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临床试验/NCT02715323
NCT02715323已完成不适用

Exploring Immune Cell Signatures in Autoimmunity and Ocular Surface Stress

Singapore National Eye Centre1 个研究点 分布在 1 个国家目标入组 11 人开始时间: 2016年5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
11
试验地点
1
主要终点
Dry Eye Symptoms (SPEED Questionnaire)

研究概览

简要总结

Ocular surface disease, especially dry eye and scleritis, commonly affects patients with autoimmune diseases. Ocular surface immune cells are increased in autoimmune disease; however the full subset of immune cells activated is unknown. Recent experimental studies show that dendritic cells and T cells in the cornea are critically associated with corneal nerve innervation. Corneal confocal microscopy (CCM) allows rapid non-invasive in vivo imaging of dendritic cells and corneal nerves. The investigators propose to investigate how ocular surface health, conjunctival immune cells and corneal nerve/dendritic cell morphology interact in 3 rheumatological conditions: Sjogren's syndrome (SS), Rheumatoid arthritis (RA), Systemic lupus erythematosus (SLE).

The preliminary flow cytometric studies show that various immune cells (eg: T cells, B cells, and dendritic cells) can be quantified using minimally invasive impression membranes (Eyeprim). Clinically, the research team is experienced in measuring features of ocular surface inflammation (conjunctival redness, tear breakup times) with Oculus keratograph5M. The investigators also aim to harvest conjunctival immune cells using impression cytology and quantify specific cell types with flow cytometry. Corneal nerve morphology and dendritic cell density and distribution will be assessed using CCM; in collaboration with the group who have pioneered this technique.

The investigator anticipate that alterations in corneal nerve and dendritic cell parameters will correlate with immune activation/inflammation, deterioration of tear function and increased systemic severity of the rheumatological disease. In addition, the investigators hypothesize that the lower the corneal nerve density, the higher the number of corneal dendritic cells and conjunctival inflammatory cells. Studying these relationships may allow a better mechanistic understanding of local corneal and systemic immune activation and the development of a non-invasive ophthalmic surrogate marker of dendritic cell activation and nerve fibre loss to aid earlier diagnosis, risk stratification and the development of new therapies in autoimmune patients with severe dry eye.

详细描述

  1. BACKGROUND AND RATIONALE

1.1 General Introduction

Ocular surface disease, especially dry eye and scleritis, commonly affects patients with autoimmune diseases. Ocular surface immune cells are increased in autoimmune disease; however the full subset of immune cells activated is unknown. Recent experimental studies show that dendritic cells and T cells in the cornea are critically associated with corneal nerve innervation. Corneal confocal microscopy (CCM) allows rapid non-invasive in vivo imaging of dendritic cells and corneal nerves. The investigators propose to investigate how ocular surface health, conjunctival immune cells and corneal nerve/dendritic cell morphology interact in 3 rheumatological conditions: Sjogren's syndrome (SS), Rheumatoid arthritis (RA), Systemic lupus erythematosus (SLE).

The preliminary flow cytometric studies show that various immune cells (eg: T cells, B cells, and dendritic cells) can be quantified using minimally invasive impression membranes (Eyeprim). Clinically, the research team is experienced in measuring features of ocular surface inflammation (conjunctival redness, tear breakup times) with Oculus keratograph5M. The investigators also aim to harvest conjunctival immune cells using impression cytology and quantify specific cell types with flow cytometry. Corneal nerve morphology and dendritic cell density and distribution will be assessed using CCM; in collaboration with the group who have pioneered this technique.

Investigators anticipate that alterations in corneal nerve and dendritic cell parameters will correlate with immune activation/inflammation, deterioration of tear function and increased systemic severity of the rheumatological disease. In addition, the investigator hypothesize that the lower the corneal nerve density, the higher the number of corneal dendritic cells and conjunctival inflammatory cells. Studying these relationships may allow a better mechanistic understanding of local corneal and systemic immune activation and the development of a non-invasive ophthalmic surrogate marker of dendritic cell activation and nerve fibre loss to aid earlier diagnosis, risk stratification and the development of new therapies in our autoimmune patients with severe dry eye.

研究设计

研究类型
Observational
观察模型
Cohort
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

  • 未提供

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

Dry Eye Symptoms (SPEED Questionnaire)

时间窗: Day 0

次要结局

  • To profile immune cells with EyePRIM membrane(Day 0)
  • Measuring cornea nerve density(Day 0)
  • Non-invasive Tear Break-up Time (NIKBUT)(Day 0)
  • Conjunctival Redness Grading with Oculus Keratograph 5M(Day 0)
  • Tear collection from Schirmers strip(Day 0)
  • Documenting Corneal Fluorescein Staining(Day 0)

研究者

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

Louis Tong

Principal Investigator

Singapore National Eye Centre

研究点 (1)

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