IOFB: Extraction Routes of Intraocular Foreign Body

Sponsor
Zagazig University (Other)
Overall Status
Recruiting
CT.gov ID
NCT05966545
Collaborator
(none)
48
1
2
20.9
2.3

Study Details

Study Description

Brief Summary

Intra ocular foreign body removal is indicated to avoid further many complications such as retinal detachment, endophthalmitis. The surgical approach for a posterior segment IOFB is pars plana vitrectomy and its extraction either through the pars plana. our study is to compare limbal route versus pars plana route for extraction of posterior segment IOFB associated with cataract as regard to safety and complications.

Condition or Disease Intervention/Treatment Phase
  • Procedure: pars plana vitrectomy and intraocular foreign body removal
N/A

Detailed Description

Penetrating ocular injuries with retained posterior segment intraocular foreign body (IOFB) are relatively common and account for 17% to 41% of ocular injuries.

Intra ocular foreign body removal is indicated to avoid further many complications such as retinal detachment, endophthalmitis, retinal toxicity (secondary to chalcosis, siderosis) and sympathetic ophthalmia.

The surgical approach for a posterior segment IOFB is pars plana vitrectomy (PPV) and its extraction either through the pars plana or the limbus.

PPV and IOFB extraction through sclerotomy is the most commonly used approach. Most commonly retained posterior segment intra ocular foreign bodies (IOFB) are removed after enlarging one of the sclerotomy ports during pars plana vitrectomy. Intra operative complications reported during IOFB extraction were hypotony, vitreous hemorrhage, incarceration of the retina in the wound, IOFB slippage. Reported post-operative complications were glaucoma and retinal detachment. Incidence of post-operative RD was reported to range from 22% to 79% with poor visual outcomes in most cases PPV and IOFB extraction through the limbal route is an alternative approach to remove IOFB. Complications reported were less frequent and include microscopic hyphema and vitreous hemorrhage. The incidence of post-operative retinal detachment after IOFB extraction through limbus was reported to range from 7.15% to 27.7 % The limbal route for retained posterior segment IOFB extraction can offer the following advantages: it allows visually controlled delivery of the IOFB from the posterior pole to the limbal exit and it has no relation to the vitreous base, thus minimizing the risk of creating a peripheral retinal break during extraction of intraocular foreign body, in contrast to the hidden part behind the iris when using the pars plana route.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
48 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Participant)
Primary Purpose:
Treatment
Official Title:
Outcomes of Retained Posterior Segment Intraocular Foreign Body Extraction With Coexisting Cataract Via The Limbus or The Pars Plana Route
Actual Study Start Date :
Jan 1, 2022
Anticipated Primary Completion Date :
Aug 30, 2023
Anticipated Study Completion Date :
Sep 30, 2023

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: intraocular foreign body extraction via the limbus

pars plana vitrectomy and intraocular foreign body removal via the limbus, after complete removal of adhesions around intraocular foreign body, then the foreign body will be grasped using basket forceps, and it will be brought to anterior chamber and then removed through limbal incision. The external earth magnet will be applied close to the limbus to prevent its slippage from the forceps if needed.

Procedure: pars plana vitrectomy and intraocular foreign body removal
removal of vitreous body and attachment to foreign body then extraction of foreign body

Active Comparator: intraocular foreign body extraction via the pars plana route

pars plana vitrectomy and intraocular foreign body removal via pars plana route, after complete removal of adhesions around intraocular foreign body, then IOFB will be grasped using basket forceps, and while the IOFB removed through the sclerotomy an external earth magnet will be applied close to the sclerotomy after enlargement the sclerotomy to prevent its slippage from the forceps and falling down onto the posterior pole if needed.

Procedure: pars plana vitrectomy and intraocular foreign body removal
removal of vitreous body and attachment to foreign body then extraction of foreign body

Outcome Measures

Primary Outcome Measures

  1. post-operative retinal detachment [1, 3 and 6 months]

    comparing incidence of post-operative retinal detachment after intraocular foreign body extraction via limbus versus pars plana route.

Secondary Outcome Measures

  1. post-operative best corrected visual acuity [1, 3 and 6 months]

    report post-operative best corrected visual acuity after intraocular foreign body extraction via limbus versus pars plana route.

  2. associated intra operative and post-operative complications. [1, 3 and 6 months]

    report associated intra operative and post-operative complications

Eligibility Criteria

Criteria

Ages Eligible for Study:
N/A and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:
  • Eyes with retained posterior segment intraocular foreign body associated with crystalline lens injury.

  • Eyes with retained posterior segment intraocular foreign body associated with coexisting cataract.

Exclusion Criteria:
  • Eyes with pre-operative retinal detachment

  • Eyes with retained posterior segment IOFB with clear lens.

  • Anterior segment IOFBs

  • Severely damaged eyes with an initial visual acuity of no light perception where enucleation is the primary treatment

  • Patients with severely traumatized cornea which can affect visualization during vitrectomy.

  • Pseudophakic eyes.

  • Eyes with endophthalmitis

Contacts and Locations

Locations

Site City State Country Postal Code
1 faculty of medicine, Zagazig university Zagazig Sharkia Egypt 44511

Sponsors and Collaborators

  • Zagazig University

Investigators

  • Study Director: sherif A. Dabour, MD, Zagazig University
  • Study Director: Ahmad S. Khalil, MD, Zagazig University

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Abbas Abomesslam Ali Hashem, assistant lecturer, Zagazig University
ClinicalTrials.gov Identifier:
NCT05966545
Other Study ID Numbers:
  • ZU-IRB#9040/24-10-24
First Posted:
Jul 28, 2023
Last Update Posted:
Jul 28, 2023
Last Verified:
Jul 1, 2023
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jul 28, 2023