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临床试验/NCT07028736
NCT07028736已完成不适用

Assessment of Dry Eye Disease and Retinal Nerve Fiber Layer Thickness in Chronic Smokers

Cairo University1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2023年5月2日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
50
试验地点
1
主要终点
Non-invasive tear film breakup time

研究概览

简要总结

This study aimed to examine the impact of long-term smoking on dry eye parameters and retinal nerve fiber layer thickness in individuals who are chronic smokers.

详细描述

Dry eye disease (DED) is a multifaceted disorder of the ocular surface characterized by instability of the tear film, which subsequently leads to symptoms such as ocular discomfort, visual disturbances, and potential damage to the surface of the eye.

Cigarette smoking has been recognized as a possible contributing factor to the development of DED, with various reports suggesting that it may alter tear film composition and stability, leading to ocular surface damage.

Chronic smoking can lead to oxidative stress, vascular dysfunction, and inflammation, which may contribute to retinal nerve fiber layer (RNFL) thinning and optic nerve damage.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Other

入排标准

年龄范围
30 Years 至 60 Years(Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Age from 30 to 60 years.
  • •Both sexes.
  • •Chronic smokers.

排除标准

  • •History of ocular surface diseases affecting tear production or secretion (such as Sjogren's syndrome or Stevens-Johnson disease).
  • •Conjunctivitis.
  • •Blepharitis.
  • •Chronic contact lens use or gross lid abnormalities.
  • •Preexisting glaucoma.
  • •Retinal diseases.
  • •Optic nerve pathology.
  • •Ocular trauma.
  • •Chemical burns.
  • •Recent eye surgery (within three months).
  • •Trachoma-related complications

结局指标

主要结局

Non-invasive tear film breakup time

时间窗: During examination (Baseline)

Non-invasive tear film breakup time (NIBUT) was automatically analyzed using artificial intelligence, with results classified as Grade 0 (normal, first rupture time \>10s), Grade 1 (warning, 6- 9s), or Grade 2 (dry eye, ≤5s)

次要结局

  • Tear meniscus height(During examination (Baseline))
  • Lipid layer thickness(During examination (Baseline))
  • Ocular Surface Disease Index (OSDI) score(During examination (Baseline))
  • Retinal nerve fiber layer thickness(During examination (Baseline))
  • Correlations between dry eye parameters and Ocular Surface Disease Index (OSDI) score(During examination (Baseline))
  • Correlations between dry eye parameters and retinal nerve fiber layer (RNFL) thickness in both groups(During examination (Baseline))

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Merna Tharwat Wanees Nakhla

Resident of Ophthalmology, Faculty of Medicine, Cairo University, Cairo, Egypt.

Cairo University

研究点 (1)

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