Validating the Diagnostic Accuracy of Mediview 2.0 Software as an Image Analysis Tool of Meibomian Glands
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- To certify the accuracy of the software
研究概览
简要总结
Non-contact meibography is a useful tool in assessing the health of meibomian glands in patients. Instead of using normal light in contact meibography, non-contact meibography utilises infra-red (IR) light. IR light is shined on patients' inverted eyelids and a special camera then allows visualisation of the structure of the meibomian glands, including the ducts and acini. Currently, images taken via non-contact meibography are manually analysed by a skilled clinician.
Knowledge of the health of meibomian glands is useful, especially in the diagnosis of Meibomian Gland Dysfunction (MGD). Studies have shown that MGD is one of the most common causes of evaporative dry eye.
Mediview 2.0 is a software that has been programmed to semi-automatically classify meibograph images taken via non-contact meibography. This software is collaboration with Shanghai MediWorks Precision Instruments Co., Ltd. The algorithm used was developed by a collaboration between Agency for Science, Technology and Research (A*STAR) and Singapore Eye Research Institute (SERI).
This current study aims to validate the diagnostic accuracy of Mediview 2.0 in assessing the health of meibomian glands of patients, against a trained clinician. We aim to recruit 100 participants for this study.
Once this software is found to be valid, a trained technician could be taught how to capture the images and hence leaving the doctors with more time to focus on clinical assessment and treatment instead. Therefore, this study has the potential to increase efficiency in the clinics.
详细描述
Meibomian gland dysfunction (MGD) is a chronic abnormality of the meibomian glands and commonly characterized by terminal meibomian duct obstruction and/or qualitative or quantitative changes in the glandular secretion. This may result in alteration of the composition and functioning of the tear film lipid layer, and subsequently destabilisation of the tear film. Studies have shown that MGD is one of the most common causes of evaporative dry eye.
It is recommended that the diagnosis of MGD be made by assessing ocular symptoms, lid morphology, mebomian gland mass, gland expressibility, lipid layer thickness and meibography. In meibography, the structure of the meibomian glands, including the ducts and acini can be observed. Photographic documentation of the meibomian gland is also possible under specialised illumination techniques.
There are two types of meibography currently in use- contact meibography and non-contact meibography. Non-contact meibography is advantageous over contact meibography as it is more comfortable for patients. In non-contact meibography, the slit-lamp microscope is equipped with an IR charge-coupled (CCD) device video camera and an IR transmitting filter. During the procedure, IR light is projected onto the inverted eyelid of the subject and the image of the eyelid captured by a camera.
Currently, skilled clinicians analyse images obtained via non-contact meibography manually to determine the health of the patient's eyelid. Through a collaborative project between scientists from bioinformatics institute, A*STAR, Singapore (Dr Lee Hwee Kuan) and SERI, semi-automatic algorithms for classifying meibographs into healthy and unhealthy have been previously developed. The commercial partner for this project, Mediworks, China, has incorporated these algorithms into the Mediview 2.0 software. This software consists of modules for acquiring meibography images as well as for analysing these images. Provided a user draws the outline of the tarsal plate on the captured image, the software is able to classify images into two categories- Healthy and Unhealthy without the aid of a skilled clinician. A trained technician could be taught how to capture the images and hence leaving the doctor with more time to focus on clinical assessment and treatment.
However, the accuracy and reproducibility of this software should be validated against a clinical assessor just as in the original algorithms. We propose to recruit 50 healthy volunteers and 50 patients from SNEC clinics and from public.
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 90 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy volunteers/ patients that are willing to participate in this study.
排除标准
- •Any other specified reason as determined by clinical investigator.
结局指标
主要结局
To certify the accuracy of the software
时间窗: 1 day
To validate the accuracy of Mediview 2.0 in classifying meibograph images (into Healthy and Unhealthy categories) and reproducibility of the classifications.
次要结局
未报告次要终点
研究者
Louis Tong
Clinician-Scientist, Senior Consultant
Singapore National Eye Centre
