Pediatric Ocular TraumaNCT05538260
Pediatric Ocular Trauma in Minia Governate
A study testing Repair of ocular trauma in children below 16 years old in people with Pediatric Ocular Trauma, run by Minia University at 1 site in Egypt.
Trial summary
The most common cause of unilateral blindness in pediatric age groups, especially in developing countries, is ocular trauma. The epidemiology of eye injuries varies in different parts of the world and different age groups and depends on many factors including life style, socioeconomic status, traffic state, sport and… Read more about this study
- Who is it for?
- Ages Up to 16 years
- Conditions the study is for
- Pediatric Ocular Trauma
- What is being tested?
- Repair of ocular trauma in children below 16 years old
- Type of treatment
- Surgery or procedure
- How many people
- 103 participants
- Where
- 1 siteEgypt
- Study dates
- 15 May 2017to 30 Jun 2023
- 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 Up to 16 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Age below 16 years
Who cannot join
- Age above 16 years Previous ocular surgery
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Minia University Hospital
Minya, Minya Governorate, 61111
Hosny A Zein, 01014145780, hosnyzein@yahoo.com
About this study
Official title: Epidemiology and Visual Outcome of Pediatric Ocular Trauma
The most common cause of unilateral blindness in pediatric age groups, especially in developing countries, is ocular trauma. The epidemiology of eye injuries varies in different parts of the world and different age groups and depends on many factors including life style, socioeconomic status, traffic state, sport and creative activities and type of registration and recording of data. About half a million people in the world are blind as a result of eye injuries. About 30-40% of monocular blindness is due to ocular trauma
- Conditions
- Pediatric Ocular Trauma
- Being tested
- Repair of ocular trauma in children below 16 years old
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Repair of ocular trauma in children below 16 years oldProcedure or surgery
Diagnosis and repair of pediatric ocular trauma
What is being measured
The primary outcome is the main question the study is designed to answer.
Epidemiology of trauma
incidence of trauma
Measured: 2 years
Visual outcome
Visual acuity
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Sep 2022
- Study start15 May 2017
- Primary completion20 May 2023 (estimated)
- Study completion30 Jun 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pediatric Ocular TraumaStudies 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
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 103 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Minia University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hosny Ahmed Zein, Minia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05538260
- Sponsor's protocol ID
- MiniaU PED
- Status last verified
- Sep 2022
- First submitted
- 8 Sep 2022
- Last updated
- 13 Sep 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Epidemiology and Visual Outcome of Pediatric Ocular Trauma
- ClinicalTrials.gov ID
- NCT05538260
- Acronym / sponsor ID
- MiniaU PED
- Conditions
- Pediatric Ocular Trauma
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 103 participants (estimated)
- Lead sponsor
- Minia UniversityUniversity, hospital or other
- Study start
- 15 May 2017 (actual)
- Primary completion
- 20 May 2023 (estimated)
- Study completion
- 30 Jun 2023 (estimated)
- First posted
- 13 Sep 2022 (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.
The most common cause of unilateral blindness in pediatric age groups, especially in developing countries, is ocular trauma. The epidemiology of eye injuries varies in different parts of the world and different age groups and depends on many factors including life style, socioeconomic status, traffic state, sport and creative activities and type of registration and recording of data. About half a million people in the world are blind as a result of eye injuries. About 30-40% of monocular blindness is due to ocular trauma
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- Up to 16 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Age below 16 years
Key exclusion criteria (1 listed)
- Age above 16 years Previous ocular surgery
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 |
|---|---|---|
| Repair of ocular trauma in children below 16 years oldDiagnosis and repair of pediatric ocular trauma | Procedure or surgery | – |
Primary outcome
Epidemiology of trauma
Time frame: 2 years
incidence of trauma
Visual outcome
Time frame: 6 months
Visual acuity
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Sep 2022.
- Individual participant dataSharing planned: No
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Repair of ocular trauma in children below 16 years old in people with Pediatric Ocular Trauma, 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 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 13 Sep 2022. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Hosny A Zein, MD (01014145780 ext. 02, hosnyzein@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Epidemiology of trauma (time frame: 2 years). The study lists 2 primary outcomes in all. 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 13 Sep 2022.