NCT05548478

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2022

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2022

Completed
16 days until next milestone

First Submitted

Initial submission to the registry

September 17, 2022

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 21, 2022

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2023

Completed
Last Updated

September 21, 2022

Status Verified

September 1, 2022

Enrollment Period

5 months

First QC Date

September 17, 2022

Last Update Submit

September 17, 2022

Conditions

Myopia

Keywords

mytomycin

Outcome Measures

Primary Outcomes (3)

  • Endothelial cell Density

    will be measured by Specular microscopy

    Base line

  • Endothelial cell Density

    will be measured by Specular microscopy

    at 1st month

  • Endothelial cell Density

    will be measured by Specular microscopy

    at 3rd month

Study Arms (2)

TransEpi single step PRK

ACTIVE COMPARATOR
Procedure: Transepithelial PRK/MMC

alcohol assisted PRK

ACTIVE COMPARATOR
Procedure: Alcohol-Assisted PRK/MMC

Interventions

Transepithelial PRK/MMCPROCEDURE

transepithelial photorefractive keratectomy (PRK) and mitomycin C addition

TransEpi single step PRK
Alcohol-Assisted PRK/MMCPROCEDURE

photorefractive keratectomy (PRK) assisted by alchol and mitomycin C addition

alcohol assisted PRK

Eligibility Criteria

Age17 Years - 50 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ehab tharwat

Damietta, New Damietta, 34517, Egypt

RECRUITING

MeSH Terms

Conditions

Myopia

Interventions

Ethanol

Condition Hierarchy (Ancestors)

Refractive ErrorsEye Diseases

Intervention Hierarchy (Ancestors)

AlcoholsOrganic Chemicals

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr

Study Record Dates

First Submitted

September 17, 2022

First Posted

September 21, 2022

Study Start

September 1, 2022

Primary Completion

February 1, 2023

Study Completion

February 1, 2023

Last Updated

September 21, 2022

Record last verified: 2022-09

Locations

EG(1)