角膜神经病涉及角膜神经损伤,破坏眼表完整性,疼痛和视力受损对生活质量产生负面影响。任何损害三叉神经的眼部或全身状况都可导致角膜神经病变。然而,该疾病目前没有标准化的诊断标准或治疗方案.本系统评价的主要目的是评估治疗角膜神经病的干预措施的有效性和安全性。研究角膜神经病变治疗的随机对照试验(RCT)是合格的,如果干预措施与安慰剂或活性比较比较。在OvidMEDLINE进行了全面搜索,OvidEmbase和临床试验注册中心从成立到2022年7月。Cochrane偏差风险2工具用于评估研究方法学质量。使用建议分级评估来评估证据的确定性,开发和评估(等级)方法。总的来说,包括20项RCT。评估的干预措施包括再生疗法(n=6项研究),膳食补充剂(n=4),抗血糖药(n=3),联合治疗(n=3),支持治疗(n=2)和全身疼痛药物治疗(n=2)。对于大多数结果,9项随机对照试验被判定为偏倚风险高。人群角膜神经病变的定义在研究中差异很大,与诊断标准缺乏共识一致。量化了各种各样的结果,可能反映缺乏商定的核心成果。没有足够的证据就任何干预措施的有效性或安全性得出明确的结论。在干眼症和糖尿病引起的角膜神经病中,有几种神经再生剂和膳食补充剂改善角膜神经纤维长度的确定性低或非常低的证据。发现神经再生疗法和膳食补充剂不改变角膜免疫细胞密度的低或非常低的确定性证据。这篇综述确定了标准化角膜神经病的临床定义并定义一组最小核心结果指标的必要性。一起,这将为在研究中改善临床人群的表型奠定基础,并提高综合数据的能力,为循证护理提供信息。协议注册:PROSPEROID:CRD42022348475。
Corneal neuropathy involves corneal nerve damage that disrupts ocular surface integrity, negatively impacting quality-of-life from pain and impaired vision. Any ocular or systemic condition that damages the trigeminal nerve can lead to corneal neuropathy. However, the condition currently does not have standardized diagnostic criteria or treatment protocols. The primary aim of this systematic
review was to evaluate the efficacy and safety of interventions for treating corneal neuropathy. Randomized controlled trials (RCTs) that investigated corneal neuropathy treatments were eligible if the intervention(s) was compared to a placebo or active comparator. Comprehensive searches were conducted in Ovid MEDLINE, Ovid Embase and clinical trial registries from inception to July 2022. The Cochrane Risk-of-Bias 2 tool was used to assess study methodological quality. Certainty of the body of evidence was assessed using the Grading of Recommendations Assessment, Development and Evaluation (GRADE) approach. Overall, 20 RCTs were included. Evaluated interventions comprised regenerative therapies (n = 6 studies), dietary supplements (n = 4), anti-glycemic agents (n = 3), combination therapy (n = 3), supportive therapies (n = 2) and systemic pain pharmacotherapies (n = 2). Nine RCTs were judged at high risk of bias for most outcomes. Definitions for corneal neuropathy in the populations varied substantially across studies, consistent with lack of consensus on diagnostic criteria. A diverse range of outcomes were quantified, likely reflecting absence of an agreed core outcome set. There was insufficient evidence to draw definitive conclusions on the efficacy or safety of any intervention. There was low or very low certainty evidence for several neuroregenerative agents and dietary supplements for improving corneal nerve fiber length in corneal neuropathy due to dry eye disease and diabetes. Low or very low certainty evidence was found for neuroregenerative therapies and dietary supplements not altering corneal immune cell density. This
review identifies a need to standardize the clinical definition of corneal neuropathy and define a minimum set of core outcome measures. Together, this will provide a foundation for improved phenotyping of clinical populations in studies, and improve the capacity to synthesize data to inform evidence-based care. Protocol registration: PROSPERO ID: CRD42022348475.