Playtime Open Globe Injuries in Children | NCT04497896

Studies
Playtime Open Globe Injuries in Children

NCT04497896

Sponsor

Assiut University

Status

Completed

Last Update Posted

Jul 28, 2021Actual

Enrollment

81Actual

Phase

Not provided

Conditions

Eye Trauma

Interventions

Repair of open globe injury

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2021

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 1, 2016Actual

Primary Completion Date

Jul 31, 2016Actual

Completion Date

Jan 1, 2017Actual

First Submitted Date

Jul 30, 2020

First Submission Date that Met QC Criteria

Jul 30, 2020

First Posted Date

Aug 4, 2020Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 22, 2021

Last Update Posted Date

Jul 28, 2021Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

This study investigated the epidemiology, aetiologies, and complications of playtime open-globe injuries in children at the Assiut University Hospital, Egypt, between January to July 2016.

Detailed Description

This prospective study was conducted at the Department of Ophthalmology, Assiut University Hospital, which is the largest tertiary referral hospital in Upper Egypt and provides 24-hour ophthalmic emergency services for six governorates. The study included all children (age ≤18 years) admitted with open-globe injuries that occurred during playtime over a 6-month study period. Demographic information (age and sex), the site and mechanism of injury, the site of ocular laceration (corneal, scleral or corneoscleral) and associated complications were recorded and analysed.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

81Actual

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Repair of open globe injury	Other	repair of corneal, corneoscleral, or scleral wounds

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Visual acuity (in Decimal using Snellen chart) after repair of open globe injury	measurement of corrected distant visual acuity after wound repair.	1 day

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

all children (age ≤18 years) admitted with open-globe injuries that occurred during playtime over a 6-month study period (January-July 2016).

Exclusion Criteria:

Open globe injuries in patients olader than 18 years.
Closed globe injuries

Accepts Healthy Volunteers

Not provided

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

18 Years

Standard Ages

ChildAdult

Study Population

all children (age ≤18 years) admitted to Assiut university hospital with open-globe injuries that occurred during playtime over a 6-month study period (January-July 2016).

Sampling Method

Probability Sample

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D005131	Eye Injuries

Ancestor Terms

ID	Term
D005151	Facial Injuries
D006259	Craniocerebral Trauma
D020196	Trauma, Nervous System
D009422	Nervous System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided