Corneal Endothelial Cell Injury Induced by Mitomycin-C

Sponsor
Al-Azhar University (Other)
Overall Status
Recruiting
CT.gov ID
NCT05548478
Collaborator
(none)
60
1
2
5
11.9

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
  • Procedure: Transepithelial PRK/MMC
  • Procedure: Alcohol-Assisted PRK/MMC
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
60 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Prevention
Official Title:
Corneal Endothelial Cell Injury Induced by Mitomycin-C in TransEpi Single Step and Alcohol Assisted Photorefractive Keratectomy PRK: A Comparative Study
Anticipated Study Start Date :
Sep 1, 2022
Anticipated Primary Completion Date :
Feb 1, 2023
Anticipated Study Completion Date :
Feb 1, 2023

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. Endothelial cell Density [Base line]

    will be measured by Specular microscopy

  2. Endothelial cell Density [at 1st month]

    will be measured by Specular microscopy

  3. Endothelial cell Density [at 3rd month]

    will be measured by Specular microscopy

Eligibility Criteria

Criteria

Ages Eligible for Study:
17 Years to 50 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Ehab tharwat Damieta New Damietta Egypt 34517

Sponsors and Collaborators

  • Al-Azhar University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Ehab tharwat, Dr, Al-Azhar University
ClinicalTrials.gov Identifier:
NCT05548478
Other Study ID Numbers:
  • Mitomycin-C
First Posted:
Sep 21, 2022
Last Update Posted:
Sep 21, 2022
Last Verified:
Sep 1, 2022
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Ehab tharwat, Dr, Al-Azhar University
Additional relevant MeSH terms:

Study Results

No Results Posted as of Sep 21, 2022