Corneal Endothelial Cell Injury Induced by Mitomycin-C

NCT ID: NCT05548478

Last Updated: 2022-09-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-09-30

Study Completion Date

2023-02-28

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Myopia

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

TransEpi single step PRK

Group Type ACTIVE_COMPARATOR

Transepithelial PRK/MMC

Intervention Type PROCEDURE

transepithelial photorefractive keratectomy (PRK) and mitomycin C addition

alcohol assisted PRK

Group Type ACTIVE_COMPARATOR

Alcohol-Assisted PRK/MMC

Intervention Type PROCEDURE

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Transepithelial PRK/MMC

transepithelial photorefractive keratectomy (PRK) and mitomycin C addition

Intervention Type PROCEDURE

Alcohol-Assisted PRK/MMC

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

Intervention Type PROCEDURE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

17 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Al-Azhar University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Ehab tharwat

Dr

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Ehab tharwat

Damietta, New Damietta, Egypt

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

Egypt

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

ehab tharwat, MD

Role: primary

01006952497 ext. 02

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

Mitomycin-C

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Endothelial Cell Loss After Penetrating Keratoplasty
NCT04457063 COMPLETED PHASE2/PHASE3
Low Dose Atropine Eye Drops in Myopic Egyptian Children
NCT06265454 NOT_YET_RECRUITING PHASE2