Clinical trial NCT05966545: Extraction Routes of Intraocular Foreign Body
Official title: Outcomes of Retained Posterior Segment Intraocular Foreign Body Extraction With Coexisting Cataract Via The Limbus or The Pars Plana Route
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Intraocular Foreign Body
Lead sponsor: Zagazig University
Sponsor class: OTHER_GOV
First posted: 2023-07-28
Enrollment: 48
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: post-operative retinal detachment
timeFrame: 1, 3 and 6 months
Secondary outcomes:
measure: post-operative best corrected visual acuity
timeFrame: 1, 3 and 6 months
measure: associated intra operative and post-operative complications.
timeFrame: 1, 3 and 6 months
Other outcomes:
Locations:
city: Zagazig
country: Egypt
facility: faculty of medicine, Zagazig university
state: Sharkia
Study officials:
affiliation: Zagazig University
name: sherif A. Dabour, MD
role: STUDY_DIRECTOR
affiliation: Zagazig University
name: Ahmad S. Khalil, MD
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.