Evaluating the efficacy and safety of therapeutic interventions for corneal neuropathy: A systematic review

IF 5.9 1区 医学 Q1 OPHTHALMOLOGY
Rajni Rajan, Eve Makrai, Ji-hyun Lee, Sumeer Singh, Holly R. Chinnery, Laura E. Downie
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引用次数: 0

Abstract

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.

评估角膜神经病变治疗干预措施的有效性和安全性:系统综述。
角膜神经病变是指角膜神经受损,从而破坏了眼表的完整性,并因疼痛和视力受损而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性疾病都可能导致角膜神经病变。然而,这种病症目前还没有标准化的诊断标准或治疗方案。本系统综述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方法的随机对照试验(RCT),如果干预措施与安慰剂或活性比较物进行了比较,则符合条件。我们在 Ovid MEDLINE、Ovid Embase 和临床试验登记处进行了全面检索,检索时间从开始到 2022 年 7 月。采用 Cochrane Risk-of-Bias 2 工具评估研究的方法学质量。采用建议评估、发展和评价分级法(GRADE)评估证据的确定性。总共纳入了 20 项 RCT。评估的干预措施包括再生疗法(6 项研究)、膳食补充剂(4 项研究)、降糖药物(3 项研究)、综合疗法(3 项研究)、支持疗法(2 项研究)和系统性疼痛药物疗法(2 项研究)。在大多数结果中,有九项 RCT 被判定为偏倚风险较高。不同研究对角膜神经病变的定义差异很大,这与诊断标准缺乏共识相一致。量化的结果多种多样,这可能反映出缺乏一致认可的核心结果。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结论。对于改善干眼症和糖尿病引起的角膜神经病变的角膜神经纤维长度,几种神经再生制剂和膳食补充剂均有低度或极低度确定性证据。对于不改变角膜免疫细胞密度的神经再生疗法和膳食补充剂,发现了低度或极低度确定性证据。本综述指出,有必要对角膜神经病变的临床定义进行标准化,并定义一套最低限度的核心结果衡量标准。这将为改善研究中临床人群的表型奠定基础,并提高综合数据的能力,为循证治疗提供依据。协议注册:PROSPERO ID:CRD42022348475。
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来源期刊
Ocular Surface
Ocular Surface 医学-眼科学
CiteScore
11.60
自引率
14.10%
发文量
97
审稿时长
39 days
期刊介绍: The Ocular Surface, a quarterly, a peer-reviewed journal, is an authoritative resource that integrates and interprets major findings in diverse fields related to the ocular surface, including ophthalmology, optometry, genetics, molecular biology, pharmacology, immunology, infectious disease, and epidemiology. Its critical review articles cover the most current knowledge on medical and surgical management of ocular surface pathology, new understandings of ocular surface physiology, the meaning of recent discoveries on how the ocular surface responds to injury and disease, and updates on drug and device development. The journal also publishes select original research reports and articles describing cutting-edge techniques and technology in the field. Benefits to authors We also provide many author benefits, such as free PDFs, a liberal copyright policy, special discounts on Elsevier publications and much more. Please click here for more information on our author services. Please see our Guide for Authors for information on article submission. If you require any further information or help, please visit our Support Center
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