Inter and Intra Examiner Reproducibility of Anterior Segment Optical Coherence Tomography (AS-OCT) for Imaging Conjunctivochalasis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- The repeatabilty of objective conjunctivochalasis measurements of HD-Cirrus AS-OCT from the same examiner, and between the two examiners
研究概览
简要总结
Conjunctivochalasis refers to loose redundant, non-edematous inferior conjunctiva that is situated between the globe and lower eyelid, and usually it occurs bilaterally. It has been reported to cause ocular discomfort, tear instability, alteration of tear spreading and subsequently dry eye, which is a common condition that affects vision and quality of life in patients. This condition has also been reported to be associated with aging and ocular surface inflammation.
The assessment of conjunctivochalasis was traditionally based on silt lamp examination and this may be cumbersome and highly subjective. Only recently, researchers have advocated the use of imaging and more objective documentation by anterior segment optical coherence tomography (AS-OCT), using Fourier-Domain RTVue-100 OCT. The AS-OCT is an imaging method that documents the tear meniscus and prolapse of conjunctiva into the tear meniscus in a safe, rapid and non-invasive way. Image analysis on the area of prolapsed conjunctiva can then be used to ascertain the severity of conjunctivochalasis. We propose the use of HD-Cirrus AS-OCT for the imaging of conjunctivochalasis, since this technique provides more magnified and colored digital images, which helps to delineate different tissues and serves as a better education tool for patients.
This current study aims to investigative the inter and intra examiner reproducibility of imaging conjunctivochalasis using HD-Cirrus AS-OCT, using patients from the dry eye clinic from the Singapore National Eye Centre. These patients will be asked to come to the centre for imaging and have three scans of the same eye performed in one session by two trained investigators consecutively. The resulting limits of repeatability will be very useful for us to follow up patients who undergo surgical or diathermy treatment for conjunctivochalasis, and for sample size calculation in the planning of interventional studies.
详细描述
This study will be conducted in compliance with the protocol, SGCP and the applicable regulatory requirements.
Dry eye is a condition that affects 5-35% of the population9. Common symptoms of this condition include eye irritation, heaviness of the eyelids, visual disturbances, tearing and light sensitivity9-11. This significantly impacts the quality of life and vision of dry eye patients. In addition, there is a significant socio-economic burden. In 2009, 54,051 patients sought treatment for dry eye in the Singapore National Eye Centre (SNEC). In total, the costs for dry eye medication amounted to $181,354.1712. Additionally, dry eye affects work productivity which further adds on to the socio-economic burden9,12.
Currently, the diagnosis and assessment of dry eye is hindered by tests that have poor repeatability, some of which cause discomfort due to their invasiveness. As a result most clinical studies involving dry eye treatment rely on symptomatic improvements as a primary outcome measure. However, symptomatic improvements are a poor measure in determining treatment effectiveness. This may be a result of disease progression that damages nerves which consequently desensitizes the eye. Also, it is not uncommon that patients feel a reduction of discomfort of the eye before objective improvements can be noted by the clinician. An assessment based on symptoms alone is therefore inappropriate11.
Over the last few years, SNEC/SERI has built up a dedicated team of dry eye researchers for trials and evaluation of diagnostic devices. There is an increasing interest internationally, especially from industry, to partner us for testing of commercial products.
The anterior segment optical coherence tomography (AS-OCT) is an imaging device that allows clinicians to acquire images of the conjunctivochalasis in a safe and non-invasive manner. The device utilizes infra-red light which is reflected on the eye surface. The reflection, affected by the thickness of the tissue, is then used to generate an image. It also was found to correlate with other less repeatable diagnostic tests, such as tear film break-up time (TBUT), which measures tear film stability.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 盲法
- None
入排标准
- 年龄范围
- 21 Years 至 —（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.
结局指标
主要结局
The repeatabilty of objective conjunctivochalasis measurements of HD-Cirrus AS-OCT from the same examiner, and between the two examiners
时间窗: 1 day
次要结局
未报告次要终点
研究者
Louis Tong
Clinician-Scientist, Senior Consultant
Singapore National Eye Centre