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临床试验/NCT02217137
NCT02217137已完成不适用

Analysing Tear Protein, Conjunctival Cells, and Imaging Eyes in Patients With Rheumatoid Arthritis and Systemic Lupus Erythematosus

Singapore National Eye Centre1 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2014年6月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
80
试验地点
1
主要终点
Profile tear cytokines

研究概览

简要总结

Rheumatoid Arthritis (RA) and Systemic Lupus Erythematosus (SLE) are chronic systemic autoimmune diseases that have been reported to affect the ocular surface of patients [1,2]. However, the nature of the disturbances of the ocular surface immunity and their relationship to systemic disease severity are poorly understood.

This study aims to profile the ocular surface inflammation of RA and SLE patients by a., analysing levels of tear cytokine, and b., investigating conjunctival cells, and c. clinical imaging for conjunctival redness and tear stability.

20 consecutive RA patients and 20 consecutive SLE patients will be recruited from the Singapore General Hospital Rheumatology clinic. 20 age matched controls for SLE and another 20 age matched controls for RA will be recruited.

All participants will undergo

  1. Tear collection with Schirmer strips
  2. EyePRIMTM (Opia Technologies) Impression Cytology Device for conjunctival sampling
  3. Clinical ocular surface assessment with Oculus Keratograph 5M
  4. Collection of blood via venipuncture (optional)
  5. Retrieval of Clinical Information of participants

The association of cytokines in the tears with various cellular and immune markers, as well as clinical signs of inflammation and tear stability will be investigated. This will be useful for further longitudinal studies of treatment in autoimmmune disease patients.

详细描述

Background and Rationale

Inflammatory autoimmune disease and eye involvement Rheumatoid Arthritis (RA) and Systemic Lupus Erythematosus (SLE) are chronic systemic autoimmune diseases of unknown etiology [2]. Ocular manifestations may range from conditions which cause distressing symptoms of discomfort, such as dry eye syndrome, to potentially sight-threatening conditions such as retinal vasculitis. The ocular surface is agreed to be the site most commonly affected by systemic autoimmune diseases, manifesting as dry eye syndrome. However, its related complications are poorly addressed [1,2]. The severity of ocular surface inflammation may be related to systemic immunology since systemic treatment will alter the signs of ocular surface disease.

EyePRIMTM (Opia Technologies) Impression Cytology Device Studies have shown that this method of combining flow cytometry with OSIC is useful to phenotype recovered cells from the superficial layers of the ocular surface [3]. There has been recent advances in clinical techniques for obtaining conjunctival cells for reseach studies. An example of an award winning device is the EyePRIMTM (Opia Technologies).

Previous studies have shown that EyePRIMTM is able to obtain sufficient cells for flow cytometry for immune markers [4]. In the study, the ocular surface of three healthy patients were analysed using EyePRIMTM and conventional semi-circular Supor PES filters for flow cytometry. One EyePRIMTM was used to impression the lateral bulbar conjunctiva and a second, the medial bulbar conjunctiva of the same eye. Cells were recovered from both EyePRIMTM using gentle agitation with a pipette tip for one minute, and then stained with antibody markers for leukocytes (CD45), CD16, epCAM, HLA-DR and a dead cell exclusion dye. Results have shown that the mean corrected total cell count collected using EyePRIMTM was greater than conventional methods (475,544 cells vs 335,226 cells). Out of the total cells collected, the mean corrected number of lymphocytes found via staining with CD45 antibody was around 1000.

Advances in clinical phenotyping Dry eye is a common ocular surface disease mediated by inflammation. It is postulated that dry eye in the context of systemic autoimmune diseases is caused by the infiltration of activated T lymphocytes into the bulbar conjunctiva, beginning a vicious cycle of chronic inflammation of the ocular surface [5]. In the dry eye database at SNEC/SERI (unpublished data), we found higher levels of fluorescein corneal staining, indicating presence of punctate epithelial erosions in patients with RA compared to dry eye patients without systemic autoimmune diseases. While we have not personally conducted studies on SLE patients, it is documented in existing literature that significant signs of dry eye have been detected in SLE patients using older assessment modalities such as the Schirmer's test and Rose Bengal staining [6].

研究设计

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

入排标准

年龄范围
21 Years 至 99 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Clinically diagnosed with Rheumatoid Arthritis or Systemic Lupus Erythematosus

排除标准

  • Known history of thyroid disorders (diagnosed by physician).
  • No ocular surgery within the last 3 months and LASIK within 1 year.
  • Ocular surface diseases such as pterygium, or obvious lid/orbital disease with lagophthalmos.
  • Any other specified reason as determined by clinical investigator.

结局指标

主要结局

Profile tear cytokines

时间窗: 1 day

the inflammatory cytokines concentration

次要结局

  • Profile immune response(1 day)

研究者

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

Louis Tong

Clinician-Scientist, Senior Consultant

Singapore National Eye Centre

研究点 (1)

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