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临床试验/NCT05015465
NCT05015465Unknown不适用

Anterior Segment Optical Coherence Tomography of Cornea in Patients With Child Onset Systemic Lupus

Minia University1 个研究点 分布在 1 个国家目标入组 140 人开始时间: 2020年7月1日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
140
试验地点
1
主要终点
Measurement of Tear meniscus.

研究概览

简要总结

The aim of thie study to assess tear film parameters such as tear meniscus height (TMH), tear meniscus area (TMA), and tear meniscus depth (TMD). In addition, corneal pachymetry and epithelial thickness maps in juvenile SLE patients and compared to healthy subjects of similar age and gender.

详细描述

Juvenile systemic lupus erythematous (SLE) is a relapsing and remitting autoimmune connective tissue disorder that can affect many organs such as skin, joints, kidneys, eye, and brain (1) . SLE has a global prevalence of 0.3 to 23.2 cases per 100,000. Women are more likely than men to develop the disease. Four out of the following 11 diagnostic criteria are sufficient for the diagnosis of SLE, malar rash, discoid rash, oral ulcers, non-erosive arthritis, serositis, photosensitivity, renal disorder, neurological disorder, hematological disorder, immunological disorder, and presence of antinuclear antibodies. (2,3)

Ocular manifestations occur in about one third of juvenile SLE patients with keratoconjunctivitis sicca being the most common manifestation which is characterized by decreased tear film aqueous layer. Scleritis, retinal vasculitis (which is often associated with CNS lupus), and papillitis are considered as the most serious ocular manifestations. (4)

Corneal involvement in juvenile SLE affects the superficial epithelium, resulting in superficial punctate keratitis, which is believed to be caused by Sjögren's syndrome (SS). However, some cases of non-infiltrative and infiltrative peripheral ulcerative keratitis have been identified (5) .

Schirmer's test and fluorescein breakup time test (FBUT) are two common clinical tests used to analyze tear film. (6,7) Using an in vivo, non- contact technique, anterior segment optical coherence tomography (AS- OCT) is now used to image the tear film, measure the lower tear film height and area, measure corneal thickness (pachymetry), and measure surface epithelial thickness. (8,9)

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
10 Years 至 18 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • Age ≤18 years old. Patients with juvenile SLE diagnosed by a rheumatologist with no ocular involvement upon clinical examination

排除标准

  • 1- Patients with history of intraocular surgery as cataract surgery ,retinal detachment surgery, anti-glucoma surgery.
  • Patients with history of any corneal refractive surgery as LASIK, PRK.
  • Patients with significant media opacity as corneal opacity, cataract.
  • Patients with ocular diseases as glaucoma, uveitis.
  • Patients with any retinal affection as pathological myopia, macular hole, age related macular degeneration and retinal vascular occlusion.
  • Patients with systemic diseases as diabetes mellitus, hypertension, abnormal kidney function.

结局指标

主要结局

Measurement of Tear meniscus.

时间窗: 3 months

to measure lower tear meniscus height and area and depth with AS-OCT and comparing results between 2 groups; juvenile SLE patients and normal subjects.

Measurement of corneal structural changes

时间窗: 3 months

To measure corneal Thickness, epithelial thickness and stromal thickness using AS-OCT comparing results between 2 groups; juvenile SLE patients and normal subjects.

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

Principal Investigator

Minia University

研究点 (1)

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