NCT04521283

Brief 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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Oct 2020

Shorter than P25 for all trials

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 18, 2020

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 20, 2020

Completed
1 month until next milestone

Study Start

First participant enrolled

October 1, 2020

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2021

Completed
Last Updated

September 16, 2020

Status Verified

September 1, 2020

Enrollment Period

10 months

First QC Date

August 18, 2020

Last Update Submit

September 13, 2020

Conditions

Eye Injuries

Outcome Measures

Primary Outcomes (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

    One year

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients who underwent traumatic posterior segment complications of the eye

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Eye Injuries

Condition Hierarchy (Ancestors)

Facial InjuriesCraniocerebral TraumaTrauma, Nervous SystemNervous System DiseasesEye DiseasesWounds and Injuries

Study Officials

  • Samir Y Salah, Professor

    Assiut University

    STUDY DIRECTOR

  • Abdelsalam Abdallah, Professor

    Assiut University

    STUDY DIRECTOR

  • Dalia M Eltohamy, Lecturer

    Assiut University

    STUDY DIRECTOR

Central Study Contacts

Rehab M Azzam

CONTACT

+201060391518rehabazzam14111994@gmail.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principle investigator

Study Record Dates

First Submitted

August 18, 2020

First Posted

August 20, 2020

Study Start

October 1, 2020

Primary Completion

August 1, 2021

Study Completion

August 1, 2021

Last Updated

September 16, 2020

Record last verified: 2020-09