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

NCT ID: NCT05377099

Last Updated: 2023-02-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

33 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-01-01

Study Completion Date

2023-01-30

Brief Summary

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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

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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.

Conditions

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Corneal Biomechanics

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Laser In situ Keratomileusis (LASIK)

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

Group Type ACTIVE_COMPARATOR

CORVIS

Intervention Type 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)

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

Group Type ACTIVE_COMPARATOR

CORVIS

Intervention Type 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.

Photorefractive Keratectomy (PRK)

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

Group Type ACTIVE_COMPARATOR

CORVIS

Intervention Type 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.

Interventions

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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.

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Cairo University

OTHER

Sponsor Role lead

Responsible Party

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Wessam Salem

Principle Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Mohamed Hosny

Role: PRINCIPAL_INVESTIGATOR

Cairo University

Mohamed Anis

Role: STUDY_DIRECTOR

Cairo University

Wessam Salem

Role: STUDY_CHAIR

Cairo University

Mohamed ELnaggar

Role: STUDY_DIRECTOR

Research institute of Ophthalmology

Locations

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Cairo University

Cairo, , Egypt

Site Status

Countries

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Egypt

Other Identifiers

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MD 187-2020

Identifier Type: -

Identifier Source: org_study_id

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