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Corneal Endothelial Cell Injury Induced by Mitomycin-C

Primary Purpose

Myopia

Status
Recruiting
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Transepithelial PRK/MMC
Alcohol-Assisted PRK/MMC
Sponsored by
Al-Azhar University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Myopia focused on measuring mytomycin

Eligibility Criteria

17 Years - 50 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Ehab tharwatRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

TransEpi single step PRK

alcohol assisted PRK

Arm Description

Outcomes

Primary Outcome Measures

Endothelial cell Density
will be measured by Specular microscopy
Endothelial cell Density
will be measured by Specular microscopy
Endothelial cell Density
will be measured by Specular microscopy

Secondary Outcome Measures

Full Information

First Posted
September 17, 2022
Last Updated
September 17, 2022
Sponsor
Al-Azhar University
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1. Study Identification

Unique Protocol Identification Number
NCT05548478
Brief Title
Corneal Endothelial Cell Injury Induced by Mitomycin-C
Official Title
Corneal Endothelial Cell Injury Induced by Mitomycin-C in TransEpi Single Step and Alcohol Assisted Photorefractive Keratectomy PRK: A Comparative Study
Study Type
Interventional

2. Study Status

Record Verification Date
September 2022
Overall Recruitment Status
Recruiting
Study Start Date
September 2022 (Anticipated)
Primary Completion Date
February 2023 (Anticipated)
Study Completion Date
February 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Al-Azhar University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Myopia
Keywords
mytomycin

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
TransEpi single step PRK
Arm Type
Active Comparator
Arm Title
alcohol assisted PRK
Arm Type
Active Comparator
Intervention Type
Procedure
Intervention Name(s)
Transepithelial PRK/MMC
Intervention Description
transepithelial photorefractive keratectomy (PRK) and mitomycin C addition
Intervention Type
Procedure
Intervention Name(s)
Alcohol-Assisted PRK/MMC
Intervention Description
photorefractive keratectomy (PRK) assisted by alchol and mitomycin C addition
Primary Outcome Measure Information:
Title
Endothelial cell Density
Description
will be measured by Specular microscopy
Time Frame
Base line
Title
Endothelial cell Density
Description
will be measured by Specular microscopy
Time Frame
at 1st month
Title
Endothelial cell Density
Description
will be measured by Specular microscopy
Time Frame
at 3rd month

10. Eligibility

Sex
All
Minimum Age & Unit of Time
17 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Ehab tharwat
City
Damieta
State/Province
New Damietta
ZIP/Postal Code
34517
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
ehab tharwat, MD
Phone
01006952497
Ext
02
Email
ehabtharwat71@gmail.com

12. IPD Sharing Statement

Learn more about this trial

Corneal Endothelial Cell Injury Induced by Mitomycin-C

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