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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05377099
Other study ID # MD 187-2020
Secondary ID
Status Completed
Phase N/A
First received
Last updated
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
Health authority
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.

Study Design


Related Conditions & MeSH terms


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
See also
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