Metabolomic Profile in Tear Film Samples of Patients With or Without Dry Eye Syndrome Before and After Cataract Surgery.
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 250
- 试验地点
- 1
- 主要终点
- Metabolomic and lipodomic profile
研究概览
简要总结
The primary objective is to determine possible implications of deviant tear film quality for optimal refractive precision in patients scheduled for cataract surgery.
The study consist of three separate arms where cataract patients will be separated in to Dry Eye Disease (DED) positive and negative groups. The DED positive group will be further subdivided into two different treatment groups (with focus on prolonged use of lubricant and preservative free eye drops). Tear film samples will be taken before treatment, after treatment and after surgical treatment and compared.
详细描述
The participants will be randomized to either standard pre- and postoperative treatment protocol - hereby called the standard protocol - or a pre- and postoperative protocol where intensive dry eye treatment is implemented - hereby called the intensive dry eye treatment protocol. The intensive dry eye treatment protocol differs from the standard protocol in the use of preservative free eye drops and the use of topical steroids prior to surgery.
The standard treatment protocol is:
Before surgery:
- Nevanac 3 mg /mL
- Spersadex 1mg/ml three days before surgery.
After surgery:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 40 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Indication for cataract surgery
- •Signed informed consent
- •no rheumatological or other systemic disease that involve the corneal surface
- •a good ocular health with no pathology that compromises visual acuity (except cataract).
排除标准
- •Manifest corneal disease or scarring
- •Lid deformities
- •Corneal ectasia
- •Rheumatoid diseases or other systemic diseases that involve the corneal surface,
- •Recent ocular surgery
- •Previous refractive procedures
- •Diabetic retinopathy
- •Subjects who have an acute or chronic disease or illness that would confound the results of this investigation (e.g., immunocompromised, connective tissue disease, clinically significant atopic disease, diabetes, and any other such disease or illness)
- •Pregnancy.
研究组 & 干预措施
Cataract patients with dry eye - standard treatment
Standard pre and postop medication, preservative eye drops.
干预措施: Preservative (Drug)
Cataract patients with dry eye - intensive treatment
More prolonged use of lubricant eye drops as well as the use of preservative free eye drops.
干预措施: Lubricant Eye Drops (Drug)
Cataract patients with dry eye - intensive treatment
More prolonged use of lubricant eye drops as well as the use of preservative free eye drops.
干预措施: Preservative Free (Drug)
Cataract patients without dry eye disease / control group
Standard pre and postop medication, control group.
干预措施: Preservative (Drug)
结局指标
主要结局
Metabolomic and lipodomic profile
时间窗: 6 weeks
The metabolomic and lipodomic profiles of the tears in each group will be measured. Relevant metabolic/lipid results will be reported.
次要结局
- Spherical equivalent refraction(6 weeks)
- Refractive cylinder(6 weeks)