NCT04497896

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
81

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2016

Shorter than P25 for all trials

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2016

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2016

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2017

Completed
3.6 years until next milestone

First Submitted

Initial submission to the registry

July 30, 2020

Completed
5 days until next milestone

First Posted

Study publicly available on registry

August 4, 2020

Completed
Last Updated

July 28, 2021

Status Verified

July 1, 2021

Enrollment Period

7 months

First QC Date

July 30, 2020

Last Update Submit

July 22, 2021

Conditions

Eye Trauma

Outcome Measures

Primary Outcomes (1)

  • Visual acuity (in Decimal using Snellen chart) after repair of open globe injury

    measurement of corrected distant visual acuity after wound repair.

    1 day

Interventions

Repair of open globe injuryOTHER

repair of corneal, corneoscleral, or scleral wounds

Eligibility Criteria

AgeUp to 18 Years
Sexall
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodProbability Sample
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).

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Eye Injuries

Condition Hierarchy (Ancestors)

Facial InjuriesCraniocerebral TraumaTrauma, Nervous SystemNervous System DiseasesEye DiseasesWounds and Injuries

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate professor of Ophthalmology

Study Record Dates

First Submitted

July 30, 2020

First Posted

August 4, 2020

Study Start

January 1, 2016

Primary Completion

July 31, 2016

Study Completion

January 1, 2017

Last Updated

July 28, 2021

Record last verified: 2021-07

Data Sharing

IPD Sharing
Will not share