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

Not Applicable

Completed

• Conditions: Corneal Biomechanics

• Registration Number: NCT05377099
• Lead Sponsor: Cairo University

Brief 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.

Detailed 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.

Study Timeline

• Study Start: 2022-01-01
• Study First Submitted: 2022-05-01
• Study First Submitted QC: 2022-05-12
• Study First Posted: 2022-05-17
• Primary Completion: 2022-08-01
• Study Completion: 2023-01-30
• Status Verified: 2023-02
• Last Update Submitted: 2023-02-19
• Last Update Posted: 2023-02-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 33

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Evaluation of the changes in DA ratio, integrated radius and SSI before and after LVC	3-6 months post operative	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.

Trial Locations

Locations (1)

Cairo University; 🇪🇬 Cairo, Egypt