Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
48 participants
INTERVENTIONAL
2022-01-01
2023-09-30
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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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.
pars plana vitrectomy and intraocular foreign body removal
removal of vitreous body and attachment to foreign body then extraction of foreign body
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.
pars plana vitrectomy and intraocular foreign body removal
removal of vitreous body and attachment to foreign body then extraction of foreign body
Interventions
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pars plana vitrectomy and intraocular foreign body removal
removal of vitreous body and attachment to foreign body then extraction of foreign body
Eligibility Criteria
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Inclusion Criteria
* Eyes with retained posterior segment intraocular foreign body associated with coexisting cataract.
Exclusion Criteria
* 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
ALL
Yes
Sponsors
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Zagazig University
OTHER_GOV
Responsible Party
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Abbas Abomesslam Ali Hashem
assistant lecturer
Principal Investigators
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sherif A. Dabour, MD
Role: STUDY_DIRECTOR
Zagazig University
Ahmad S. Khalil, MD
Role: STUDY_DIRECTOR
Zagazig University
Locations
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faculty of medicine, Zagazig university
Zagazig, Sharqia Province, Egypt
Countries
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Central Contacts
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Facility Contacts
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Abbas A. Ali Hashem, Msc
Role: primary
Wael M. EL Haig, MD
Role: backup
References
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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.
Other Identifiers
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ZU-IRB#9040/24-10-24
Identifier Type: -
Identifier Source: org_study_id