NCT03500796

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

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

Enrollment
10

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Apr 2018

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

First Submitted

Initial submission to the registry

March 23, 2018

Completed
23 days until next milestone

Study Start

First participant enrolled

April 15, 2018

Completed
3 days until next milestone

First Posted

Study publicly available on registry

April 18, 2018

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2020

Completed
Last Updated

May 19, 2021

Status Verified

May 1, 2021

Enrollment Period

2.7 years

First QC Date

March 23, 2018

Last Update Submit

May 17, 2021

Conditions

Corneal Perforation

Outcome Measures

Primary Outcomes (1)

  • Closure of the corneal wound

    sealing of the edges corneal gap, with formation of scar tissue

    3 months

Study Arms (1)

Corneal perforation patients

OTHER

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 implantationProcedure: Wound closure with amniotic membrane

Interventions

Platelet rich plasma clot implantationPROCEDURE

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

Corneal perforation patients
Wound closure with amniotic membranePROCEDURE

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

Corneal perforation patients

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • central corneal perforation

You may not qualify if:

  • active infection
  • posterior segment pathology
  • non seeing eye

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of Medicine

Minya, Egypt

Location

MeSH Terms

Conditions

Corneal Perforation

Condition Hierarchy (Ancestors)

Corneal InjuriesEye InjuriesFacial InjuriesCraniocerebral TraumaTrauma, Nervous SystemNervous System DiseasesCorneal DiseasesEye DiseasesWounds and Injuries

Study Officials

  • Ahmed A Abdelghany, MD

    Assistant professor of Ophthalmology, Faculty of Medicine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer of Ophthalmology, Faculty of Medicine

Study Record Dates

First Submitted

March 23, 2018

First Posted

April 18, 2018

Study Start

April 15, 2018

Primary Completion

December 31, 2020

Study Completion

December 31, 2020

Last Updated

May 19, 2021

Record last verified: 2021-05

Data Sharing

IPD Sharing
Will not share

steps of technique and results

Locations

EG(1)