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OpenTrials
Completed

NCT Number: NCT06818461

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

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.

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Key information

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Clearvision

Mohandessin, Giza Governorate, 11344, Egypt

About this study

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.

This study will contribute to a better understanding of corneal biomechanics in refractive and therapeutic procedures, potentially guiding future surgical decisions and patient care strategies.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 1. Adults aged 18-60 years. 2. Patients who have undergone LASIK, PRK, or CXL at least 1 month prior to measure-ment.
  • Stable refraction for at least 3 months post-procedure. 4. No evidence of active ocular disease or infection.

Exclusion criteria

  • 1. History of other ocular surgeries (excluding LASIK, PRK, or CXL). 2. Presence of keratoconus or other corneal ectatic disorders not treated with CXL.
  • Systemic or ocular conditions affecting corneal biomechanical properties (e.g., dia-betes, connective tissue disorders).
  • Current or recent use of medications influencing corneal biomechanics.

Treatment and study plan

Corvis St Before and after lasik, PRK, CXL, Veriflex IOL and ICL

Other

corneal biomechanics measurment using corvis St and corneal endothelial cell counts

Primary outcomes

  1. corneal biomechanics

    Time frame: 6 month

  2. ECD measuments

    Time frame: Preoperative and 6 month postoperative

    corneal endothelial cell count measurments

Sponsors and collaborators

Lead sponsor

Beni-Suef University

Other

Registry information

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Feb 10, 2025
Registry last updated
Jul 2, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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