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临床试验/NCT05241626
NCT05241626Unknown不适用

Anterior Segment Optical Coherence Tomography Study of the Tear Film and Cornea in Thyroid Eye Diseases.

Minia University2 个研究点 分布在 1 个国家目标入组 70 人开始时间: 2021年5月11日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
70
试验地点
2
主要终点
Tear Meniscus Depth (TMD):

研究概览

简要总结

use the anterior segment optical coherence tomography (AS-OCT) to evaluate the tear meniscus parameters, total corneal thickness (CT), and epithelial thickness in active and inactive thyroid eye diseases (TED) patients and compare them with age-matched controls.

详细描述

A prospective case-control clinical study. The study subjects were divided into 3 groups, group 1 of inactive thyroid patients, group 2 of active thyroid patients, and group 3 of healthy controls. The AS-OCT was used to measure lower tear meniscus parameters (tear meniscus height (TMH), tear meniscus depth (TMD), and tear meniscus area (TMA)), total CT and epithelial thickness

研究设计

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

入排标准

性别
All
接受健康志愿者

入选标准

  • The inclusion criteria were patients with thyroid disorders with age between 20 to 60 years with no ocular manifestations

排除标准

  • being younger than 20 or older than 60, presence of systemic diseases as diabetes mellitus (DM) and autoimmune diseases as rheumatoid arthritis (RA) that may cause dry eye, previous ocular surgery, use of contact lenses, smokers, pregnant women, and breastfeeding women.

结局指标

主要结局

Tear Meniscus Depth (TMD):

时间窗: through study completion, an average of 6 months

represented as the distance between the center of the upper boundary of the tear meniscus and the point at the bottom boundary where the cornea meets the eyelid

Tear Meniscus Height

时间窗: through study completion, an average of 6 months

represented by a line joining the points corresponding to the upper corneo-meniscus junction to the lower eyelid-meniscus junction

Tear Meniscus Area (TMA)

时间窗: through study completion, an average of 6 months

triangular area formed by the corneal anterior boundary, anterior boundary of the lower eyelid and anterior borderline of the tear meniscus

次要结局

未报告次要终点

研究者

发起方
Minia University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Mohamed Salah

Dr Mohamed Salah

Minia University

研究点 (2)

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