of whether the trial result is likely to be replicated or reproduced in a second large-scale trial, are the results likely to be reproduced in one's practice? (2) Regardless of whether the experimental treatment was better than the alternative on average for a population of patients, are the results clinically important for a given patient in one's practice? To determine if a study result is likely to be reproduced in one's clinical practice, it may be helpful to answer 5 questions: (1) Have steps been taken to minimize bias? (2) Is the result likely due to the treatment? (3) Is the result unlikely due to chance? (4) Is the study population representative of one's patients? (5) Is the totality of evidence consistent? If the answer to all 5 questions is \"yes,\" then we posit that the trial result is likely to be reproduced in one's practice. If not, the likelihood of reproducibility is low. If the answer is yes to all questions except the last, then reproducibility in one's practice is not clear and depends on the strength of the prior versus the current evidence. If the prior evidence is strong, such as multiple pivotal randomized clinical trials, and if the current trial result is not consistent with the previous studies, then the current result may not be reproduced in one's practice. To determine if a study result is clinically important, a 3-step approach is suggested. Step 1. Decide, a priori, what a clinically meaningful difference between 2 treatments would be. This choice defines regions of beneficial, harmful, and trivial outcomes. Step 2. Identify the confidence intervals (CIs). Determine whether the 95% CI mostly includes the range of clinically beneficial outcomes and lies outside the range of clinically harmful outcomes. If these conditions are met, the result is probably clinically important, but the result may or may not be statistically significant. Put the CIs and the regions of benefit/harm together to make a decision about clinically important effects. Step 3. Assess the proportion of eyes with clinically meaningful changes in vision. The proportion of \"responders\" among patients receiving a given treatment reflects the likelihood of one's patient having a clinically meaningful response to the treatment. In summary, not all statistically significant results are reproduced, even those of carefully designed clinical trials. Determining if a study result is likely to be reproduced in one's practice is even more problematic. The 5-question test may help in this regard. The 5-question test attempts to assess whether steps have been taken to: minimize bias; avoid confounding; ensure adequate statistical power to support precision in the estimates of population parameters; insure external validity of the trial result; and determine whether there is a convergence of evidence consistent with the trial's maj","PeriodicalId":77107,"journal":{"name":"Developments in ophthalmology","volume":"60 ","pages":"175-189"},"PeriodicalIF":0.0,"publicationDate":"2017-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.1159/000459707","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"34928023","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 1
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