- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04521283
Visual Outcome of Traumatic Posterior Segment Complications
Visual Outcome of Traumatic Posterior Segment Complications in Upper Egypt :Tertiary Center Study
Study Overview
Status
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
Enrollment (Anticipated)
Contacts and Locations
Study Contact
- Name: Rehab M Azzam
- Phone Number: +201060391518
- Email: rehabazzam14111994@gmail.com
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- ADULT
- OLDER_ADULT
- CHILD
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
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
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
Sponsor
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
Study Major Dates
Study Start (ANTICIPATED)
Primary Completion (ANTICIPATED)
Study Completion (ANTICIPATED)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- traumatic posterior segment
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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