Effects of Laser Species and Ocular Antioxidant Activity on Postoperative Inflammation, Oxidative Stress and Visual Prognosis in Patients Undergoing Ophthalmic Surgery - a Comparative Study.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 1,000
- 试验地点
- 2
- 主要终点
- TAC in tears at 1 week
研究概览
简要总结
This trial hypothesized that novel laser refractive surgery techniques (LASIK, KLEx) or laser-assisted cataract surgery (FLACAS) could suppress postoperative inflammation and improve recovery in patients by reducing oxidative stress generated by the surgical procedure. It is also intended to verify whether the new laser technology is necessary for clinical use in groups with low antioxidant activity through the detection of antioxidant activity in the eyes of patients.
详细描述
Simultaneously measure total reactive oxygen species (ROS), antioxidant capacity (TAC) and ascorbic acid (AA) in aqueous humor (cataract surgery only) or tears. All patients underwent the same examination at our institution, including uncorrected visual acuity (UCVA), intraocular pressure (IOP), as well as central corneal thickness (CCT) with pneumatic tonometer, apparent refraction with autorefractor, and corneal curvature with keratometer. The axial length (AXL), anterior chamber depth (ACD) and lens thickness (LT) were measured by optical biometer.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •at least 20 years old
- •corneal refractive surgery or cataract surgery patients
排除标准
- •patients with eye infections
- •presence of severe retinal disease
- •presence of severe eye injury or severe ptosis
结局指标
主要结局
TAC in tears at 1 week
时间窗: Before the operation and 1 week after surgery.
Change of Total Antioxidant Capacity (TAC) from Baseline to 1 week after surgery.
TAC in tears at 1 month
时间窗: Before the operation and 1 month after surgery.
Change of Total Antioxidant Capacity (TAC) from Baseline to 1 month after surgery.
TAC in tears at 2 months
时间窗: Before the operation and 2 months after surgery.
Change of Total Antioxidant Capacity (TAC) from Baseline to 2 months after surgery.
TAC in tears at 3 months
时间窗: Before the operation and 3 months after surgery.
Change of Total Antioxidant Capacity (TAC) from Baseline to 3 months after surgery.
AA in tears at 1 week
时间窗: Before the operation and 1 week after surgery.
Change of Ascorbic Acid (AA) from Baseline to 1 week after surgery.
AA in tears at 1 month
时间窗: Before the operation and 1 month after surgery.
Change of Ascorbic Acid (AA) from Baseline to 1 month after surgery.
AA in tears at 2 months
时间窗: Before the operation and 2 months after surgery.
Change of Ascorbic Acid (AA) from Baseline to 2 months after surgery.
AA in tears at 3 months
时间窗: Before the operation and 3 months after surgery.
Change of Ascorbic Acid (AA) from Baseline to 3 months after surgery.
ROS in tears at 1 week
时间窗: Before the operation and 1 week after surgery.
Change of Reactive Oxygen Species (ROS) from Baseline to 1 week after surgery.
ROS in tears at 1 month
时间窗: Before the operation and 1 month after surgery.
Change of Reactive Oxygen Species (ROS) from Baseline to 1 month after surgery.
ROS in tears at 2 months
时间窗: Before the operation and 2 months after surgery.
Change of Reactive Oxygen Species (ROS) from Baseline to 2 moths after surgery.
ROS in tears at 3 months
时间窗: Before the operation and 3 months after surgery.
Change of Reactive Oxygen Species (ROS) from Baseline to 3 months after surgery.
TAC in aqueous humor at the next day
时间窗: Before the operation and one day after surgery.
Change of Total Antioxidant Capacity (TAC) in aqueous humor from Baseline to one day after surgery
AA in aqueous humor at the next day
时间窗: Before the operation and one day after surgery.
Change of Ascorbic Acid (AA) in aqueous humor from Baseline to one day after surgery
ROS in aqueous humor at the next day
时间窗: Before the operation and one day after surgery.
Change of Reactive Oxygen Species (ROS) in aqueous humor from Baseline to one day after surgery
次要结局
- BCVA(Before surgery)
- UCVA at 1 week(1 week after surgery)
- UCVA at 1 month(1 month after surgery)
- UCVA at 2 months(2 months after surgery)
- UCVA at 3 months(3 months after surgery)