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临床试验/NCT07247071
NCT07247071已完成不适用

Modifiable Risk Factors for Non-traumatic Subconjunctival Hemorrhage

Hallym University Kangnam Sacred Heart Hospital1 个研究点 分布在 1 个国家目标入组 67 人开始时间: 2022年12月22日最近更新:

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
67
试验地点
1
主要终点
Subconjunctival hemorrhage

研究概览

简要总结

Subconjunctival hemorrhage (SCH) is characterized by the rupture of a small conjunctival or episcleral blood vessel, leading to localized extravasation of blood beneath the conjunctiva.1, 2 Non-traumatic cases occur without external mechanical injury.1, 2 Clinically, it manifests as a sharply demarcated bright or dark red patch on the sclera, often prompting concern due to its striking appearance.1 Despite its alarming presentation, SCH is generally a benign condition that neither causes pain nor affects visual acuity, although some patients may report mild ocular discomfort or a foreign-body sensation.1 SCH typically resolves spontaneously within 1 to 2 weeks, analogous to the resolution of a cutaneous bruise, as the extravasated blood is gradually resorbed.3 While most cases are isolated and self-limiting, recurrent SCH or episodes accompanied by other ocular or systemic symptoms warrant further evaluation to exclude underlying systemic disorders.4, 5 Identifying risk factors for SCH is clinically important, as it may facilitate the early diagnosis and management of systemic conditions, thereby reducing the likelihood of recurrence. The most common precipitating factor is minor ocular trauma, such as vigorous eye rubbing.6 Other recognized triggers include acute increases in venous pressure associated with coughing, sneezing, or Valsalva maneuvers, as well as the use of anticoagulant or antiplatelet agents, including warfarin and aspirin.1, 6 Although vascular disorders such as hypertension and diabetes mellitus have been suggested as potential systemic risk factors, the literature addressing these associations remains limited.1, 7, 8 Thus, this study aimed to identify potential risk factors associated with SCH. Initially, a retrospective analysis was conducted to explore candidate risk factors, followed by a prospective study to validate the findings.

详细描述

a prospective study was performed at Hallym University Kangnam Sacred Heart Hospital, Hallym University Dongtan Sacred Heart Hospital and Hallym University Sacred Heart Hospital from Dec. 2022 to Dec. 2024. Patient assessments included the same systemic variables: sex, diabetes mellitus, hypertension, anticoagulant use (including both antiplatelet agents and novel oral anticoagulants [NOACs]), circulatory agents, and omega-3 supplementation. Circulatory agents included Ginkgo biloba extract formulations such as Gingkomin Tab and Ginexin-F, as well as magnesium, calcium supplements, and vasodilators such as trimetazidine and limaprost.12, 13 Patients were also asked to complete structured questionnaires addressing eye rubbing, sleep deprivation, fatigue, and increased intra-abdominal pressure due to physical factors such as heavy lifting, constipation, coughing, and prone positioning. Ophthalmologic examinations were performed using fundus photography to detect retinal hemorrhages and slit-lamp microscopy to assess the anterior segment. Assessment of ocular surface status was performed by measuring tear film break-up time (TBUT), corneal fluorescein staining (FSS), and grading conjunctivochalasis (CCH).14 TBUT was quantified in seconds based on the interval between the last blink and the first appearance of a dry spot, while FSS was graded using the Oxford grading scale.14 CCH was classified using a modified grading scale based on the number and extent of conjunctival folds. Grade 0 denoted the absence of folds; Grade 1 indicated a single fold; Grade 2 represented multiple folds that did not reach the tear meniscus; and Grade 3 included prominent folds encroaching upon and disrupting the tear meniscus.15

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
19 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • The patients aged 19 years or older who visited the ophthalmology outpatient clinic due to non-traumatic subconjunctival hemorrhage and the normal patients who visited the ophthalmology outpatient clinic for an ophthalmological examination were enrolled.

排除标准

  • Trauma patients are excluded.

结局指标

主要结局

Subconjunctival hemorrhage

时间窗: From December 2022 to December 2024

Detection and extent of Subconjunctival hemorrhage

次要结局

未报告次要终点

研究者

发起方
Hallym University Kangnam Sacred Heart Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Young Joo Shin

Professor

Hallym University Kangnam Sacred Heart Hospital

研究点 (1)

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