Dry Eye Syndrome Description During Cataract Surgery, With Multimodal Analysis of the Ocular Surface
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- The main objective is to describe the characteristics of dry eye syndrome before and after surgery at one month of cataract surgery, using a multimodal analysis of the ocular surface.
研究概览
简要总结
The main objective is to describe the characteristics of dry eye syndrome before and after surgery at one month of cataract surgery, using a multimodal analysis of the ocular surface.
The secondary objectives are to evaluate:
- Predictive factors of dry eye syndrome during cataract surgery:
- The characteristics of dry eye syndrome
- Implications for the patient's quality of life
详细描述
Type of study: Descriptive study, interventional research involving the human person at risk and with minimal constraints (type 2), prospective, with longitudinal cohort follow-up, mono-centric.
Number of centres: 1; The protocol will take place in the ophthalmology department of the Clermont-Ferrand University Hospital.
Study description: The study will follow the normal protocol for cataract surgery. Patients will not have any additional consultation to perform this study. The classic consultation scheme involves a preoperative appointment to set the surgical indication and inform patients about the procedure, the benefits - risks and usual follow-up.. During this consultation, the patient will have to complete a quality of life questionnaire in addition to the standard protocol, and will also have to perform a non-invasive Schirmer test and a non-contact examination of the ocular surface analysis (Lacrydiag from the Quantel laboratory, with CE marking). The patient will be seen again in a traditional post-operative consultation one month after the surgery, the same examinations will be performed.
We will use the pre and postoperative ophthalmological consultation reports, the operative report, as well as a patient questionnaire and surface analysis examination reports to conduct the study.
Main judgment criteria:
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
- 是
入选标准
- •Adult patients (≥ 18 years old)
- •consultants to benefit from a scheduled cataract operation at Clermont Ferrand University Hospital
- •affiliation to a social security scheme
- •ability to give informed consent to participate in the study.
排除标准
- •- Patient without cataract surgery
- •Congenital cataract
- •Refusal to participate in the study
- •Inability to answer the questionnaire (cognitive impairment, comprehension difficulties...)
- •Eyelid abnormalities that may cause palpebral unocclusion
- •Patient under judicial protection (guardianship, curatorship, measure to safeguard justice) or deprived of liberty
- •inability to recheck the patient
结局指标
主要结局
The main objective is to describe the characteristics of dry eye syndrome before and after surgery at one month of cataract surgery, using a multimodal analysis of the ocular surface.
时间窗: Change from Baseline one month after surgery
Definition and classification of a dry eye syndrome according to different severity grades with an analysis of the ocular surface
次要结局
- Consequences on the patient's quality of life (translated questionnaire from the Ocular Surface Disease Index from 0 to 48)(Day 1, Day 30)
- Predictive factors of dry eye syndrome during cataract surgery(Day 1, Day 30)
- The characteristics of dry eye syndrome(Day 1, Day 30)