NCT04630509

Brief Summary

this study aims to explore the demography of pediatric traumatic cataract in upper Egypt, and report outcomes and complications of traumatic cataract surgery in these children.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
34

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jan 2019

Geographic Reach
1 country

1 active site

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, 2019

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2020

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2020

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

November 10, 2020

Completed
6 days until next milestone

First Posted

Study publicly available on registry

November 16, 2020

Completed
Last Updated

November 16, 2020

Status Verified

November 1, 2020

Enrollment Period

1.5 years

First QC Date

November 10, 2020

Last Update Submit

November 13, 2020

Conditions

Traumatic Cataract

Keywords

pediatric ocular traumaPosterior chamber intraocular lens

Outcome Measures

Primary Outcomes (3)

  • Demographics

    Age(in years), and gender (male or female) procedure, visual outcome, postoperative complications

    6 months

  • Mechanism of injury

    Blunt or penetrating eye injury

    6 months

  • Visual outcome

    Visual acuity according to Snellen chart and LogMAR

    6 months

Interventions

traumatic cataract extractionPROCEDURE

Irrigation/aspiration of traumatic cataract in children with posterior chamber intraocular lens implantation

Eligibility Criteria

AgeUp to 17 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

All children admitted for traumatic cataract surgery at Assiut university hospital

You may qualify if:

  • All children who have undergone traumatic cataract surgery at Assiut university over 1 year period.

You may not qualify if:

  • children with posterior segment injury.
  • children who did not complete at least 6 months of postoperative follow-up.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Assiut university hospital

Asyut, Egypt

Location

Related Publications (1)

  • Kedwany SM, Saleh MGA, Tohamy D, Mostafa MM. Outcome of Pediatric Traumatic Cataract in Upper Egypt: A Tertiary Center Study. Clin Ophthalmol. 2021 Apr 16;15:1583-1589. doi: 10.2147/OPTH.S282080. eCollection 2021.

    PMID: 33888974DERIVED

Study Officials

  • Salma Kedwany, MD

    Assiut University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer of Ophthalmology

Study Record Dates

First Submitted

November 10, 2020

First Posted

November 16, 2020

Study Start

January 1, 2019

Primary Completion

June 30, 2020

Study Completion

August 31, 2020

Last Updated

November 16, 2020

Record last verified: 2020-11

Data Sharing

IPD Sharing
Will not share

to report the demographics and outcomes of pediatric traumatic cataract in upper Egypt

Locations

EG(1)