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

NCT05377099 | Completed

• 1 other identifier: MD 187-2020
• Study Type: interventional
• Target: 33
• Locations: 1 country
• Sites: 1

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.

Conditions

Corneal Biomechanics

Keywords

CORVIS - Corneal Biomechanics

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (3)

Laser In situ Keratomileusis (LASIK)

ACTIVE COMPARATOR

Measurement of the deformation amplitude ratio, integrated radius and stress strain index as corneal biomechanical indices in refractive patients before and after LASIK

Diagnostic Test: CORVIS

Femto-second assisted LASIK (FS-LASIK)

ACTIVE COMPARATOR

Measurement of the deformation amplitude ratio, integrated radius and stress strain index as corneal biomechanical indices in refractive patients before and after Femto LASIK

Diagnostic Test: CORVIS

Photorefractive Keratectomy (PRK)

ACTIVE COMPARATOR

Measurement of the deformation amplitude ratio, integrated radius and stress strain index as corneal biomechanical indices in refractive patients before and after PRK

Diagnostic Test: CORVIS

Interventions

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.

Femto-second assisted LASIK (FS-LASIK); Laser In situ Keratomileusis (LASIK); Photorefractive Keratectomy (PRK)

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Cairo University

Cairo, Egypt

Location

Study Officials

• Mohamed Hosny

  Cairo University

  PRINCIPAL INVESTIGATOR

• Mohamed Anis

  Cairo University

  STUDY DIRECTOR

• Wessam Salem

  Cairo University

  STUDY CHAIR

• Mohamed ELnaggar

  Research institute of Ophthalmology

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principle Investigator

Study Record Dates

• First Submitted: May 1, 2022
• First Posted: May 17, 2022
• Study Start: January 1, 2022
• Primary Completion: August 1, 2022
• Study Completion: January 30, 2023
• Last Updated: February 21, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)