Combined Amniotic Membrane and Platelet Rich Plasma Clot for Management of Central Corneal Perforation

Sponsor

Minia University (Other)

Overall Status

Completed

CT.gov ID

NCT03500796

Collaborator

(none)

Enrollment

Location

Arm

32.6

Actual Duration (Months)

0.3

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Use of amniotic membrane(AMT) and platelet rich plasma (PRP) clot for closure of central corneal perforation

Condition or Disease	Intervention/Treatment	Phase
Corneal Perforation	Procedure: Platelet rich plasma clot implantation Procedure: Wound closure with amniotic membrane	N/A

Detailed Description

Use of amniotic membrane and platelet rich plasma clot for closure of central corneal perforation either post infective or posttraumatic

Study Design

Study Type:

Interventional

Actual Enrollment :

10 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Combined Amniotic Membrane and Platelet Rich Plasma Clot for Management of Central Corneal Perforation

Actual Study Start Date :

Apr 15, 2018

Actual Primary Completion Date :

Dec 31, 2020

Actual Study Completion Date :

Dec 31, 2020

Arms and Interventions

Arm	Intervention/Treatment
Other: Corneal perforation patients Patients who had/impeding corneal perforation due to melting of the cornea after infection with a corneal pathogen (bacterial or viral), with no previous surgical intervention. Patients will undergo: Platelet rich plasma clot implantation Wound closure with amniotic membrane	Procedure: Platelet rich plasma clot implantation Implantation of a platelet rich plasma clot, which is created from the plasma of the patients, and refrigerated to be inserted under the sealing amniotic membrane Procedure: Wound closure with amniotic membrane Closure of the corneal perforation with a synthetic amniotic membrane with a 2 mm safety margin

Arm

Intervention/Treatment

Other: Corneal perforation patients

Patients who had/impeding corneal perforation due to melting of the cornea after infection with a corneal pathogen (bacterial or viral), with no previous surgical intervention. Patients will undergo: Platelet rich plasma clot implantation Wound closure with amniotic membrane

Procedure: Platelet rich plasma clot implantation

Implantation of a platelet rich plasma clot, which is created from the plasma of the patients, and refrigerated to be inserted under the sealing amniotic membrane

Procedure: Wound closure with amniotic membrane

Closure of the corneal perforation with a synthetic amniotic membrane with a 2 mm safety margin

Outcome Measures

Primary Outcome Measures

Closure of the corneal wound [3 months]
sealing of the edges corneal gap, with formation of scar tissue

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

central corneal perforation

Exclusion Criteria:

active infection
posterior segment pathology
non seeing eye

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Faculty of Medicine	Minya		Egypt

Sponsors and Collaborators

Minia University

Investigators

Principal Investigator: Ahmed A Abdelghany, MD, Assistant professor of Ophthalmology, Faculty of Medicine

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Ahemd Abdelghany, Lecturer of Ophthalmology, Faculty of Medicine, Minia University

ClinicalTrials.gov Identifier:

NCT03500796

Other Study ID Numbers:

56-2/2018

First Posted:

Apr 18, 2018

Last Update Posted:

May 19, 2021

Last Verified:

May 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Corneal Perforation

Study Results

No Results Posted as of May 19, 2021