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临床试验/NCT06818461
NCT06818461已完成不适用

Assessment of Corneal Biomechanical Properties Using Corvis ST and ECD Following LASIK, PRK, CXL, Veriflex IOL and Implantable Collamer Lens

Beni-Suef University2 个研究点 分布在 1 个国家目标入组 150 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
已完成
入组人数
150
试验地点
2
主要终点
corneal biomechanics

研究概览

简要总结

To evaluate corneal biomechanical changes using the Corvis ST and ECD in patients who have under-gone LASIK, PRK, corneal cross-linking (CXL), Veriflex IOL and ICL.

详细描述

This observational study aims to evaluate corneal biomechanical changes and ECD in patients who have undergone LASIK, PRK, corneal cross-linking (CXL), Veriflex IOL and ICL using the Corvis ST (Oculus) andEndocthelial cell Density . A total of 90 patients will be recruited from the ClearVision Laser Center database between January 2025 and December 2025. Participants will undergo non-contact biomechanical assessments at multiple postoperative time points to track corneal stability and elasticity over time.

Data Collection & Measurements Patient demographics, clinical history, and baseline preoperative data, including corneal thickness (pachymetry) and refractive status, will be collected. The Corvis ST will be used to measure key biomechanical parameters, such as Corneal Deformation Amplitude (CDA), Applanation Times (A1T & A2T), Radius of Curvature at Highest Concavity (RHC), Stiffness Parameter (SP-A1), Integrated Radius (IR), and the Corvis Biomechanical Index (CBI).

Measurement Protocol

All measurements will be conducted in a controlled environment with stable room temperature and humidity. Patients will be properly aligned, and three consecutive measurements per eye will be taken to ensure repeatability. Data will be recorded at specific intervals:

LASIK & PRK: 1 month, 3 months, 6 months, and 12 months CXL: 1 month, 3 months, 6 months, 12 months, and 24 months Veriflex and ICL : 1 month, 3 months, 6 months, 12 months, Potential Benefits & Risks The study aims to provide valuable insights into corneal biomechanical stability post-surgery, improving postoperative management and long-term visual outcomes. Risks are minimal, with only transient discomfort associated with the non-invasive Corvis ST measurements.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Prospective

入排标准

年龄范围
18 Years 至 60 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Adults aged 18-60 years.
  • Patients who have undergone LASIK, PRK, or CXL at least 1 month prior to measure-ment.
  • 3. Stable refraction for at least 3 months post-procedure.
  • No evidence of active ocular disease or infection.

排除标准

  • 1. History of other ocular surgeries (excluding LASIK, PRK, or CXL).
  • Presence of keratoconus or other corneal ectatic disorders not treated with CXL.
  • 3. Systemic or ocular conditions affecting corneal biomechanical properties (e.g., dia-betes, connective tissue disorders).
  • 4. Current or recent use of medications influencing corneal biomechanics.

结局指标

主要结局

corneal biomechanics

时间窗: 6 month

ECD measuments

时间窗: Preoperative and 6 month postoperative

corneal endothelial cell count measurments

次要结局

未报告次要终点

研究者

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

Mohamed Yasser Sayed Saif

Professour of Ophthalmology

Beni-Suef University

研究点 (2)

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