Corneal Endothelial Cell Injury Induced by Mitomycin-C | NCT05548478

Studies
Corneal Endothelial Cell Injury Induced by Mitomycin-C

NCT05548478

Sponsor

Al-Azhar University

Status

Unknown status

Last Update Posted

Sep 21, 2022Actual

Enrollment

60Estimated

Phase

Not Applicable

Conditions

Myopia

Interventions

Transepithelial PRK/MMC
Alcohol-Assisted PRK/MMC

Countries

Egypt

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2022

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 2022Estimated

Primary Completion Date

Feb 2023Estimated

Completion Date

Feb 2023Estimated

First Submitted Date

Sep 17, 2022

First Submission Date that Met QC Criteria

Sep 17, 2022

First Posted Date

Sep 21, 2022Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 17, 2022

Last Update Posted Date

Sep 21, 2022Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

60Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
TransEpi single step PRK	Active Comparator		Procedure: Transepithelial PRK/MMC
alcohol assisted PRK	Active Comparator		Procedure: Alcohol-Assisted PRK/MMC

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Transepithelial PRK/MMC	Procedure	transepithelial photorefractive keratectomy (PRK) and mitomycin C addition	TransEpi single step PRK

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

17 Years

Maximum Age

50 Years

Standard Ages

ChildAdult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Ehab tharwat	Recruiting	Damietta	New Damietta	34517	Egypt

Condition Browse Module

MeSH Terms

ID	Term
D009216	Myopia

Ancestor Terms

ID	Term
D012030	Refractive Errors
D005128	Eye Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D000431	Ethanol

Ancestor Terms

ID	Term
D000438	Alcohols
D009930	Organic Chemicals

Browse Leaves

Not provided

Browse Branches

Not provided