跳至主要内容
临床试验/NCT06993077
NCT06993077进行中(未招募)不适用

Association Between Ultraviolet Radiation, Environmental Factors, and Ocular Biomechanical Properties: A Multicenter Cross-Sectional Study

Tianjin Eye Hospital1 个研究点 分布在 1 个国家目标入组 3,000 人开始时间: 2025年1月1日最近更新:
适应症

试验速览

阶段
不适用
状态
进行中(未招募)
入组人数
3,000
试验地点
1
主要终点
Corneal Biomechanical Parameters Measured by Corvis ST

研究概览

简要总结

This observational study aims to explore whether ultraviolet (UV) radiation and other environmental factors are associated with ocular biomechanical properties in healthy volunteers aged 18-44 years without ocular diseases, ocular surgery history, or systemic diseases.

The main questions it aims to answer are:

Is there a significant correlation between UV radiation levels and corneal biomechanical parameters?

Do environmental factors such as geographic region and seasonal variation affect corneal biomechanical behavior?

Researchers will compare ocular biomechanical parameters among populations from different geographic regions with varying levels of UV radiation to determine whether there are statistically significant correlations or differences.

Participants will:

Undergo standardized ophthalmic examinations, including visual acuity, intraocular pressure, slit-lamp evaluation, axial length, and corneal topography;

Receive corneal biomechanical assessments using the Corvis ST device;

Provide basic demographic information and medical history;

Have all data de-identified, with the study strictly following ethical approval and privacy protection protocols.

研究设计

研究类型
Observational
观察模型
Ecologic Or Community
时间视角
Cross Sectional

入排标准

年龄范围
18 Years 至 44 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Inclusion Criteria
  • Age between 18 and 44 years (based on WHO criteria);
  • Spherical equivalent refraction (SER) ≤ 6.00 diopters;
  • No other ocular diseases;
  • No systemic diseases (e.g., diabetes, hypertension, cardiovascular diseases);
  • No severe psychiatric or psychological disorders;
  • No history of ocular surgery.
  • Exclusion Criteria
  • Severe psychiatric disorders;
  • Individuals diagnosed with keratoconus, suspected keratoconus, or subclinical keratoconus (based on the Global Consensus on Keratoconus Diagnosis);
  • Presence of other ocular diseases (e.g., glaucoma, corneal opacity, uveitis);
  • History of intraocular or ocular surface surgeries;
  • Presence of nystagmus or inability to cooperate with examinations;
  • History of intraocular surgery;
  • Presence of systemic diseases (e.g., diabetes, hypertension, cardiovascular diseases).

排除标准

  • Severe psychiatric disorders;
  • Individuals diagnosed with keratoconus, suspected keratoconus, or subclinical keratoconus (based on the Global Consensus on Keratoconus Diagnosis);
  • Presence of other ocular diseases (e.g., glaucoma, corneal opacity, uveitis);
  • History of intraocular or ocular surface surgeries;
  • Presence of nystagmus or inability to cooperate with examinations;
  • History of intraocular surgery;
  • Presence of systemic diseases (e.g., diabetes, hypertension, cardiovascular diseases).

结局指标

主要结局

Corneal Biomechanical Parameters Measured by Corvis ST

时间窗: Baseline (at time of examination)

,biomechanically corrected intraocular pressure (bIOP) mmHg

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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