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

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ClinicalTrials.gov Identifier: NCT03500796
Recruitment Status : Not yet recruiting
First Posted : April 17, 2018
Last Update Posted : April 17, 2018
Sponsor:
Information provided by (Responsible Party):
Ahemd Abdelghany, Minia University

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 Not Applicable

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

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 6 participants
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
Estimated Study Start Date : April 2018
Estimated Primary Completion Date : June 2018
Estimated Study Completion Date : September 2018

Arm Intervention/treatment
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




Primary Outcome Measures :
  1. Closure of the corneal wound [ Time Frame: 3 months ]
    sealing of the edges corneal gap, with formation of scar tissue



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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • central corneal perforation

Exclusion Criteria:

  • active infection
  • posterior segment pathology
  • non seeing eye

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03500796


Contacts
Contact: Ahmed A Abdelghany, MD 01020009630 ahmeda.abdelghany82@gmail.com

Sponsors and Collaborators
Minia University
Investigators
Principal Investigator: Ahmed A Abdelghany, MD Lecturer of Ophthalmology, Faculty of Medicine

Responsible Party: Ahemd Abdelghany, Lecturer of Ophthalmology, Faculty of Medicine, Minia University
ClinicalTrials.gov Identifier: NCT03500796     History of Changes
Other Study ID Numbers: 56-2/2018
First Posted: April 17, 2018    Key Record Dates
Last Update Posted: April 17, 2018
Last Verified: February 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: steps of technique and results

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Corneal Perforation
Corneal Injuries
Eye Injuries
Facial Injuries
Craniocerebral Trauma
Trauma, Nervous System
Nervous System Diseases
Corneal Diseases
Eye Diseases
Wounds and Injuries