Academic Unit of Ophthalmology, Institute of Inflammation and Ageing, University of Birmingham, Birmingham and Midland Eye Centre, City Hospital, Dudley Road, Birmingham, B18 7QU, UK.
Institute of Clinical Sciences, College of Medical and Dental Sciences, University of Birmingham, Edgbaston, Birmingham, B15 2TT, UK.
Syst Rev. 2020 Mar 12;9(1):54. doi: 10.1186/s13643-020-01314-9.
Non-infectious scleritis is a potentially sight-threatening condition in which the sclera, the white outer layer of the eye, becomes inflamed. Whilst scleritis can be infective, the majority of cases are due to non-infectious causes, often occurring in association with an underlying systemic autoimmune or auto-inflammatory condition. Thorough systemic work-up is crucial to identify disease aetiology and exclude infection; however, a significant proportion of disease remains idiopathic with the underlying cause unknown. Non-infectious scleritis is normally managed with systemic corticosteroid and immunosuppression, yet there is no widely agreed consensus on the most appropriate therapy, and no national or international guidelines exist for treatment of non-infectious scleritis.
Standard systematic review methodology will be used to identify, select and extract data from comparative studies of pharmacological interventions used to treat patients with non-infectious scleritis. Searches of bibliographic databases (Cochrane Library, MEDLINE, CINAHL and EMBASE) and clinical trial registers will be employed. No restrictions will be placed on language or date of publication. Non-English articles will be translated where necessary. The primary outcome of interest will be disease activity measured by reduction in scleritis grading according to standardised grading systems. Secondary outcomes will include change in best corrected visual acuity, reduction in concurrent dose of systemic corticosteroid, time to treatment failure, adverse events and health-related quality of life. Risk of bias assessment will be conducted appropriate to each study design. Study selection, data extraction and risk of bias assessment will be completed by two reviewers independently. Data will be presented in a table and a narrative synthesis will be undertaken. Meta-analysis will be performed where methodological and clinical homogeneity exists. Subgroup and sensitivity analysis will be undertaken if appropriate.
Many studies have investigated the effectiveness of pharmacological agents used in the management of non-infectious scleritis. A systematic review is needed to collate and analyse this evidence. Findings of this systematic review will help guide ophthalmologists managing patients with non-infectious scleritis and may form the basis for evidence-based recommendations for future clinical practice and encourage standardisation of treatment protocols.
PROSPERO CRD42019125198.
非感染性巩膜炎是一种潜在的致盲性疾病，巩膜是眼球的白色外层，会发生炎症。虽然巩膜炎可能是感染性的，但大多数病例是由非感染性原因引起的，通常与潜在的系统性自身免疫或自身炎症性疾病有关。彻底的系统检查对于确定疾病病因和排除感染至关重要；然而，仍有相当一部分疾病是特发性的，其根本原因尚不清楚。非感染性巩膜炎通常采用全身性皮质类固醇和免疫抑制治疗，但对于最适当的治疗方法尚未达成广泛共识，也没有针对非感染性巩膜炎的治疗的国家或国际指南。
将采用标准系统评价方法，从用于治疗非感染性巩膜炎患者的药物干预比较研究中识别、选择和提取数据。将检索书目数据库（Cochrane 图书馆、MEDLINE、CINAHL 和 EMBASE）和临床试验登记处。不限制语言或发表日期。必要时将翻译非英语文章。主要观察结果将是根据标准化分级系统评估的巩膜炎分级降低来衡量的疾病活动度。次要结果将包括最佳矫正视力的变化、全身皮质类固醇剂量的降低、治疗失败的时间、不良事件和健康相关生活质量。将根据每个研究设计适当进行偏倚风险评估。研究选择、数据提取和偏倚风险评估将由两名独立的评审员完成。将在表格中呈现数据，并进行叙述性综合。如果存在方法学和临床同质性，将进行荟萃分析。如果适当，将进行亚组和敏感性分析。
许多研究已经调查了用于治疗非感染性巩膜炎的药物的有效性。需要进行系统评价来整理和分析这些证据。这项系统评价的结果将有助于指导眼科医生治疗非感染性巩膜炎患者，并可能为未来的临床实践提供循证建议，并鼓励治疗方案的标准化。
PROSPERO CRD42019125198。
