Intraindividual Comparison of Prostaglandin E2 (PGE2) and Total-prostaglandin (PG) Following Femtosecond Laser-assisted Cataract Surgery Using a Low-energy, High-frequency Femtosecond Laser-Device in Regard to the Sequence of Anterior Capsulotomy and Lens Fragmentation
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 70
- 试验地点
- 2
- 主要终点
- Total-Prostaglandin and PGE2 level in aqueous humor
研究概览
简要总结
The investigational device is an approved femtosecond laser (FSL) device with an integrated imaging system to perform certain steps of the cataract procedure. The FSL will perform anterior capsulotomy and lens fragmentation in individuals suffering from age-related cataract with need of cataract surgery.
Cataract surgery will be performed in subjects who have signed an informed consent form. Aqueous humor will be collected and screening will be performed for Total Prostaglandin and Prostaglandin E2 via en-bloc Enzyme-linked Immunosorbent Assay (ELISA)-Kit.
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 procedure start.
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
- 否
入选标准
- •Bilateral age-related cataract necessitating phacoemulsification extraction and posterior intraocular lens implantation
- •Age: 40 to 90 (females of childbearing age will be interviewed if pregnancy is possible)
- •Preoperative pupil dilation in mydriasis ≥ 6.5 mm
排除标准
- •Preceding ocular surgery or trauma
- •Recurrent intraocular inflammation of unknown etiology
- •Uncontrolled glaucoma
- •Uncontrolled systemic or ocular disease
- •Blind fellow eye
- •Microphthalmus
- •Corneal abnormality
- •History of uveitis/iritis
- •Iris neovascularization
- •Pseudoexfoliation
- •Proliferative diabetic retinopathy
- •Pregnancy
- •Lactation
- •Females of childbearing age: not included
研究组 & 干预措施
Anterior Capsulotomy before Lens Fragmentation
Anterior capsulotomy will be performed by femtosecond laser before lens fragmentation
干预措施: Femtosecondlaser-assisted (Device)
Anterior Capsulotomy before Lens Fragmentation
Anterior capsulotomy will be performed by femtosecond laser before lens fragmentation
干预措施: Anterior Capsulotomy (Procedure)
Lens Fragmentation before Anterior Capsulotomy
Lens fragmentation will be performed by femtosecond laser before anterior capsulotomy
干预措施: Femtosecondlaser-assisted (Device)
Lens Fragmentation before Anterior Capsulotomy
Lens fragmentation will be performed by femtosecond laser before anterior capsulotomy
干预措施: Lens Fragmentation (Procedure)
结局指标
主要结局
Total-Prostaglandin and PGE2 level in aqueous humor
时间窗: 5 minutes after laser procedure (LCS)
pg/mL
次要结局
- Change in Pupilsize(baseline, immediately after laser, 5 min after laser)
研究者
Rupert Menapace
Prof. Dr. med. univ.
Medical University of Vienna