Analysis of the Diagnostic Performance of LacryDiag, a New "All-in-one" Non-contact Analyzer of the Ocular Surface in the Dry Eye. Study LACRYMOSA
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Break-Up-Time (BUT)
研究概览
简要总结
LacryDiag is a new Conformity European (CE) marked diagnostic imaging device devoted to the analysis of the ocular surface. It is an "all in one" device that provides 4 data: non-invasive break-up time (Non-Invasive Break-Up-Time (NIBUT) without fluorescein eye drop); height of the Tear Meniscus (TM); an infrared image of the meibomian glands; a picture of the lacrimal film by interferometry. it's performance will be compare between in diagnosing dry eye syndrome with the standard clinical evaluation, in 80 patients suffering from dry eye diseases and followed at the consultation of the Ophthalmology department of the University Hospital of Saint-Etienne.
详细描述
The primary purpose of this study is to compare the value of Break-Up-Time (BUT) between Non-Invasive Break-Up-Time (NIBUT) measured by LacryDiag and Standard Break-Up-Time (SBUT) measured by usual practice.
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
- 否
入选标准
- •Affiliates or beneficiaries of social security scheme
- •With Dry eye of any cause, diagnosed with conventional means
- •Signed informed consent
排除标准
- •Major blepharospasm
- •Serious illness preventing participation according to investigator
- •Allergy to fluorescein
- •Pregnant or / and breastfeeding women
- •Under guardianship, curatorship or safeguard of justice
- •Unable to express their consent
- •Person in emergency situation
研究组 & 干预措施
Patient with dry eye disease
Patient with dry eye disease will be included. They will have:
- Time #1: LacryDiag examination without dye
- Time #2: MicroInstillation Break-Up Time (MIBUT) + Oxford score
- Time #3: Standard Break-Up Time (SBUT)
- Time #4: Schirmer test
- Satisfaction questionnaire to the patient
干预措施: Time #1: Non Invasive Break-Up Time (NIBUT) (Diagnostic Test)
Patient with dry eye disease
Patient with dry eye disease will be included. They will have:
- Time #1: LacryDiag examination without dye
- Time #2: MicroInstillation Break-Up Time (MIBUT) + Oxford score
- Time #3: Standard Break-Up Time (SBUT)
- Time #4: Schirmer test
- Satisfaction questionnaire to the patient
干预措施: Time #2: MicroInstillation Break-Up Time (MIBUT) + Oxford score (Diagnostic Test)
Patient with dry eye disease
Patient with dry eye disease will be included. They will have:
- Time #1: LacryDiag examination without dye
- Time #2: MicroInstillation Break-Up Time (MIBUT) + Oxford score
- Time #3: Standard Break-Up Time (SBUT)
- Time #4: Schirmer test
- Satisfaction questionnaire to the patient
干预措施: Time #3: Standard Break-Up Time (SBUT) (Diagnostic Test)
Patient with dry eye disease
Patient with dry eye disease will be included. They will have:
- Time #1: LacryDiag examination without dye
- Time #2: MicroInstillation Break-Up Time (MIBUT) + Oxford score
- Time #3: Standard Break-Up Time (SBUT)
- Time #4: Schirmer test
- Satisfaction questionnaire to the patient
干预措施: Time #4: Schirmer test (Diagnostic Test)
Patient with dry eye disease
Patient with dry eye disease will be included. They will have:
- Time #1: LacryDiag examination without dye
- Time #2: MicroInstillation Break-Up Time (MIBUT) + Oxford score
- Time #3: Standard Break-Up Time (SBUT)
- Time #4: Schirmer test
- Satisfaction questionnaire to the patient
干预措施: Satisfaction questionnaire to the patient (Diagnostic Test)
结局指标
主要结局
Break-Up-Time (BUT)
时间窗: Day: 1
Comparison of Break-Up-Time (BUT) measured by 2 methods : LacryDiag Non Invasive Break-Up Time (NIBUT) and manual Standard Break-Up Time (SBUT). Measured in seconds by time#1: Non Invasive Break-Up Time (NIBUT) and time#3: Standard Break-Up Time (SBUT).
次要结局
- Tear Meniscus (TM) height and Schirmer test(Day: 1)
- Thickness (in nanometer) and regularity of lacrimal film (type)(Day: 1)
- Percentage loss of Meibomian Gland.(Day: 1)
- Standard Break-Up Time (SBUT)(Day: 1)
- MicroInstillation Break-Up Time (MIBUT)(Day: 1)