Back to resultsPediatric Ocular Trauma in Minia Governate
Primary Purpose
Pediatric Ocular Trauma
Status
Recruiting
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Repair of ocular trauma in children below 16 years old
Sponsored by
About this trial
This is an interventional health services research trial for Pediatric Ocular Trauma
Eligibility Criteria
Inclusion Criteria:
- Age below 16 years
Exclusion Criteria:
- Age above 16 years Previous ocular surgery
Sites / Locations
- Minia University HospitalRecruiting
Outcomes
Primary Outcome Measures
Epidemiology of trauma
incidence of trauma
Visual outcome
Visual acuity
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05538260
Brief Title
Pediatric Ocular Trauma in Minia Governate
Official Title
Epidemiology and Visual Outcome of Pediatric Ocular Trauma
Study Type
Interventional
2. Study Status
Record Verification Date
September 2022
Overall Recruitment Status
Recruiting
Study Start Date
May 15, 2017 (Actual)
Primary Completion Date
May 20, 2023 (Anticipated)
Study Completion Date
June 30, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Minia University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief 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 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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pediatric Ocular Trauma
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
103 (Anticipated)
8. Arms, Groups, and Interventions
Intervention Type
Procedure
Intervention Name(s)
Repair of ocular trauma in children below 16 years old
Intervention Description
Diagnosis and repair of pediatric ocular trauma
Primary Outcome Measure Information:
Title
Epidemiology of trauma
Description
incidence of trauma
Time Frame
2 years
Title
Visual outcome
Description
Visual acuity
Time Frame
6 months
10. Eligibility
Sex
All
Maximum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Age below 16 years
Exclusion Criteria:
Age above 16 years Previous ocular surgery
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Hosny A Zein, MD
Phone
01014145780
Ext
02
Email
hosnyzein@yahoo.com
Facility Information:
Facility Name
Minia University Hospital
City
Al Minyā
State/Province
Minia
ZIP/Postal Code
61111
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hosny A Zein
Phone
01014145780
Email
hosnyzein@yahoo.com
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Pediatric Ocular Trauma in Minia Governate
We'll reach out to this number within 24 hrs