Extraction Routes of Intraocular Foreign Body (IOFB)

Outcomes of Retained Posterior Segment Intraocular Foreign Body Extraction With Coexisting Cataract Via The Limbus or The Pars Plana Route

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.

Study Overview

• Status: Recruiting
• Conditions: Intraocular Foreign Body
• Intervention / Treatment: Procedure: pars plana vitrectomy and intraocular foreign body removal

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 Type: Interventional
• Enrollment (Estimated): 48
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Abbas A. Ali Hashem, Msc; Phone Number: 002 01066227749; Email: aaahashem@medicine.zu.edu.eg
• Study Contact Backup: Name: Wael M. EL Haig, MD; Phone Number: 002 01222155744; Email: waelmohamed@medicine.zu.edu.eg

Study Locations

• Egypt
  • Sharkia
    • Zagazig, Sharkia, Egypt, 44511
      • Recruiting
      • Faculty of Medicine, Zagazig University
      • Contact: Abbas A. Ali Hashem, Msc; Phone Number: 002 01066227749; Email: aaahashem@medicine.zu.edu.eg
      • Contact: Wael M. EL Haig, MD; Phone Number: 002 01222155744; Email: waelmohamed@medicine.zu.edu.eg

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
post-operative retinal detachment	comparing incidence of post-operative retinal detachment after intraocular foreign body extraction via limbus versus pars plana route.	1, 3 and 6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
post-operative best corrected visual acuity	report post-operative best corrected visual acuity after intraocular foreign body extraction via limbus versus pars plana route.	1, 3 and 6 months
associated intra operative and post-operative complications.	report associated intra operative and post-operative complications	1, 3 and 6 months

Collaborators and Investigators

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

Publications and helpful links

General Publications

• Demircan N, Soylu M, Yagmur M, Akkaya H, Ozcan AA, Varinli I. Pars plana vitrectomy in ocular injury with intraocular foreign body. J Trauma. 2005 Nov;59(5):1216-8. doi: 10.1097/01.ta.0000196438.48182.ff.
• Loporchio D, Mukkamala L, Gorukanti K, Zarbin M, Langer P, Bhagat N. Intraocular foreign bodies: A review. Surv Ophthalmol. 2016 Sep-Oct;61(5):582-96. doi: 10.1016/j.survophthal.2016.03.005. Epub 2016 Mar 17.
• Wani VB, Al-Ajmi M, Thalib L, Azad RV, Abul M, Al-Ghanim M, Sabti K. Vitrectomy for posterior segment intraocular foreign bodies: visual results and prognostic factors. Retina. 2003 Oct;23(5):654-60. doi: 10.1097/00006982-200310000-00008.
• Wickham L, Xing W, Bunce C, Sullivan P. Outcomes of surgery for posterior segment intraocular foreign bodies--a retrospective review of 17 years of clinical experience. Graefes Arch Clin Exp Ophthalmol. 2006 Dec;244(12):1620-6. doi: 10.1007/s00417-006-0359-6.

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2022
• Primary Completion (Estimated): August 30, 2023
• Study Completion (Estimated): September 30, 2023

Study Registration Dates

• First Submitted: July 21, 2023
• First Submitted That Met QC Criteria: July 21, 2023
• First Posted (Actual): July 28, 2023

Study Record Updates

• Last Update Posted (Actual): July 28, 2023
• Last Update Submitted That Met QC Criteria: July 21, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Wounds and Injuries; Craniocerebral Trauma; Trauma, Nervous System; Facial Injuries; Eye Injuries; Foreign Bodies; Eye Foreign Bodies
• Other Study ID Numbers: ZU-IRB#9040/24-10-24

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No