Comparative Study on Changes in Anterior Chamber Cytokines, Oxidative Stress, and Pupil Size After LenSx and Z8 Femtosecond Lasers
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 发起方
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- PGE2
研究概览
简要总结
Femtosecond laser-assisted cataract surgery is rapidly gaining popularity. Among the 5 femtosecond laser platforms available at present for cataract surgery, the Femto LDV Z8 (Ziemer Ophthalmic Systems AG) is a high-frequency system and delivers energy pulses in nanojoule levels, while Lensx platform (Lensx, Alcon Laboratories, Inc.) used a high-energy laser system. In femtosecond laser-assisted cataract surgery, the laser pretreatment is associated with breakdown of blood-aqueous barrier (BAB) associated with increased aqueous total prostaglandin, cytokines and Oxygen-free radicals concentration. The prostaglandin rise immediately after laser pretreatment is further thought to be the causative factor for the intraoperative miosis in femtosecond laser-assisted cataract surgery. However, the analysis of anterior chamber inflammatory factors, oxidative stress, and pupil size after femtosecond laser-assisted cataract surgery between different laser platforms has not been investigated in clinical studies. Understanding the cytokine and chemokine changes related to the laser pretreatment provides better insight into the inflammatory response in femtosecond laser-assisted cataract surgery.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 50 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age related cataracts over 50 years old, nuclear grades II-III
排除标准
- •Eye diseases: glaucoma, uveitis
- •Systemic diseases: autoimmune diseases such as diabetes and rheumatism ③ Intraoperative complications: ④ Medication history: Over 1 month before surgery, systemic or local hormones, NASIDs ⑤ History of eye surgery (including YAG laser and fundus laser), trauma
结局指标
主要结局
PGE2
时间窗: through study completion, an average of half a year
The concentrations of PGE2 in aqueous humor
cytokines (IL-1β、IL-6, IL-8、TNF-a)
时间窗: through study completion, an average of half a year
The concentrations of cytokines (IL-1β、IL-6, IL-8、TNF-a) in aqueous humor
MDA
时间窗: through study completion, an average of half a year
The concentrations of MDA in aqueous humor
次要结局
- central corneal thickness(through study completion, an average of half a year)
- central macular thickness(through study completion, an average of half a year)