Visual Outcome of Traumatic Posterior Segment Complications

September 13, 2020 updated by: Rehab Azzam, Assiut University

Visual Outcome of Traumatic Posterior Segment Complications in Upper Egypt :Tertiary Center Study

to identify the demographic, the clinical characteristics and the possible predictive factors affecting long-term visual outcomes of traumatic posterior segment complications presenting to Assiut University Hospital.

Study Overview

Status

Unknown

Conditions

Detailed Description

Ocular trauma is an important public health problem which is preventable and its etiology, severity, and outcome depends on many factors in the changing environment . Even eyes represent only 0.27% of the body surface area and 4% of the facial area, they are the third most commonly trauma-exposed area after the hands and feet . It is estimated that, worldwide, there are approximately 1.6 million people blind from eye injuries, 2.3 million bilaterally visually impaired and 19 million with unilateral visual loss; these facts make ocular trauma the most common cause of unilateral blindness . In population-based surveys, the percentage of monocular blindness due to trauma ranged from 20% to 50% and of bilateral blindness from 3.2% to 5.5% .

Ocular injuries vary with a broad range of severity and include simple subconjunctival injury, lid laceration, corneal abrasion, traumatic iritis, hyphaema, lens injury, vitreous haemorrhage (VH) , retinal detachment, traumatic optic neuropathy, retrobulbar haemorrhage, orbital fracture, and ruptured globes. Ocular injuries are classified into 2 groups as open and close globe injuries. Ruptured globes fall into the category of open globe injuries, which are injuries resulting in a full-thickness laceration of the cornea and/or sclera. Wounds can be penetrating (with one entry wound and no exit wound), or perforating (a through-and-through injury with both entrance and exit wounds) . Closed globe injuries resulting from blunt trauma can cause hyphaema, vitreous haemorrhage, retinal tears and detachment, choroidal rupture, macular oedema, and even globe rupture, retrobulbar haemorrhage and traumatic optic neuropathy .

In Kasr El Aini Hospital The majority of ocular trauma in their population was due to assaultive injuries occurring mainly in males. Open globe injuries were more common than closed globe injuries, and globe lacerations were more common than ruptured globes .

IN Upper Egypt Pediatric ocular trauma among patients referred to their tertiary ophthalmology referral center over a period of 1 year was 3.7%. Of these, 67.3% of cases had open globe injury, 30.7% had closed injury, and only 2% had chemical injury.

Posterior segment ocular trauma is still an important cause of visual loss and disability in working-age population. With modern surgical approaches, many eyes can be salvaged with retention of vision(9). These complications are retinal detachment (RD), vitreous hemorrhage(VH), posterior intraocular foreign body (IOFB), dislo-cated lens, choroidal detachment(10)

Study Type

Observational

Enrollment (Anticipated)

60

Contacts and Locations

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

Study Contact

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

  • ADULT
  • OLDER_ADULT
  • CHILD

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients who underwent traumatic posterior segment complications of the eye

Description

Inclusion Criteria:

All patients presenting with traumatic posterior segment complications in outpatient clinics and operative rooms

Exclusion Criteria:

  • A history of recent intraocular surgery
  • No history of trauma.
  • Loss to 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Visual outcome of traumatic vitreous haemorrhage
Time Frame: One year
• The initial and final visual acuity outcomes will be compared to identify subjects who witnessed any improvement in their visual acuity
One year

Collaborators and Investigators

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

Investigators

  • Study Director: Samir Y Salah, Professor, Assiut University
  • Study Director: Abdelsalam Abdallah, Professor, Assiut University
  • Study Director: Dalia M Eltohamy, Lecturer, Assiut University

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 (ANTICIPATED)

October 1, 2020

Primary Completion (ANTICIPATED)

August 1, 2021

Study Completion (ANTICIPATED)

August 1, 2021

Study Registration Dates

First Submitted

August 18, 2020

First Submitted That Met QC Criteria

August 18, 2020

First Posted (ACTUAL)

August 20, 2020

Study Record Updates

Last Update Posted (ACTUAL)

September 16, 2020

Last Update Submitted That Met QC Criteria

September 13, 2020

Last Verified

September 1, 2020

More Information

Terms related to this study

Other Study ID Numbers

  • traumatic posterior segment

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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