Fluorometholone as Adjunctive Therapy for Trachomatous Trichiasis Surgery

氟米龙作为沙眼倒睫手术的辅助治疗

• 批准号: 10659165
• 负责人: JOHN H KEMPEN
• 金额: $ 54.79万
• 依托单位: MASSACHUSETTS EYE AND EAR INFIRMARY
• 依托单位国家: 美国
• 财政年份: 2019
• 资助国家: 美国
• 起止时间: 2019-09-30 至 2025-06-30
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10659165
• 关键词: Adoption; Adrenal Cortex Hormones; Affect; Anti-Inflammatory Agents; Area; Back; Blindness; Caring; Chronic; Cicatrix; Complication; Contralateral; Cost Effectiveness Analysis; Country; Data; Developing Countries; Dose; Drops; Ethiopia; Eye; Eyedrops; Eyelash; Eyelid structure; Female; Fluorometholone; Generic Drugs; Incidence; Individual; Inflammation; Location; Medical; Modeling; Newly Diagnosed; Operative Surgical Procedures; Ophthalmologist; Outcome; Pain; Pathogenesis; Pathway interactions; Patients; Peer Review; Perioperative; Placebos; Play; Postoperative Period; Poverty; Poverty Areas; Prevalence; Probability; Publishing; Randomized; Recommendation; Recurrence; Regimen; Relapse; Repeat Surgery; Reporting; Resources; Risk; Role; Rotation; Rural; Safety; Scourge; Services; Surgeon; Time; Topical Corticosteroids; Trachoma; Training; Treatment Effectiveness; Vision; Visual impairment; Woman; World Health Organization; active method; chronic pain; clinical trial analysis; comparative efficacy; cost; cost effective; cost effectiveness; dosage; efficacy evaluation; health economics; high risk; incremental cost-effectiveness; male; ocular pain; ocular surface; prevent; programs; randomized trial; treatment group; trial comparing; uptake

Trachoma, the leading infectious cause of blindness in the world, mainly affects the poorest of the poor in endemic areas and females more than males. Trachomatous trichiasis (TT) is a complication of the chronic trachoma-induced scarring, and is a key mechanism leading to blindness from trachoma. For this reason, mass corrective eyelid surgical treatment of TT is a core global programmatic strategy. Presently, there is great programmatic activity globally in carrying out such surgery, which provides the promise of greatly reducing visual impairment including blindness from this ancient scourge. Unfortunately, recurrence of TT after surgery (postoperative TT) is common, probably occurring in over 20% of cases when surgery is performed by integrated eye care worker surgeons trained according to World Health Organization (WHO) recommendations in the programmatic setting. Taking the 20% figure, and the published estimate that 3.2 million need TT surgery, approximately 640,000 cases of postoperative TT will be generated. Postoperative TT is difficult to treat; the WHO recommends referral to an ophthalmologist familiar with the problem when reoperation is needed. However, such ophthalmologist services are seldom available in the remote, impoverished regions affected by trachoma, leaving the large majority of patients with postoperative TT in the predicament of high risk of blindness and pain. Practical strategies to reduce the incidence of postoperative TT hold the potential to reduce low vision and blindness arising from trachoma. Because perioperative topical corticosteroids are effective in limiting postoperative inflammation and scarring for a wide range of ophthalmic surgeries, our group explored the safety and possible benefits of fluorometholone 0.1% eyedrops as ancillary perioperative therapy in a preliminary randomized trial of three candidate doses in comparison with placebo in 154 eyes/upper eyelids of 154 patients with trachoma. Fluorometholone 0.1% is useful for treating local ocular surface inflammation but has poor intraocular effect, which is expected to give a safety advantage when no intraocular effect is wanted. It also is a widely available, low-cost generic drug, which we expect would be feasible to use in a programmatic context. Our preliminary study found an approximate one-third reduction in TT recurrence in the three active treatment groups compared with both placebo-treated eyes and contralateral untreated eyes, with minimal safety issues. To confirm or refute whether adjunctive fluorometholone 0.1% eyedrop treatment would be a programmatically useful strategy worthy of widespread adoption, we propose to conduct a full-scale randomized field trial comparing the efficacy and safety of fluorometholone 0.1% eyedrops twice daily vs. placebo as adjunctive medical therapy for TT surgery. Cost-effectiveness analysis of clinical trial results will guide programs as to the value of the treatment. The study (N=2254 patients) is powered to detect a reduction in postoperative TT from 20% to 15%, an effect threshold corresponding to roughly 160,000 fewer cases of recurrent TT globally with corresponding reductions in blindness risk and chronic pain.

沙眼是世界上失明的主要传染病，主要影响最贫穷的穷人 地方性地区和女性比男性更多。气管斑型（TT）是慢性的并发症 三方瘤引起的疤痕，是导致沙丘瘤失明的关键机制。为此原因， TT的大规模矫正眼睑手术治疗是一种核心的全球程序化策略。目前，有 全球进行此类手术的伟大程序化活动，这提供了极大的承诺 减少视觉障碍，包括从这种古老的祸害中失明。不幸的是，tt之后的复发 手术（术后TT）很常见，可能发生在超过20％的病例中 根据世界卫生组织（WHO）建议培训的综合眼保健工作者 在程序设置中。以20％的数字为单位，并估计有320万个需要TT 手术，将产生大约640,000例术后TT病例。术后TT很难 对待; WHO建议转介给熟悉此问题的眼科医生 需要。但是，这种眼科医生的服务很少在遥远的贫困地区提供 受沙眼瘤的影响，使大多数术后TT患者处于较高的困境 失明和疼痛的风险。减少术后TT发生率的实用策略有可能 减少沙质瘤引起的低视力和失明。因为围手术期局部皮质类固醇是 有效地限制术后炎症并为多种眼科手术造成疤痕 探索了荧光甲酮0.1％眼药的安全性和可能的​​好处 与安慰剂相比，在154眼/上的安慰剂的初步随机试验中 154例沙眼患者的眼睑。氟乙酮0.1％可用于治疗局部眼表 炎症，但眼内作用较差，当没有眼内时，这将带来安全优势 想要效果。这也是一种广泛可用的低成本通用药物，我们希望使用它是可行的 在程序上的环境中。我们的初步研究发现，TT复发的大约三分之一 与安慰剂治疗的眼睛和对侧未处理的眼睛相比，这三个主动治疗组相比 有最小的安全问题。确认或驳斥辅助荧光素酮是否0.1％EyEdrop治疗 我们将是一个有用的有用的策略，值得广泛采用，我们建议进行全面进行 随机现场试验比较了氟乙醇酮0.1％眼龙的功效和安全性，每天两次VS。 安慰剂作为TT手术的辅助药物治疗。临床试验结果的成本效益分析将 指导治疗价值的计划。该研究（n = 2254名患者）有动力检测减少 在术后TT中，从20％到15％，效果阈值对应于大约160,000例较少的病例 全球循环TT，相应减少失明风险和慢性疼痛。