Corneal PerforationOCTNCT06422897
Role of AS-OCT in Assessment of Corneal Perforation
An observational study of Corneal Perforation, run by Minia University at 1 site in Egypt.
Trial summary
Assessment of healing of thin and perforated cornea after surgical treatment by anterior segment optical coherence tomography Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Corneal Perforation
- What is being tested?
- anterior segment optical coherence tomography
- How many people
- 13 participants
- Where
- 1 siteEgypt
- Study dates
- 15 Apr 2024to 5 Jun 2024
- Phase
- Observational
- 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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: patients from both sexes was thin cornea or small corneal perforation surgically treated by amniotic membrane graft and platelet rich plasma clot
Who may be able to join
- thin cornea about to perforate
- small corneal perforation
Who cannot join
- active infection
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Role of Anterior Segment Optical Coherence Tomography in Assessment of Healing of Thin or Perforated Cornea Treated by Amniotic Membrane Graft and Platelet Rich Plasma Clot
Assessment of healing of thin and perforated cornea after surgical treatment by anterior segment optical coherence tomography
Read the detailed description
- thin and perforated cornea (small perforation) is surgically treated by amniotic membrane graft and platelet rich plasma clot
- anterior segment optical coherence tomography is performed preoperative and 1 month postoperative to assess healing
- Conditions
- Corneal Perforation
- Being tested
- anterior segment optical coherence tomography
- Medical subject headings
- Corneal Perforation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
anterior segment optical coherence tomographyOther
surgically treated corneal perforation by amniotic membrane graft and platelet rich plasma clot is assessed by anterior segment optical coherence tomography 1 month postoperative
| Study group | Role | What they receive |
|---|---|---|
| cases after surgical management | cases are assessed by Anterior segment optical coherence tomography 1 month after surgical managemnt Receives: Other: anterior segment optical coherence tomography |
What is being measured
The primary outcome is the main question the study is designed to answer.
Depth of corneal healing measured by optical coherence tomography
complete corneal healing by anterior segment optical coherence tomography
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 May 2024
- Study start15 Apr 2024
- Primary completion30 May 2024
- Study completion5 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 13 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, professor, Principal investigator, professor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06422897
- Sponsor's protocol ID
- 1133/04/2024
- Acronym
- OCT
- Status last verified
- Jul 2024
- First submitted
- 15 May 2024
- Last updated
- 23 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Abdelghany AA, Bahrawy ME, Alio JL. Combined Platelet Rich Plasma and Amniotic membrane in the treatment of Perforated Corneal Ulcers. Eur J Ophthalmol. 2022 Jul;32(4):2148-2152. doi: 10.1177/11206721211049100. Epub 2021 Oct 8.
PubMed 34623187Khalafallah AM, Abdelghany AA, Alio JL, Abdelmonem AA, Mahmoud MSE. Role of AS-OCT in assessment of healing of thin or perforated cornea treated by amniotic membrane graft and PRP clot. BMC Ophthalmol. 2025 Dec 1;25(1):688. doi: 10.1186/s12886-025-04495-w.
PubMed 41327137
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Role of Anterior Segment Optical Coherence Tomography in Assessment of Healing of Thin or Perforated Cornea Treated by Amniotic Membrane Graft and Platelet Rich Plasma Clot
- ClinicalTrials.gov ID
- NCT06422897
- Acronym / sponsor ID
- OCT / 1133/04/2024
- Conditions
- Corneal Perforation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 13 participants (actual)
- Lead sponsor
- Minia UniversityUniversity, hospital or other
- Study start
- 15 Apr 2024 (actual)
- Primary completion
- 30 May 2024 (actual)
- Study completion
- 5 Jun 2024 (actual)
- First posted
- 21 May 2024 (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.
Assessment of healing of thin and perforated cornea after surgical treatment by anterior segment optical coherence tomography
Detailed description
- thin and perforated cornea (small perforation) is surgically treated by amniotic membrane graft and platelet rich plasma clot
- anterior segment optical coherence tomography is performed preoperative and 1 month postoperative to assess healing
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| cases after surgical management | – | Other: anterior segment optical coherence tomographycases are assessed by Anterior segment optical coherence tomography 1 month after surgical managemnt |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients from both sexes was thin cornea or small corneal perforation surgically treated by amniotic membrane graft and platelet rich plasma clot
Key inclusion criteria (2 listed)
- thin cornea about to perforate
- small corneal perforation
Key exclusion criteria (1 listed)
- active infection
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 |
|---|---|---|
| anterior segment optical coherence tomographysurgically treated corneal perforation by amniotic membrane graft and platelet rich plasma clot is assessed by anterior segment optical coherence tomography 1 month postoperative | Other | cases after surgical management |
Primary outcome
Depth of corneal healing measured by optical coherence tomography
Time frame: 1 month
complete corneal healing by anterior segment optical coherence tomography
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 23 Jul 2024.
- Results publication: PubMed 34623187Abdelghany AA, Bahrawy ME, Alio JL. Combined Platelet Rich Plasma and Amniotic membrane in the treatment of Perforated Corneal Ulcers. Eur J Ophthalmol. 2022 Jul;32(4):2148-2152. doi: 10.1177/11206721211049100. Epub 2021 Oct 8.
- Derived from this study: PubMed 41327137Khalafallah AM, Abdelghany AA, Alio JL, Abdelmonem AA, Mahmoud MSE. Role of AS-OCT in assessment of healing of thin or perforated cornea treated by amniotic membrane graft and PRP clot. BMC Ophthalmol. 2025 Dec 1;25(1):688. doi: 10.1186/s12886-025-04495-w.
- Individual participant dataSharing planned: Undecided
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, professor principal investigator
professor
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of 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 2 inclusion and 1 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 23 Jul 2024. 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?
Depth of corneal healing measured by optical coherence tomography (time frame: 1 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06422897, which also lists 2 linked publications.
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 23 Jul 2024.