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临床试验/NCT07550907
NCT07550907招募中不适用

The Impact of Surgical Procedures on Postoperative Outcomes in Cataract Phacoemulsification and Analysis of Related Factors

Zhongshan Ophthalmic Center, Sun Yat-sen University1 个研究点 分布在 1 个国家目标入组 300 人开始时间: 2026年4月20日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
300
试验地点
1
主要终点
Change in corneal thickness

研究概览

简要总结

The goal of this observational study is to evaluate the location of phacoemulsification tip measured by intraoperative OCT during cataract surgeries and its impact on early postoperative changes of cornea and visual acuity. The main question it aims to answer is:

In patients with age-related cataracts undergoing phacoemulsification, does the location (supracapsular, iris-lens diaphragm, or endocapsular) of the phaco tip affect postoperative corneal changes and visual acuity at early postoperative stage? Eyes having phacoemulsification for cataracts will receive intraoperative OCT imaging to evaluate the location of the phaco tip during surgery, and corneal changes and visual acuity will be measured postoperatively.

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
50 Years 至 90 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Age ≥ 50 years and ≤ 90 years
  • Diagnosis of unilateral/bilateral age-related cataract
  • Nuclear grade ≥2 in LOCSIII classification
  • Scheduled for cataract phacoemulsification combined with intraocular lens implantation
  • Pupil size ≥6mm after dilation
  • Corneal endothelial cell count ≥1500 cells/mm²

排除标准

  • Diagnosis of severe systemic disease (e.g., severe hypertension or Alzheimer's disease)
  • History of ocular trauma or surgery
  • Presence of other ocular diseases (such as glaucoma, diabetic retinopathy, or high myopia)
  • Other ocular factors that may complicate the surgery (such as small pupil, shallow anterior chamber)

研究组 & 干预措施

Phacoemulsification

干预措施: cataract surgery (Procedure)

结局指标

主要结局

Change in corneal thickness

时间窗: postoperative day 1, week 1, and month 1

Corneal thickness measured by corneal endothelial specular microscope

次要结局

  • Change in corneal endothelial cell density(1 day, 1 week, and 1 month postoperatively)
  • Best-corrected visual acuity(1 day, 1 week, and 1 month postoperatively)
  • Intraoperative and postoperative complications(Intraoperative, 1 day, 1 week, and 1 month postoperatively)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Zitian Liu

Dr.

Zhongshan Ophthalmic Center, Sun Yat-sen University

研究点 (1)

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