Metabo-lipidomic Analysis of the Ocular Surface and Aqueous Humor for the Search of Predictive Biomarkers of Ocular Surface Disease After Cataract Surgery: a Prospective Cohort Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Postoperative ocular surface disease
研究概览
简要总结
Cataract is the world's leading cause of blindness, the treatment of which, exclusively surgical, offers excellent results in terms of visual recovery. It represents the most frequently performed surgery in France with more than 800,000 procedures each year. However, some patients develop postoperative ocular surface disease that can affect final visual acuity and quality of life. For example, dry eye disease, very common in the elderly, can be worsened by cataract surgery.
The identification of ocular surface biomarkers predictive of the postoperative risk of ocular surface disease carries the promise of better personalized perioperative care.
Conjunctival impression cytology represents a rapid, minimally invasive method of collecting conjunctival cells, which has proven its usefulness in the evaluation of diseases of the ocular surface. The aqueous humor is directly accessible at the beginning of the surgery.
An approach combining ultra-high performance liquid chromatography coupled with high-resolution mass spectrometry on the cells of the ocular surface and on the aqueous humor could improve our understanding of the physiopathology of ocular surface disease following cataract surgery.
This study will aim to 1) search for prognostic biomarkers of ocular surface disease after cataract surgery using a metabo-lipidomic approach 2) improve our understanding of the pathophysiological mechanisms involved.
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
- 50 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient with cortico-nuclear and/or subcapsular cataract
- •Age > or = 50 years
- •Patient affiliated to a social security system
- •Patient agreeing to participate in the study who provided his/her free and informed written consent
排除标准
- •History of ocular surgery or trauma (≤ 3 months)
- •Other types of cataract excepted age-related or diabetic cataract
- •Any eye drops or treatments that may interfere with the ocular surface
- •Lens wearer
- •Any general pathology with a known impact on the ocular surface (auto-immune disease, allergy)
- •Proven allergy to povidone-iodine or to a component of the postoperative treatment
- •Patient under legal protection (safeguard of justice, curatorship and guardianship), or in a situation of deprivation of freedom
- •Patient unable to understand the nature and objectives of the study
研究组 & 干预措施
Longitudinal cohort study in cataract patients
Longitudinal, open-label, single-center cohort study in cataract patients.
干预措施: Ocular Surface Disease Index (Other)
Longitudinal cohort study in cataract patients
Longitudinal, open-label, single-center cohort study in cataract patients.
干预措施: Interferometry (Other)
Longitudinal cohort study in cataract patients
Longitudinal, open-label, single-center cohort study in cataract patients.
干预措施: Oxford score (Other)
Longitudinal cohort study in cataract patients
Longitudinal, open-label, single-center cohort study in cataract patients.
干预措施: Conjunctival collection (Other)
Longitudinal cohort study in cataract patients
Longitudinal, open-label, single-center cohort study in cataract patients.
干预措施: Aqueous humor collection (Other)
Longitudinal cohort study in cataract patients
Longitudinal, open-label, single-center cohort study in cataract patients.
干预措施: Quantification of Tyndall and flare (Other)
结局指标
主要结局
Postoperative ocular surface disease
时间窗: 3 months after cataract surgery
Metabo-lipidomic analysis of intracellular content of the ocular surface preoperatively and aqueous humor intraoperatively to predict occurrence of ocular surface disease 3 months following cataract surgery.
Postoperative ocular surface disease
时间窗: 1 months after cataract surgery
Metabo-lipidomic analysis of intracellular content of the ocular surface preoperatively and aqueous humor intraoperatively to predict occurrence of ocular surface disease 1 month following cataract surgery.
次要结局
- Change in number and semi-quantitative concentrations of ocular surface metabolites(From baseline to 1 month after cataract surgery)
- Change in number and semi-quantitative concentrations of ocular surface lipids(From baseline to 1 month after cataract surgery)