NCT05663814

Brief Summary

: Detailed history should be taken from the patients ( age ,sex ,location of accident (rural or civil) , time of injury , mode of trauma, exact mechanism of injury ) Examination at baseline to determine location and extent of injury. Associated injuries e.g. cataract ,hyphema . Assessment for other life threatening injuries. Exclusion of IOFB. The presenting visual acuity should be recorded in injuried and uninjuried eye. Fundus examination if possible. The pupils should be examined for RAPD (in blunt trauma searching post traumatic optic neuropathy) Slit lamp examination at presentation to detect extent of damage. {type of wound ( corneal ,scleral ,or corneoscleral ) , prolapsed uveal tissue presence of hyphema ,sublaxated or dislocated lens ,prolapsed vitreous } Investigations done before repair (e.g. CT orbit ) Time of primary repair should be recorded. Follow up visits at 1 day, 1 week, 1 month, 3 months for :-

  1. 1.For healing.
  2. 2.Suture status.
  3. 3.Detailed slit lamp and fundus examination.
  4. 4.UCVA
  5. 5.BCVA
  6. 6.Investigations including:- B scan if hazy media OCT if clear media
  7. 7.Refraction if possible Post operative complications and 2ry interventions

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
50

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Dec 2023

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

November 19, 2022

Completed
1 month until next milestone

First Posted

Study publicly available on registry

December 23, 2022

Completed
11 months until next milestone

Study Start

First participant enrolled

December 1, 2023

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2024

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2024

Completed
Last Updated

December 23, 2022

Status Verified

December 1, 2022

Enrollment Period

10 months

First QC Date

November 19, 2022

Last Update Submit

December 15, 2022

Conditions

Outcome Measures

Primary Outcomes (1)

  • Factors affecting prognosis of open globe injuries in Assiut university hospitals

    Final visual acuity in Snellen chart

    1 year

Eligibility Criteria

Age6 Years+
Sexall
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Any patient more than 6 years presented with open globe injury

You may qualify if:

  • Age + 6
  • Laceration, incised injury ,Penetrating and perforating injuries
  • Rupture globe

You may not qualify if:

  • age less than 6
  • patients unwilling to participate in study
  • patients with disorganized globes

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Zhou Y, Chang P, Abdelmalik B, Mayer Z, Shah A, Steigleman WA. Prognosis of Open Globe Injuries at a Tertiary Referral Center: The Modified Florida Ocular Trauma Score. Am J Ophthalmol. 2022 Dec;244:152-165. doi: 10.1016/j.ajo.2022.08.015. Epub 2022 Aug 23.

    PMID: 36007553BACKGROUND

Study Officials

  • Kamel Soliman, Prof

    Assiut University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

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

Study Record Dates

First Submitted

November 19, 2022

First Posted

December 23, 2022

Study Start

December 1, 2023

Primary Completion

October 1, 2024

Study Completion

December 30, 2024

Last Updated

December 23, 2022

Record last verified: 2022-12