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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04630509
Other study ID # Pediatric traumatic cataract
Secondary ID
Status Completed
Phase
First received
Last updated
Start date January 1, 2019
Est. completion date August 31, 2020

Study information

Verified date November 2020
Source Assiut University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 34
Est. completion date August 31, 2020
Est. primary completion date June 30, 2020
Accepts healthy volunteers No
Gender All
Age group N/A to 17 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
Egypt Assiut university hospital Assiut

Sponsors (1)

Lead Sponsor Collaborator
Assiut University

Country where clinical trial is conducted

Egypt, 

Outcome

Type Measure Description Time frame Safety issue
Primary Demographics Age(in years), and gender (male or female) procedure, visual outcome, postoperative complications 6 months
Primary Mechanism of injury Blunt or penetrating eye injury 6 months
Primary Visual outcome Visual acuity according to Snellen chart and LogMAR 6 months
See also
  Status Clinical Trial Phase
Completed NCT02900365 - Early Vs Late Post Traumatic Cataract Surgery N/A
Recruiting NCT03063216 - Shanghai Pediatric Cataract Study