Evaluation of the Change in the DA Ratio, IR and SSI as Parameters of Corneal Biomechanics Post Different LVC Procedures

Corneal Biomechanics Clinical Trial

Official title:

Evaluation of the Change in the Deformation Amplitude Ratio, Integrated Radius and Stress Strain Index as Parameters of Corneal Biomechanics Post Different Laser Vision Correction Procedures

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05377099
• Other study ID #: MD 187-2020
• Status: Completed
• Phase: N/A
• Start date: January 1, 2022
• Est. completion date: January 30, 2023

Study information

• Verified date: February 2023
• Source: Cairo University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

In the study, The Investigators will compare the participates' corneal biomechanical properties including: Deformation Amplitude ratio (Da Ratio) Integrated Radius (IR) Stress strain index (SSI) All measurements will be taken before and after 3 months of LVC.

Description:

Each Participant will undergo preoperative pentacam and corvis scan for his eyes and the 3 months post operative. The participants are divided into 3 groups, one who underwent LASIK, one PRK and one Femto LASIK. Collected data will before and after surgery will be compared in each arm and then the 3 arms will be compared together.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 33
• Est. completion date: January 30, 2023
• Est. primary completion date: August 1, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 40 Years

Eligibility

Inclusion Criteria:

• • Age range 18 - 40 years.
• Normal eyes with normal tomographic indices.
• Patients with maximum mean refractive spherical equivalent (MRSE) of -7.00 diopters and with maximum astigmatism of -3.00 diopters.

Exclusion Criteria:

• • Patients with any other coexisting corneal diseases.
• Keratoconus eyes.
• Eyes with previous refractive corneal surgery.
• Patients with increased intraocular pressure.

Related Conditions & MeSH terms

• Corneal Biomechanics

Intervention

Diagnostic Test:
• CORVIS
Measurement of the DA ratio, IR and SSI before and after for patients under gone LASIK, femto LASIK and PRK using the CORVIS device.

Locations

Country	Name	City	State
Egypt	Cairo University	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Evaluation of the changes in DA ratio, integrated radius and SSI before and after LVC	Comparison between in DA ratio (DA ratio) in patients undergoing LASIK, Femto LASIK and PRK.; Comparison between changes in integrated Radius (IR) in patients undergoing LASIK, Femto LASIK and PRK.; Comparison between changes in Stress strain index (SSI) in patients undergoing LASIK, Femto LASIK and PRK.; Each indices will be compared before and after the Laser vision correction (LVC) procedure and the indices are not to be compared to each other to have have a fixed unit measure.; I reviewed your comment and I dont see any conflicts, to clarify how multiple measurements will be aggregated to arrive at one reported value again I am going to measure each index and compare it with "itself' before and after 3 different LVC.	3-6 months post operative