Extraction Routes of Intraocular Foreign Body

Not Applicable

Recruiting

• Conditions: Intraocular Foreign Body
• Interventions: Procedure: pars plana vitrectomy and intraocular foreign body removal

• Registration Number: NCT05966545
• Lead Sponsor: Zagazig University

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.

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 Timeline

• Study Start: 2022-01-01
• Status Verified: 2023-07
• Study First Submitted: 2023-07-21
• Study First Submitted QC: 2023-07-21
• Last Update Submitted: 2023-07-21
• Study First Posted: 2023-07-28
• Last Update Posted: 2023-07-28
• Primary Completion: 2023-08-30
• Study Completion: 2023-09-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 48

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
intraocular foreign body extraction via the limbus	pars plana vitrectomy and intraocular foreign body removal	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.
intraocular foreign body extraction via the pars plana route	pars plana vitrectomy and intraocular foreign body removal	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.

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
associated intra operative and post-operative complications.	1, 3 and 6 months	report associated intra operative and post-operative complications
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.

Trial Locations

Locations (1)

faculty of medicine, Zagazig university; 🇪🇬 Zagazig, Sharkia, Egypt