EndophthalmitisNCT06673784
Evaluation and Risk Factors of Post-traumatic Endophthalmitis
An observational study of Endophthalmitis, run by Assiut University.
Trial summary
1. identify the incidence of post-traumatic endophthalmitis and the related risk factors influencing its development. 2. study the clinical- microbiological profile and evaluate the functional and anatomical outcomes of post-traumatic endophthalmitis (PPTE). Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Endophthalmitis
- What is being tested?
- ophthalmic saline eye drops and Saline
- How many people
- 41 participants
- Where
- No sites listed yet
- Study dates
- 10 Nov 2024to Mar 2026
- 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 Any age
- All sexes
- Child, Adult, Older adult
Study population: Evaluation and risk factors of post-traumatic endophthalmitis with general and optical examination on patients exposed to eye trauma and developed post-traumatic endophthalmitis
Who may be able to join
- Patients exposed to eye trauma and developed post-traumatic endophthalmitis
Who cannot join
- Patients who refuse to sign informed consent in this study
Trial locations and contacts
No sites are listed yet.
About this study
- identify the incidence of post-traumatic endophthalmitis and the related risk factors influencing its development.
- study the clinical- microbiological profile and evaluate the functional and anatomical outcomes of post-traumatic endophthalmitis (PPTE).
- Conditions
- Endophthalmitis
- Being tested
- ophthalmic saline eye drops, Saline
- Medical subject headings
- Endophthalmitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ophthalmic saline eye dropsDiagnostic test
for optical examination
SalineDrug
Most one natural and not effects on study
| Study group | Role | What they receive |
|---|---|---|
| Evaluation of post-traumatic endophthalmitis | 1. conception
2. acquisition of data
3. analysis of data Receives: Diagnostic Test: ophthalmic saline eye drops; Drug: Saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Knowledge of clinical features outcomes of post-traumatic endophthalmitis
Knowledge of clinical features which will be shown due to post-traumatic endophthalmitis
Measured: Baseline
Secondary outcomes (1)
The factors associated with a worse prognosis in post-traumatic endophthalmitis
Discrimination the worst prognosis in post-traumatic endophthalmitis
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Nov 2024
- Study start10 Nov 2024 (estimated)
- Primary completion28 Feb 2026 (estimated)
- Study completionMar 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for EndophthalmitisStudies of the same condition, open and under way.
- More trials run by Assiut 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 41 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hadeer Gamal AbdElmohsen Ahmed, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06673784
- Sponsor's protocol ID
- Ev. of post-traumatic Endoph.
- Status last verified
- Oct 2024
- First submitted
- 31 Oct 2024
- Last updated
- 5 Nov 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
Alfaro DV, Roth DB, Laughlin RM, Goyal M, Liggett PE. Paediatric post-traumatic endophthalmitis. Br J Ophthalmol. 1995 Oct;79(10):888-91. doi: 10.1136/bjo.79.10.888.
PubMed 7488575
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation and Risk Factors of Post-traumatic Endophthalmitis
- ClinicalTrials.gov ID
- NCT06673784
- Acronym / sponsor ID
- Ev. of post-traumatic Endoph.
- Conditions
- Endophthalmitis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 41 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 10 Nov 2024 (estimated)
- Primary completion
- 28 Feb 2026 (estimated)
- Study completion
- Mar 2026 (estimated)
- First posted
- 5 Nov 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.
- identify the incidence of post-traumatic endophthalmitis and the related risk factors influencing its development.
- study the clinical- microbiological profile and evaluate the functional and anatomical outcomes of post-traumatic endophthalmitis (PPTE).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Evaluation of post-traumatic endophthalmitis | – | Diagnostic Test: ophthalmic saline eye drops, Drug: Saline1. conception 2. acquisition of data 3. analysis of data |
Who may qualify
- Sex
- All
- Age groups
- Child, Adult, Older adult
- Study population
- Evaluation and risk factors of post-traumatic endophthalmitis with general and optical examination on patients exposed to eye trauma and developed post-traumatic endophthalmitis
Key inclusion criteria (1 listed)
- Patients exposed to eye trauma and developed post-traumatic endophthalmitis
Key exclusion criteria (1 listed)
- Patients who refuse to sign informed consent in this study
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 |
|---|---|---|
| ophthalmic saline eye dropsfor optical examination | Diagnostic test | Evaluation of post-traumatic endophthalmitis |
| SalineMost one natural and not effects on study | Drug | Evaluation of post-traumatic endophthalmitis |
Primary outcome
Knowledge of clinical features outcomes of post-traumatic endophthalmitis
Time frame: Baseline
Knowledge of clinical features which will be shown due to post-traumatic endophthalmitis
1 secondary outcome
The factors associated with a worse prognosis in post-traumatic endophthalmitis
Time frame: Baseline
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Nov 2024.
- Results publication: PubMed 7488575Alfaro DV, Roth DB, Laughlin RM, Goyal M, Liggett PE. Paediatric post-traumatic endophthalmitis. Br J Ophthalmol. 1995 Oct;79(10):888-91. doi: 10.1136/bjo.79.10.888.
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of Endophthalmitis, run by Assiut University.
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 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: status not confirmed, as of the sponsor's last update on 5 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Hadeer Gamal AbdElmohsen, 3 (00201091593658 ext. 01147084398, hadeergamal294@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Knowledge of clinical features outcomes of post-traumatic endophthalmitis (time frame: Baseline). 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 NCT06673784, which also lists 1 linked publication.
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 5 Nov 2024.