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Ocular Surface Changes and Meibomian Gland Dysfunction in Rheumatologic Patients

2026年9月3日 更新者：Abanoub Saber Bakheet Gabra、Assiut University

Ocular Surface Changes and Meibomian Gland Dysfunction in Rheumatologic Patients: A Cross-Sectional Analytical Study

This observational study aims to assess the frequency and severity of Meibomian Gland Dysfunction (MGD) and associated ocular surface changes in patients with systemic autoimmune rheumatic diseases compared with healthy volunteers.

Meibomian glands are specialized glands in the eyelids that produce the lipid layer of tears, preventing tear evaporation. Systemic inflammation in rheumatologic conditions may affect these glands, leading to dry eye symptoms and ocular surface damage.

A total of 150 participants (120 rheumatologic patients and 30 healthy controls) will be evaluated in a single cross-sectional examination. Rheumatologic diagnoses include Rheumatoid Arthritis, Systemic Lupus Erythematosus, Sjogren's Syndrome, Ankylosing Spondylitis, and Psoriatic Arthritis.

Participants will undergo a standardized series of non-invasive and minimally invasive eye examinations, including:

  • An ocular symptom questionnaire (Ocular Surface Disease Index)
  • Non-contact infrared meibography to assess meibomian gland loss (Meiboscore)
  • Non-invasive tear break-up time (NIBUT) and tear meniscus height measurements
  • Slit-lamp biomicroscopy and corneal fluorescein staining

The study also examines how meibomian gland alterations correlate with systemic disease activity scores and inflammatory blood markers.

研究概览

地位

尚未招聘

条件

研究类型

观察性的

注册 (估计的)

150

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

  • 成人
  • 年长者

接受健康志愿者

不适用

取样方法

非概率样本

研究人群

Adult patients attending outpatient rheumatology services at Assiut University and Al-Azhar University with confirmed diagnoses of systemic autoimmune rheumatic diseases (Rheumatoid Arthritis, Systemic Lupus Erythematosus, Sjogren's Syndrome, Ankylosing Spondylitis, or Psoriatic Arthritis), alongside age- and sex-matched healthy control volunteers from the same geographic region with no systemic autoimmune disease or active ocular surface complaints.

描述

Inclusion Criteria:

  • Age 18 years or older
  • Ability to provide written informed consent
  • For rheumatologic patients: Confirmed clinical diagnosis of one of the following autoimmune diseases:
  • Rheumatoid Arthritis (2010 ACR/EULAR classification criteria)
  • Systemic Lupus Erythematosus (2019 EULAR/ACR classification criteria)
  • Sjogren's Syndrome (2016 ACR/EULAR classification criteria)
  • Ankylosing Spondylitis (modified New York criteria)
  • Psoriatic Arthritis (CASPAR criteria)
  • For healthy controls: Age- and sex-matched individuals with no systemic autoimmune disease and no current ocular surface complaints

Exclusion Criteria:

  • Chronic use of topical antiglaucoma eye drops
  • Ocular surgery within the past 6 months
  • Active ocular infection or active uveitis
  • Contact lens wearers who have not discontinued wear for at least 2 weeks
  • History of ocular chemical burns
  • Pregnancy or lactation
  • Incomplete rheumatologic records or missing essential laboratory data

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

队列和干预

团体/队列
Rheumatologic Patients
Adult patients (aged 18 years or older) with an established diagnosis of one of five systemic autoimmune rheumatic diseases: Rheumatoid Arthritis (2010 ACR/EULAR criteria), Systemic Lupus Erythematosus (2019 EULAR/ACR criteria), Primary Sjogren's Syndrome (2016 ACR/EULAR criteria), Ankylosing Spondylitis (modified New York criteria), or Psoriatic Arthritis (CASPAR criteria) (n = 120). Participants undergo non-invasive meibography, non-invasive tear break-up time (NIBUT), tear meniscus height (TMH), slit-lamp examination, corneal fluorescein staining, and the Ocular Surface Disease Index (OSDI) questionnaire.
Healthy Controls
Age- and sex-matched healthy control subjects (aged 18 years or older) with no history of systemic autoimmune diseases and no active ocular surface complaints (n = 30). Participants undergo the same standardized ophthalmic assessment battery, including non-invasive meibography, non-invasive tear break-up time (NIBUT), tear meniscus height (TMH), slit-lamp examination, corneal fluorescein staining, and the Ocular Surface Disease Index (OSDI) questionnaire.

研究衡量的是什么？

主要结果指标

结果测量
措施说明
大体时间
Meibomian Gland Loss Assessed by Meiboscore
大体时间：Baseline
Meibomian gland drop-out is evaluated using non-contact infrared meibography and graded according to the Meiboscore scale for each eyelid (upper and lower): Grade 0 (no loss of meibomian glands), Grade 1 (gland loss involving less than one-third of the total area), Grade 2 (gland loss involving between one-third and two-thirds of the total area), and Grade 3 (gland loss involving more than two-thirds of the total area). Scores for the upper and lower eyelids are summed to yield a total Meiboscore per eye ranging from 0 to 6, where higher scores indicate greater meibomian gland loss and atrophy.
Baseline

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

Assiut University

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (估计的)

2026年10月1日

初级完成 (估计的)

2027年10月1日

研究完成 (估计的)

2027年11月1日

研究注册日期

首次提交

2026年9月3日

首先提交符合 QC 标准的

2026年9月3日

首次发布 (实际的)

2026年9月9日

研究记录更新

最后更新发布 (实际的)

2026年9月9日

上次提交的符合 QC 标准的更新

2026年9月3日

最后验证

2026年9月1日

更多信息

与本研究相关的术语

关键字

其他相关的 MeSH 术语

其他研究编号

  • MGD in Rheumatologic Patients

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