Trials Sponsors Conditions Drugs Pricing

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

Interventions

CORVISDiagnostic 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)

Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

Eligibility Criteria

Age18 Years - 40 Years

Sexall

Healthy VolunteersYes

Age GroupsAdult (18-64)

You may qualify if:

Age range 18 - 40 years.
Normal eyes with normal tomographic indices.

Sponsors & Collaborators

Cairo University
Otherlead

Study Sites (1)

Cairo University

Cairo, Egypt

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

Enrollment

33 participants (actual enrollment reported by the registry).

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

Actual (reported)

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

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Study Arms (3)

Laser In situ Keratomileusis (LASIK)

Femto-second assisted LASIK (FS-LASIK)

Photorefractive Keratectomy (PRK)

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Study Arms (3)

Laser In situ Keratomileusis (LASIK)

Femto-second assisted LASIK (FS-LASIK)

Photorefractive Keratectomy (PRK)

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Locations