Pediatric Ocular Trauma in Minia Governate

• Sponsor: Minia University (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT05538260
• Collaborator: (none)
• Enrollment: 103
• Location: 1
• Anticipated Duration (Months): 73.5
• Patients Per Site Per Month: 1.4

Study Details

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

Condition or Disease	Intervention/Treatment	Phase
Pediatric Ocular Trauma	Procedure: Repair of ocular trauma in children below 16 years old	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 103 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Health Services Research
• Official Title: Epidemiology and Visual Outcome of Pediatric Ocular Trauma
• Actual Study Start Date: May 15, 2017
• Anticipated Primary Completion Date: May 20, 2023
• Anticipated Study Completion Date: Jun 30, 2023

Outcome Measures

Primary Outcome Measures

1. Epidemiology of trauma [2 years]

   incidence of trauma

2. Visual outcome [6 months]

   Visual acuity

Eligibility Criteria

Criteria

• Ages Eligible for Study: N/A to 16 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Age below 16 years

Exclusion Criteria:

• Age above 16 years Previous ocular surgery

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Minia University Hospital	Al Minyā	Minia	Egypt	61111

Sponsors and Collaborators

• Minia University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Hosny Ahmed Zein, DR, Minia University
• ClinicalTrials.gov Identifier: NCT05538260
• Other Study ID Numbers: MiniaU PED
• First Posted: Sep 13, 2022
• Last Update Posted: Sep 13, 2022
• Last Verified: Sep 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Wounds and Injuries

Study Results

No Results Posted as of Sep 13, 2022