Intraindividual Comparison of Proinflammatory Cytokines (IL-1β, IL-6) and Total-prostaglandin (PG) Following Femtosecond Laser-assisted Cataract Surgery Using a Low-energy, High-frequency Femtosecond Laser-Device Compared to Manual Cataract Surgery
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Proinflammatory cytokines (IL-1β, IL-6) and total-PG
研究概览
简要总结
Patients with bilateral age related cataract will be included in the study. Manual cataract surgery (MCS) will be performed in one eye and laser cataract surgery (LCS) in the corresponding eye. LCS will be performed with an approved femtosecond laser (FSL) device with an integrated imaging system.
After surgery aqueous humour will be collected and screened with Enzyme-linked Immunosorbent Assay (ELISA) Kits for Interleukin-1β; Interleukin-6 and PG.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
盲法说明
Groups will be randomized. Randomization information will be put in a sealed envelope on screening date and opened in operating theatre right before the surgery.
入排标准
- 年龄范围
- 40 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Bilateral age-related cataract necessitating phacoemulsification extraction and posterior intraocular lens implantation.
- •Pupil dilation of ≥ 6.5mm
- •Age 40 and older
排除标准
- •Corneal abnormality
- •Pseudoexfoliation
- •Preceding ocular surgery or trauma
- •Uncontrolled glaucoma
- •Proliferative diabetic retinopathy
- •Iris neovascularization
- •History of uveitis/iritis
- •Microphthalmus
- •Recurrent intraocular inflammation of unknown etiology
- •Blind fellow eye
- •Uncontrolled systemic or ocular disease
- •Pregnancy
- •Lactation
研究组 & 干预措施
LCS
Laser cataract surgery will be performed. 5-minutes after LCS aqueous humour will be collected and frozen in -80° celsius.
干预措施: Femtosecond Laser-assisted (Device)
MCS
Manual cataract surgery will be performed. Aqueous humour will be collected and frozen in -80° celsius before MCS starts.
干预措施: Manual Cataract Surgery (Procedure)
结局指标
主要结局
Proinflammatory cytokines (IL-1β, IL-6) and total-PG
时间窗: 5 minutes after laser procedure
Interleukin IL-1β, Interleukin IL-6, total-prostaglandin
次要结局
未报告次要终点
研究者
Rupert Menapace
Clinical Professor
Medical University of Vienna