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

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.

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Key information

Conditions

Corneal Biomechanics

Age range

18 year–40 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Cairo University

Cairo, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

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

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.

Treatment and study plan

CORVIS

Diagnostic Test

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

Primary outcomes

Evaluation of the changes in DA ratio, integrated radius and SSI before and after LVC

Time frame: 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.

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Official study 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

Important dates

Study start: 2022
Primary completion: 2022
Study completion: 2023
First posted: May 17, 2022
Registry last updated: Feb 21, 2023

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.

Published trials that share one or more normalized conditions with this study.

Completed