Controlled Adverse Environment: A Pilot Study to Evaluate Tear Film Stability and Tear Evaporation
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 10
- 试验地点
- 2
- 主要终点
- Tear Evaporation Rate
研究概览
简要总结
Dry eye and ocular surface disease account for a lot of morbidity and socio-economic burden in Asia and the rest of the world. This is a small pilot study to evaluate tear function under different conditions of humidity and temperature. This data will be useful for designing future trials in ocular surface and dry eye. The data will likely be used to propose a larger national funded project involving clinical trials. This study involves collaboration between engineers, ocular surface clinicians as well as specialists from the defence science organisation. When successfully completed, the project will increase the capability of Singapore Eye Research Institute and Singapore National Eye Centre to support future industry and academic research in the ocular surface.
详细描述
Study Objectives and Purpose:
- A primary purpose of the study is to evaluate fluorescein tear break up times in participants under different humidity/ temperature conditions.
- The second aim is to assess the tear evaporation rates in a dynamic fashion over 20 seconds (based on a non-invasive ocular thermography method) after exposure to different humidity/temperature conditions.
Study Design: Prospective, non-comparative, clinical study
Rationale:
The ocular surface research team who is based at the dry eye service of the Singapore National Eye Center is experienced in the assessment of the ocular surface in patients and clinical trial participants. Collaborators from the DSO National laboratory already have experience in conducting human studies in a controlled environment in Singapore that has been proven to be safe and has passed necessary regulatory approval. In addition, recent technological advances have allowed collaborators from NTU and Singapore Polytechnic to perform non-invasive tear evaporimetry in a dynamic way between blinks. Together, this is a strong research team that can address the important question of the influence of temperature and humidity on the tear film stability.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 21 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •must have undergone screening examination
排除标准
- •unable to go to the DSO laboratory or undergo any of the study procedures
结局指标
主要结局
Tear Evaporation Rate
时间窗: 20 minutes after the required temperature and humidity in the chamber is achieved
The rate of tear evaporation is measured by the use of ocular thermography. For each subject,his/her ocular surface temperature will be recorded twice, one for each eye. The subject at first rests his/her chin on a chin rest, with his/her forehead lean against a metal frame (which is part of the chin rest). Then the recording starts lasting approximately 20seconds for each eye. While recording, the subject needs to look straight into the lens, but can blink naturally. After this, the recording data will be analyzed to derive the evaporation rate using a mathematical model.
次要结局
- Tear Film Break up Time(20 minutes after the required temperature and humidity in the chamber is achieved)
研究者
Andrea Petznick, PhD
Postdoctoral Research Fellow
Singapore Eye Research Institute