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临床试验/NCT02712762
NCT02712762已完成不适用

Dry Eye and Ocular Surface Disease in Chronic Graft-Versus-Host Disease (GVHD) Patients

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

研究概览

简要总结

This study aims to profile the ocular surface inflammation of chronic Graft-Versus-Host Disease patients by investigating conjunctival cells, and clinical imaging for conjunctival redness and tear stability. Hence, the investigators expect to find an increased in inflammatory cell population in GVHD conjunctival samples.

详细描述

Dry eye is a multi-factorial disease that is frequently encountered in ophthalmological practice. Common dry eye symptoms include eye irritation, heaviness of the eyelids, blurred vision and light sensitivity (1). The worldwide prevalence of dry eye is generally high (2-4). In Asia, dry eye may affect up to 22% of adults above 40 years in China (5) and Japan (3). In Asian patients older than 65 years, prevalence rates of dry eye can be as high as 80% if diagnosis is based on abnormal tear stability, or as high as 60% on meibomian gland dysfunction (MGD), a major cause of tear instability (6).

Most dry eye patients can be successfully managed with lubricants, punctal occlusion, steroid and/or cyclosporine eye drops. However, some patients with severe dry eye and likely underlying diseases for example Graft-Versus-Host Disease (GVHD), who have exhausted conventional treatments may amount to 10-20 cases a year and are difficult to manage. These patients and their physicians are helpless when faced with these scenarios.

Hematopoietic stem cell transplantation (SCT) has been established as a potential curative therapy for hematologic malignancies (9). The number of SCT recipients has increased exponentially worldwide over the past 2 decades. GVHD is the major cause of morbidity and mortality in patients undergoing allogeneic SCT (10).

Dry eye associated with chronic GVHD is one of the major late complications after allogeneic SCT; it has a significant impact on patients' quality of life (11-13) and can lead to blindness (14). The immunological process of dry eye associated with chronic GVHD remains largely unknown but is believed to be traditional alloreactivity to recipient tissues.

The investigators propose to collaborate with Singapore General Hospital, Department of Haematology to focus on the clinical characteristics and immunological profile of the ocular surface inflammation in more severe chronic GVHD patients. Dry eye severity is more severe in chronic GVHD patients at SNEC, compared to idiopathic cases of dry eye. This may be due to referral bias, or may be related to the systemic disease. As such, the investigators intend to do a pilot study to define some ocular characteristics of non-referred haematology patients with GVHD. The investigators propose to screen and recruit 30 suitable participants who have chronic GVHD. Tests to be performed will include ocular imaging (Oculus K5M), ocular immunological profile (conjunctiva immune cells) and ocular surface inflammation (MMP-9 tear marker).

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

  • Clinically diagnosed with chronic Graft Versus Host Disease (GVHD).

排除标准

  • 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: Baseline

次要结局

  • Measuring tear biomarker(Baseline)
  • Corneal Fluorescein Staining Score(Baseline)
  • Imaging of Conjunctival Redness(Baseline)
  • Non-invasive Tear Break-up Time (NIKBUT)(Baseline)
  • Conjunctival Immune Cell Profile(Baseline)
  • Tear production with Schirmers I test(Baseline)

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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