The Assessment of Tear Layer and Tear Layer Lipid Distribution Pre and 1 Month Post Pterygium Surgery Using a LipiView Ocular Surface Interferometer (LipiView)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 76
- 试验地点
- 1
- 主要终点
- tear lipid layer thickness
研究概览
简要总结
The investigators study aims to capture the objective effects of pterygium surgery on tear layer lipid thickness and the tear layer.
Previous objective studies of the tear film has been limited to corneal staining grading, tear break up time and Schirmer's test which have been shown to poor to moderate repeatability. The effect of pterygiums on tear layer lipid thickness (LLT) has not previously been explored. With the LipiView Ocular Surface Interferometer, the investigators have the ability to assess the optical coherence interference pattern produced by light reflected off the tear film in a safe and non-invasive manner. Software analysis of the image then measures the tear LLT which can be used to objectively quantify the diagnosis of lipid-deficient dry eye.
详细描述
Pterygium is a condition characterized by abnormal conjunctival growth on the cornea and is particularly prevalent in tropical climates. In severe circumstances, it may lead to visual loss by obscuration of the visual axis and inducing corneal astigmatism (1). It is often also associated with dry eye symptoms and studies have previously shown some correlation with shortened tear break up time (TBUT)(2) but not Schirmer's Test (3).
Schirmer's Test, corneal staining and TBUT are often used to investigate symptoms of dry eyes but the diagnosis and assessment is often difficult due to the poor repeatability of the tests(4). Treatments for dry eyes often rely on patient's subjective symptomatic improvements as a measure of outcome although no literature has been published of subjective symptoms for pterygium patients. The effects of pterygium surgery and tear lipid layer thickness has also not been studied.
The LipiView Ocular Surface Interferometer is a HSA-approved imaging device that allows clinicians evaluate the characteristics and thickness of the tear lipid layer thickness (LLT) in a safe and non-invasive manner. The device utilizes white light from a LED source that is directed at the tear film over the inferior corneal region. Reflected light is captured by a high resolution camera and the optical inference pattern is evaluated by software to determine the LLT (5). It also was found to correlate with other dry eye diagnostic tests, such as tear film break-up time (TBUT), Schirmer's test and corneal staining(6,7). LLT is also reported to better correlate with symptoms than other objective dry eye tests(5).
LipiView was also capable of detecting a significant change in longitudinal lipid thickness in 10 patients one month after blepharoplasty. A similar result may be obtained from the investigators patients post pterygium surgery.
This current study aims to investigate the effects of pterygium surgery on tear lipid layer thickness with LipiView. The results will be compared with the effects of pterygium surgery on TBUT, and corneal staining. The subjective improvement in dry eye symptoms post pterygium surgery will also be studied.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
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
- 是
入选标准
- •Normal controls or patients with pterygium who have consented for pterygium surgery and are willing to participate in this study
排除标准
- •Active ocular surface conditions such as infections.
- •Any other specified reason as determined by clinical investigator.
结局指标
主要结局
tear lipid layer thickness
时间窗: 1 month
An increase in tear lipid layer thickness 1 month post pterygium surgery in the operated eye
次要结局
未报告次要终点
研究者
Louis Tong
Clinician-Scientist, Senior Consultant
Singapore National Eye Centre