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临床试验/NCT07534436
NCT07534436招募中不适用

A Prospective Cohort Study on Visual Function and Psychological Conditions Before and After Surgery for Congenital Ptosis

Zhongshan Ophthalmic Center, Sun Yat-sen University1 个研究点 分布在 1 个国家目标入组 73 人开始时间: 2025年6月1日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
73
试验地点
1
主要终点
stereoacuity

研究概览

简要总结

The goal of this observational study is to learn about the 6-month effects of Levator Resection combined with Fascial Sheath Suspension surgery in patients who undergo this procedure to treat congenital ptosis. The main questions it aims to answer are:

Does this combined surgery improve best-corrected visual acuity, stereopsis, and other visual function indicators in patients with congenital ptosis within 6 months after the operation?

Does this surgery lead to an improvement in patient-reported quality of life during the same period?

Patients already scheduled to undergo this combined surgery as part of their regular medical care for congenital ptosis will complete a series of standardized ophthalmological examinations and a quality of life questionnaire before surgery and at 1, 3, and 6 months post-operation.

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
3 Years 至 60 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • Unilateral or bilateral congenital ptosis, male or female;
  • Age: 3-60 years old
  • Informed consent, and voluntary signing of the informed consent form, in compliance with ethical norms

排除标准

  • 未提供

研究组 & 干预措施

ptosis group

control group

结局指标

主要结局

stereoacuity

时间窗: From enrollment to 6 months after surgery

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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