NCT04595357

Brief Summary

Intraocular foreign body (IOFB) injury is a common potentially serious form of ocular trauma. Metallic IOFB is the most common type of IOFB injury. Apart from the associated ocular tissue damage, Metallic IOFB may cause permanent visual impairment due to retinal toxicity and endophthalmitis. When presenting posteriorly, the approach of IOFB removal is challenging. Several techniques had been described for posterior IOFB removal. All of these techniques aimed to remove IOFB with the least possible collateral damage. This study aims to describe "Iris shelf" technique for posterior IOFB removal through a clear corneal incision combined with phaco-vitrectomy and report its outcomes.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
33

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jan 2016

Longer than P75 for all trials

Status
completed

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

Study Start

First participant enrolled

January 1, 2016

Completed
4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2019

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2020

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

October 14, 2020

Completed
6 days until next milestone

First Posted

Study publicly available on registry

October 20, 2020

Completed
Last Updated

October 20, 2020

Status Verified

October 1, 2020

Enrollment Period

4 years

First QC Date

October 14, 2020

Last Update Submit

October 14, 2020

Conditions

Outcome Measures

Primary Outcomes (1)

  • corrected distance visual acuity

    1 month

Interventions

Removal of posterior segment intraocular foreign bodies through corneal incision combined with phaco-vitrectomy

Eligibility Criteria

Age15 Years - 45 Years
Sexall
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

patients with posterior segment metallic IOFB who underwent combined phacovitrectomy with IOFB removal through a clear corneal incision using "Iris shelf" technique at Assiut University hospitals and Al-Forsan eye center, Assiut; Egypt in the period between January 2016 and December 2019.

You may qualify if:

  • \- posterior segment metallic IOFB who underwent combined phacovitrectomy with IOFB removal through a clear corneal incision using "Iris shelf" technique

You may not qualify if:

  • Any other surgical technique for posterior segment IOFB removal

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 Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate professor of Ophthalmology

Study Record Dates

First Submitted

October 14, 2020

First Posted

October 20, 2020

Study Start

January 1, 2016

Primary Completion

December 31, 2019

Study Completion

July 1, 2020

Last Updated

October 20, 2020

Record last verified: 2020-10

Data Sharing

IPD Sharing
Will not share