Corneal Endothelial Cell Injury Induced by Mitomycin-C

September 17, 2022 updated by: Ehab tharwat, Al-Azhar University

Corneal Endothelial Cell Injury Induced by Mitomycin-C in TransEpi Single Step and Alcohol Assisted Photorefractive Keratectomy PRK: A Comparative Study

our study will investigate the effecacy of Mitomycin-C in TransEpi single step photorefractive keratectomy (PRK) and alcohol assisted PRK

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
    • New Damietta
      • Damieta, New Damietta, Egypt, 34517

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

17 years to 50 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Age over 18 years.
  • Primary myopia or compound myopic astigmatism.
  • Preoperative manifest refraction spherical equivalent (MRSE) within the range of -1.0 to 8 D
  • Stable refractive error for at least 12 months before the surgery.
  • Contact lens discontinuation for at least 3 weeks.
  • Estimated corneal stromal bed thickness of more than 300mm at the thinnest point

Exclusion Criteria:

  • Unwilling to participate in the study.
  • Previous ocular surgery
  • Any diagnosed ocular disease
  • History of ocular trauma

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: TransEpi single step PRK
Procedure: Transepithelial PRK/MMC
transepithelial photorefractive keratectomy (PRK) and mitomycin C addition
Active Comparator: alcohol assisted PRK
Procedure: Alcohol-Assisted PRK/MMC
photorefractive keratectomy (PRK) assisted by alchol and mitomycin C addition

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Endothelial cell Density
Time Frame: Base line
will be measured by Specular microscopy
Base line
Endothelial cell Density
Time Frame: at 1st month
will be measured by Specular microscopy
at 1st month
Endothelial cell Density
Time Frame: at 3rd month
will be measured by Specular microscopy
at 3rd month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Al-Azhar University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

September 1, 2022

Primary Completion (Anticipated)

February 1, 2023

Study Completion (Anticipated)

February 1, 2023

Study Registration Dates

First Submitted

September 17, 2022

First Submitted That Met QC Criteria

September 17, 2022

First Posted (Actual)

September 21, 2022

Study Record Updates

Last Update Posted (Actual)

September 21, 2022

Last Update Submitted That Met QC Criteria

September 17, 2022

Last Verified

September 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Mitomycin-C

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Myopia

Clinical Trials on Transepithelial PRK/MMC

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Germany

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe