Corneal PerforationNCT03500796
Combined Amniotic Membrane and Platelet Rich Plasma Clot for Management of Central Corneal Perforation
A study testing Platelet rich plasma clot implantation and Wound closure with amniotic membrane in people with Corneal Perforation, run by Minia University at 1 site in Egypt.
Trial summary
Use of amniotic membrane(AMT) and platelet rich plasma (PRP) clot for closure of central corneal perforation Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Corneal Perforation
- What is being tested?
- Platelet rich plasma clot implantation and Wound closure with amniotic membrane
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteEgypt
- Study dates
- 15 Apr 2018to 31 Dec 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- central corneal perforation
Who cannot join
- active infection
- posterior segment pathology
- non seeing eye
Trial locations and contacts
1 site in 1 country.
About this study
Use of amniotic membrane(AMT) and platelet rich plasma (PRP) clot for closure of central corneal perforation
Read the detailed description
Use of amniotic membrane and platelet rich plasma clot for closure of central corneal perforation either post infective or posttraumatic
- Conditions
- Corneal Perforation
- Being tested
- Platelet rich plasma clot implantation, Wound closure with amniotic membrane
- Medical subject headings
- Corneal Perforation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Platelet rich plasma clot implantationProcedure or surgery
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
Wound closure with amniotic membraneProcedure or surgery
Closure of the corneal perforation with a synthetic amniotic membrane with a 2 mm safety margin
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Procedure: Platelet rich plasma clot implantation; Procedure: Wound closure with amniotic membrane |
What is being measured
The primary outcome is the main question the study is designed to answer.
Closure of the corneal wound
sealing of the edges corneal gap, with formation of scar tissue
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Apr 2018
- Study start15 Apr 2018
- Primary completion31 Dec 2020
- Study completion31 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Corneal PerforationStudies of the same condition, open and under way.
- More trials run by Minia UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Minia University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahemd Abdelghany, Minia University
- Investigators
- Ahmed A Abdelghany, MD, Principal investigator, Assistant professor of Ophthalmology, Faculty of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03500796
- Sponsor's protocol ID
- 56-2/2018
- Status last verified
- May 2021
- First submitted
- 23 Mar 2018
- Last updated
- 19 May 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: steps of technique and results
Study at a glance
From the registry record, last updated by the sponsor on 19 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Combined Amniotic Membrane and Platelet Rich Plasma Clot for Management of Central Corneal Perforation
- ClinicalTrials.gov ID
- NCT03500796
- Acronym / sponsor ID
- 56-2/2018
- Conditions
- Corneal Perforation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Minia UniversityUniversity, hospital or other
- Study start
- 15 Apr 2018 (actual)
- Primary completion
- 31 Dec 2020 (actual)
- Study completion
- 31 Dec 2020 (actual)
- First posted
- 18 Apr 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Use of amniotic membrane(AMT) and platelet rich plasma (PRP) clot for closure of central corneal perforation
Detailed description
Use of amniotic membrane and platelet rich plasma clot for closure of central corneal perforation either post infective or posttraumatic
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Corneal perforation patients | Other | Procedure: Platelet rich plasma clot implantation, Procedure: Wound closure with amniotic membranePatients 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 |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- central corneal perforation
Key exclusion criteria (3 listed)
- active infection
- posterior segment pathology
- non seeing eye
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Platelet rich plasma clot implantationImplantation 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 or surgery | Corneal perforation patients |
| Wound closure with amniotic membraneClosure of the corneal perforation with a synthetic amniotic membrane with a 2 mm safety margin | Procedure or surgery | Corneal perforation patients |
Primary outcome
Closure of the corneal wound
Time frame: 3 months
sealing of the edges corneal gap, with formation of scar tissue
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 May 2021.
- Individual participant dataSharing planned: No. steps of technique and results
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ahmed A Abdelghany, MD principal investigator
Assistant professor of Ophthalmology, Faculty of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Platelet rich plasma clot implantation and Wound closure with amniotic membrane in people with Corneal Perforation, run by Minia University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 May 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Closure of the corneal wound (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 May 2021.