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临床试验/NCT05905237
NCT05905237已完成不适用

Effects of Laser Species and Ocular Antioxidant Activity on Postoperative Inflammation and Visual Prognosis in Patients Undergoing Ophthalmic Surgery - a Comparative Study

Chang Gung Memorial Hospital2 个研究点 分布在 1 个国家目标入组 132 人开始时间: 2022年7月12日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
132
试验地点
2
主要终点
Change of Total Antioxidant Capacity (TAC) in aqueous humor from Baseline to one day after surgery.

研究概览

简要总结

This trial hypothesized that novel laser refractive surgery techniques (PRK, LASIK, SMILE) 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.

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

入选标准

  • over 20 years old (included)
  • 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

Change of Total Antioxidant Capacity (TAC) in aqueous humor from Baseline to one day after surgery.

时间窗: During the operation and one day after surgery.

Change of Ascorbic Acid (AA) in tears from Baseline to 1 month after surgery.

时间窗: Before the operation and 1 month after surgery.

Change of Total Antioxidant Capacity (TAC) in tears from Baseline to 3 months after surgery.

时间窗: Before the operation and 3 months after surgery.

Change of Total Antioxidant Capacity (TAC) in tears from Baseline to 1 week after surgery.

时间窗: Before the operation and 1 week after surgery.

Change of Total Antioxidant Capacity (TAC) in tears from Baseline to 1 month after surgery.

时间窗: Before the operation and 1 month after surgery.

Change of Total Antioxidant Capacity (TAC) in tears from Baseline to 6 months after surgery.

时间窗: Before the operation and 6 months after surgery.

Change of Ascorbic Acid (AA) in tears from Baseline to 6 months after surgery.

时间窗: Before the operation and 6 months after surgery.

Change of Ascorbic Acid (AA) in aqueous humor from Baseline to one day after surgery.

时间窗: During the operation and one day after surgery.

Change of Ascorbic Acid (AA) in tears from Baseline to 1 week after surgery.

时间窗: Before the operation and 1 week after surgery.

Change of Ascorbic Acid (AA) in tears from Baseline to 3 months after surgery.

时间窗: Before the operation and 3 months after surgery.

次要结局

  • Examination of best corrected visual acuity (BCVA).(Before the operation.)
  • Examination of anterior chamber depth (ACD).(Before the operation.)
  • Examination of corneal curvature.(One month after surgery.)
  • Examination of uncorrected visual acuity (UCVA).(One month after surgery.)
  • Examination of central corneal thickness (CCT).(One month after surgery.)
  • Examination of lens thickness (LT).(Before the operation.)
  • Examination of intraocular pressure (IOP).(One month after surgery.)
  • Examination of axial length (AXL).(Before the operation.)
  • Examination of manifest refraction.(One month after surgery.)

研究者

发起方
Chang Gung Memorial Hospital
申办方类型
Other
责任方
Sponsor

研究点 (2)

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