Repeatability and Agreement of Visante and Cirrus Anterior Segment Optical Coherence Tomography and Functional Infrared Thermography
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- equipment repeatability
研究概览
简要总结
Dry eye is a common condition that affects vision and quality of life in patients. Dry eye clinical research is limited to follow up of disease progression. Currently, most research outcomes are based on subjective patient complaints rather than objective assessment of the condition. Only few objective measurements for dry eye are available today and this is mainly the result of poor repeatability and inaccuracy.
This current study aims to evaluate 2 new non-invasive imaging techniques suitable for dry eye assessment.
Anterior segment optical coherence tomography (AS-OCT) is an imaging device that has the ability to image the tear meniscus of the eye in a safe and non-invasive manner. Image analysis can then indirectly determine the tear film volume. Improvements in the image resolution of these devices require a study that compares the repeatability and agreement of an older (Visante AS-OCT) and a newer instrument (Cirrus AS-OCT) which the current study aims to address.
Another method of evaluating dry eye disease is a novel technique that uses functional infrared thermography to measure tear evaporation rate. This study will also establish repeatability of measurements of the ocular surface temperature which are used to calculate tear evaporation rates.
Should these methods are found to be repeatable, they can be used in future clinical trials as an additional tool to investigate dry eye treatments.
详细描述
Study Objectives and Purpose:
Part A - AS-OCT repeatability and agreement
- The primary purpose of Part A is to compare the repeatability of the Cirrus with the Visante AS-OCT imaging system.
- The second objective is to identify the level of agreement in the tear meniscus measurements taken by the Cirrus and Visante AS-OCT.
Part B - Tear evaporimetry with functional infra-red thermography
- To evaluate the repeatability of Infrared thermography for ocular surface temperature measurements that are used for calculation of tear evaporation rates. If this is found to be acceptable, it will be correlated to tear meniscus parameters.
- To determine whether this method is able to detect temperature changes of the ocular surface.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Screening
- 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
- •Volunteers that are medically fit and willing to participate in this study.
排除标准
- •No eye surgery done within the previous 3 months
- •Active ocular infection or pterygium that may affect tear film stability.
- •Any other specified reason as determined by clinical investigator.
研究组 & 干预措施
Visante AS-OCT and Cirrus AS-OCT
The tear meniscus is the thin concave strip of the tear film near the eyelid margins. During the acquisition the participants place their chins on a chin rest and look at a fixation light/target. This whole procedure should not take more than 5 minutes. The patients are allowed to blink freely except for during the acquisition time of less than 5 seconds. The procedure will be repeated for the upper and lower tear meniscus of both eyes.
Thermography measurement
In total, four pairs of thermographic sequences on the ocluar surface temperature from volunteers will be taken.
- A thermographic sequence will be captured from each eye.
- After 20 minutes, a second pair of thermographic sequences will be captured.
- An eye mask with a temperature of not more than 40 deg C (will be worn by the volunteer for 5 minutes and a third pair of thermographic sequences will be captured immediately after mask removal.
- A fourth pair of thermographic sequences will be captured 1 hour after mask removal.
干预措施: EyeGiene (Device)
结局指标
主要结局
equipment repeatability
时间窗: 1 day
Part A - The repeatabilty coefficients of tear meniscus measurements derived from Visante and Cirrus AS-OCT and the agreement between tear meniscus measurements. Part B - Infrared thermography is expected to be repeatable in capturing OST measurements which will consequently result in repeatable tear evaporation rates. Temperature changes of the ocular surface will be adequately captured.
次要结局
- temperature changes(1 day)
研究者
Louis Tong
Clinician-Scientist, Consultant
Singapore National Eye Centre