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Eye InjuriesNCT04521283

Visual Outcome of Traumatic Posterior Segment Complications

An observational study of Eye Injuries, run by Assiut University.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Any age
Conditions the study is for
Eye Injuries
How many people
60 participants
Where
No sites listed yet
Study dates
1 Oct 2020to 1 Aug 2021
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Any age
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Study population: Patients who underwent traumatic posterior segment complications of the eye

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

No sites are listed yet.

About this study

Official title: 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.

Read the 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)

Conditions
Eye Injuries
Medical subject headings
Eye Injuries

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Visual outcome of traumatic vitreous haemorrhage

    • The initial and final visual acuity outcomes will be compared to identify subjects who witnessed any improvement in their visual acuity

    Measured: One year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Aug 2020
  2. Study start1 Oct 2020 (estimated)
  3. Primary completion1 Aug 2021 (estimated)
  4. Study completion1 Aug 2021 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
60 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04521283
Sponsor's protocol ID
traumatic posterior segment
Status last verified
Sep 2020
First submitted
18 Aug 2020
Last updated
16 Sep 2020
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

An observational study of Eye Injuries, run by Assiut University.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 16 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Rehab M Azzam (+201060391518, rehabazzam14111994@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Visual outcome of traumatic vitreous haemorrhage (time frame: One year). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Sep 2020.

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