Epidemiology and Outcome of Pediatric Traumatic Cataract

November 13, 2020 updated by: Salma Mohamed M. A. Kedwany, Assiut University

Epidemiology and Outcomes of Pediatric Traumatic Cataract in Upper Egypt: A Tertiary Center Study

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Ocular trauma is one of the leading causes of acquired unilateral blindness in childhood.1,2 Apart from the permanent disability, ocular trauma has a profound impact on both patients and society at different levels, including, but not limited to, psychological trauma, cosmetic disfigurement, socioeconomic costs, and the need for specialized medical care and vocational rehabilitation.

Traumatic cataract is a common complication of pediatric eye injury. In developing countries, ocular trauma was responsible for up to 45% of childhood cataract. Vision loss induced by traumatic cataract is surgically manageable. However, the high risk of postoperative inflammation, posterior capsular opacification (PCO), amblyopia, and the associated ocular tissue damage may negatively impact visual outcome.

Several studies reported visual outcome of pediatric traumatic cataract in different populations. With the sacristy of studies on traumatic cataract in Egyptian children, we conducted this retrospective study to report the demographic features, visual outcome, and complications of pediatric traumatic cataract at Assiut University Hospital, the biggest tertiary referral center in Upper Egypt.

Study Type

Observational

Enrollment (Actual)

34

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Assiut, Egypt
        • Assiut University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 17 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

All children admitted for traumatic cataract surgery at Assiut university hospital

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Only
  • Time Perspectives: Retrospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Demographics
Time Frame: 6 months
Age(in years), and gender (male or female) procedure, visual outcome, postoperative complications
6 months
Mechanism of injury
Time Frame: 6 months
Blunt or penetrating eye injury
6 months
Visual outcome
Time Frame: 6 months
Visual acuity according to Snellen chart and LogMAR
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assiut University

Investigators

  • Principal Investigator: Salma Kedwany, MD, Assiut University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2019

Primary Completion (Actual)

June 30, 2020

Study Completion (Actual)

August 31, 2020

Study Registration Dates

First Submitted

November 10, 2020

First Submitted That Met QC Criteria

November 13, 2020

First Posted (Actual)

November 16, 2020

Study Record Updates

Last Update Posted (Actual)

November 16, 2020

Last Update Submitted That Met QC Criteria

November 13, 2020

Last Verified

November 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Pediatric traumatic cataract

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

IPD Plan Description

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

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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