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临床试验/NCT02596919
NCT02596919终止不适用

Fast Infrared Meibography (Photography)

Queen Victoria Hospital NHS Foundation Trust2 个研究点 分布在 1 个国家目标入组 15 人开始时间: 2015年9月最近更新:
适应症

试验速览

阶段
不适用
状态
终止
入组人数
15
试验地点
2
主要终点
To examine for a correlation between morphologic changes in meibomian glands visible on infrared photography with clinical examination findings

研究概览

简要总结

Infrared meibography is a useful technique in the evaluation of meibomian gland disease (MGD). MGD is a major cause of dry eye symptoms, affecting a large number of patients seen in the Corneo-Plastic Unit (CPU). Many parameters have been used to evaluate MGD including tear film break-up time, lid margin abnormalities, and Schirmer tear test values. Direct visualization of meibomian glands by infrared meibography has been shown to correlate well with these parameters.

Although infrared meibography was developed more than 30 years ago, it is not widely used. This has probably been due to the need for special equipment, examiner time and expertise and patient discomfort during the examination. Analysis of the acquired images also needed to be from video review with extraction of video stills - a time-consuming process.

Investigators aim to pilot a rapid non-contact (non-painful) method of obtaining infrared images of meibomian glands using equipment already available at QVH. This pilot study will validate the technique and check patient acceptability. Investigators are hopeful this test could be used as a useful tool for future research into dry eye conditions and MGD.

详细描述

Patients will receive a patient information sheet in the post with their Eye Clinic appointment letter. To be clear, the points listed below would form the standard of care for a dry eye patient attending the clinic, apart from the additional infrared photographic image taken for the study (point 6).

In the Consultation room, the study will be explained to participants by one of the investigators. If they agree to participate, a consent form will be signed by the participant and an investigator. They will be questioned regarding the absence or presence of ocular symptoms using a previously validated and accepted scoring scale (Ocular Surface Disease Index - OSDI). This questionnaire will allow patients to score their degree of dry eye symptoms.

Participants will then undergo:

  1. Schirmers tear test of production.
  2. Clinical slit lamp examination to look for abnormalities of the upper and lower lid margins.
  3. Fluorescein staining of the ocular surface (divided into 3 zones comprising nasal conjunctival, corneal, and temporal conjunctival areas).
  4. Observation of tear film break-up time (TBUT).
  5. Digital pressure was applied to the upper tarsus, and the degree of ease with which meibomian secretion (meibum) is induced, evaluated semi-quantitatively. Eversion of upper and lower eyelids in the clinic is part of the standard ocular examination.
  6. In the photography department, the upper and lower eyelids will then be everted and non-contact infrared photographs taken. Partial or complete loss of Meibomian glands will be scored according to the meiboscore for each eyelid. After the image is taken, patient experience will be gathered on a five-point Lickert scale score sheet.

Outcome measures To examine for a correlation between morphologic changes in meibomian glands visible on infrared photography and both clinical examination findings and questionnaire scores regarding eyelid and tear film function in the population.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Diagnostic
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

结局指标

主要结局

To examine for a correlation between morphologic changes in meibomian glands visible on infrared photography with clinical examination findings

时间窗: 5 minutes

To examine for a correlation between morphologic changes in meibomian glands visible on infrared photography and both clinical examination findings and questionnaire scores regarding eyelid and tear film function in the population. Schirmer 1 Tear Test A Schirmer 1 test evaluates baseline secretion. 1. 0.5% proxymetacaine eye drops are administered to achieve topical anaesthesia. 2. Schirmer strips are then inserted into the lower conjunctival sac at the junction of the lateral and middle thirds, avoiding corneal touch. 3. All patients are seated at rest with their eyes closed. 4. The length of wetting strips in millimeters is recorded after 5 minutes. The Schirmer Test is interpreted after 5 minutes as follows: * Normal aqueous tear production is supported by measurements of \> 15 mm. * Mild-moderate reduction of aqueous production: 5mm-14mm. * Severe dryness due to reduced tear production is \< 5mm.

次要结局

  • To examine for a correlation between morphologic changes in meibomian glands visible on infrared photography with questionnaire scores(5 minutes)

研究者

申办方类型
Other Gov
责任方
Sponsor

研究点 (2)

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