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临床试验/CTRI/2022/06/043553
CTRI/2022/06/043553尚未招募不适用

Evaluation of dry eye disease(DED) in systemic lupus erythematosus(SLE)and rheumatoid arthritis (RA) and its association with anti SS-A and SS-B autoantibodies at a tertiary care centre in Puducherry.

JIPMER1 个研究点 分布在 1 个国家目标入组 145 人开始时间: 2022年1月7日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
JIPMER
入组人数
145
试验地点
1
主要终点
Presence of Dry Eye Disease in SLE and RA patients

研究概览

简要总结

Dry eye is a multifactorial disease of the ocular surface characterized by loss of homeostasis of the tear film; and accompanied by ocular symptoms, in which tear film instability and hyperosmolarity, ocular surface inflammation and damage, and neurosensory abnormalities play etiological roles. The ocular surface environment is maintained by immune regulation which fights exogenous and endogenous pathogens while maintaining tolerance to self-antigens and commensals. In autoimmune diseases like SLE and RA, immune regulation gets disturbed by multiple triggers which may be environmental, microbial or genetic culminating in aberrant activation of the immune system. Dry eye disease (DED) in SLE and RA occurs due to immune dysregulation leading to self-reactive immune cells producing abnormally elevated levels of pro-inflammatory cytokines which impair secretory function, increase corneal permeability, apoptosis of surface epithelial cells, and in severe cases, loss of goblet cells or due to secondary Sjogren’s syndrome is caused by CD4+ T cell infiltration of lacrimal glands. In SLE and RA patients, the prevalence of DED is reported as 16 % and 25-65%, respectively, previously.  None of them reports on patients from India. Antibodies to Ro(SS-A) and La(SS-B) occur in a subset of patients constituting 50% and 20% in SLE, and 29% and 7% in RA, respectively. They are more prevalent in primary Sjogren’s syndrome(SS). Patients with SLE and RA having overlap syndrome with SS possess both antibodies. It may be useful to assess if SLE and RA patients with DED have a higher prevalence of these antibodies.

Primary objective: To find the prevalence of dry eye disease in systemic lupus erythematosus and rheumatoid arthritis patients.

Secondary objective:  To identify the association with dry eye disease anti-SS-A and SS-B autoantibodies in systemic lupus erythematosus and rheumatoid arthritis.

The following evaluation will be done for all patients. 1. Ocular symptom score, 2. Tear film breakup time (TBUT), 3. Ocular Surface Staining Score (NEI), 4. Schirmer’s test, 5. Serum SS-A and SS-B autoantibody levels.

The final outcome is 1. Presence of DED in SLE and RA patients, 2. Presence of anti-SS-A and SS-B autoantibodies

研究设计

研究类型
Observational

入排标准

年龄范围
18.00 Year(s) 至 99.00 Year(s)(—)
性别
All

入选标准

  • Inclusion criteria: Patients with SLE fulfilling the ACR/SLICC 2012 criteria and RA fulfilling ACR/EULAR 2010 criteria, aged >18 years.

排除标准

  • Exclusion criteria: Patients with active keratitis, exposure keratitis, conjunctivitis, Steven-Johnson syndrome, ocular cicatricial pemphigoid, lacrimal gland malignancies, sarcoidosis.

结局指标

主要结局

Presence of Dry Eye Disease in SLE and RA patients

时间窗: Evaluation done at baseline

次要结局

  • Presence of anti-SS-A and SS-B autoantibodies in serum of patients with clinical dry eye in RA and SLE(Blood sample taken at the time of recruitment)

研究者

发起方
JIPMER
申办方类型
Research institution and hospital

研究点 (1)

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