Epidemiology and Outcome of Pediatric Traumatic Cataract

• Sponsor: Assiut University (Other)
• Overall Status: Completed
• CT.gov ID: NCT04630509
• Collaborator: (none)
• Enrollment: 34
• Location: 1
• Actual Duration (Months): 20
• Patients Per Site Per Month: 1.7

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Traumatic Cataract	Procedure: traumatic cataract extraction

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 Design

• Study Type: Observational
• Actual Enrollment: 34 participants
• Observational Model: Case-Only
• Time Perspective: Retrospective
• Official Title: Epidemiology and Outcomes of Pediatric Traumatic Cataract in Upper Egypt: A Tertiary Center Study
• Actual Study Start Date: Jan 1, 2019
• Actual Primary Completion Date: Jun 30, 2020
• Actual Study Completion Date: Aug 31, 2020

Outcome Measures

Primary Outcome Measures

1. Demographics [6 months]

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

2. Mechanism of injury [6 months]

   Blunt or penetrating eye injury

3. Visual outcome [6 months]

   Visual acuity according to Snellen chart and LogMAR

Eligibility Criteria

Criteria

• Ages Eligible for Study: N/A to 17 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Assiut university hospital	Assiut		Egypt

Sponsors and Collaborators

• Assiut University

Investigators

• Principal Investigator: Salma Kedwany, MD, Assiut University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Salma Mohamed M. A. Kedwany, Lecturer of Ophthalmology, Assiut University
• ClinicalTrials.gov Identifier: NCT04630509
• Other Study ID Numbers: Pediatric traumatic cataract
• First Posted: Nov 16, 2020
• Last Update Posted: Nov 16, 2020
• Last Verified: Nov 1, 2020

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Salma Mohamed M. A. Kedwany, Lecturer of Ophthalmology, Assiut University: pediatric ocular trauma; Posterior chamber intraocular lens
• Additional relevant MeSH terms: Cataract

Study Results

No Results Posted as of Nov 16, 2020