Ignite Creation Date:
2025-12-24 @ 12:06 PM
Ignite Modification Date:
2025-12-27 @ 3:06 PM
Study NCT ID:
NCT06818461
Status:
COMPLETED
Last Update Posted:
2025-11-19
First Post:
2025-02-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Assessment of Corneal Biomechanical Properties Using Corvis ST Following LASIK, PRK, and CXL
Sponsor:
Beni-Suef University
Organization:
Study Overview
Official Title:
Assessment of Corneal Biomechanical Properties Using Corvis ST Following LASIK, PRK, and CXL
Status:
COMPLETED
Status Verified Date:
2025-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
To evaluate corneal biomechanical changes using the Corvis ST in patients who have under-gone LASIK, PRK, and corneal cross-linking (CXL).
Detailed Description:
This observational study aims to evaluate corneal biomechanical changes in patients who have undergone LASIK, PRK, and corneal cross-linking (CXL) using the Corvis ST (Oculus). 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 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.
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 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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: