Intraocular Foreign BodyIOFBNCT05966545
Extraction Routes of Intraocular Foreign Body
A study testing pars plana vitrectomy and intraocular foreign body removal in people with Intraocular Foreign Body, run by Zagazig University at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Intraocular Foreign Body
- What is being tested?
- pars plana vitrectomy and intraocular foreign body removal
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jan 2022to 30 Sep 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
faculty of medicine, Zagazig university
Zagazig, Sharqia Province, 44511
Abbas A. Ali Hashem, Msc, 01066227749 ext. 002, aaahashem@medicine.zu.edu.eg
Wael M. EL Haig, MD, 01222155744 ext. 002, waelmohamed@medicine.zu.edu.eg
About this study
Official title: 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.
Read the 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.
- Conditions
- Intraocular Foreign Body
- Being tested
- pars plana vitrectomy and intraocular foreign body removal
- Medical subject headings
- Eye Foreign Bodies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
pars plana vitrectomy and intraocular foreign body removalProcedure or surgery
removal of vitreous body and attachment to foreign body then extraction of foreign body
| Study group | Role | What they receive |
|---|---|---|
| intraocular foreign body extraction via the limbus | Active comparator | 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. Receives: Procedure: pars plana vitrectomy and intraocular foreign body removal |
| intraocular foreign body extraction via the pars plana route | Active comparator | 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. Receives: Procedure: pars plana vitrectomy and intraocular foreign body removal |
What is being measured
The primary outcome is the main question the study is designed to answer.
post-operative retinal detachment
comparing incidence of post-operative retinal detachment after intraocular foreign body extraction via limbus versus pars plana route.
Measured: 1, 3 and 6 months
Secondary outcomes (2)
post-operative best corrected visual acuity
report post-operative best corrected visual acuity after intraocular foreign body extraction via limbus versus pars plana route.
Measured: 1, 3 and 6 months
associated intra operative and post-operative complications.
report associated intra operative and post-operative complications
Measured: 1, 3 and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jul 2023
- Study start1 Jan 2022
- Primary completion30 Aug 2023 (estimated)
- Study completion30 Sep 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Intraocular Foreign BodyStudies of the same condition, open and under way.
- More trials run by Zagazig UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 48 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zagazig University
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Abbas Abomesslam Ali Hashem, Zagazig University
- Investigators
- sherif A. Dabour, MD, Study director, Zagazig UniversityAhmad S. Khalil, MD, Study director, Zagazig University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05966545
- Sponsor's protocol ID
- ZU-IRB#9040/24-10-24
- Acronym
- IOFB
- Status last verified
- Jul 2023
- First submitted
- 21 Jul 2023
- Last updated
- 28 Jul 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
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.
PubMed 16385302Loporchio 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.
PubMed 26994871Wani 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.
PubMed 14574250Wickham 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.
PubMed 16788826
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Outcomes of Retained Posterior Segment Intraocular Foreign Body Extraction With Coexisting Cataract Via The Limbus or The Pars Plana Route
- ClinicalTrials.gov ID
- NCT05966545
- Acronym / sponsor ID
- IOFB / ZU-IRB#9040/24-10-24
- Conditions
- Intraocular Foreign Body
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 48 participants (estimated)
- Lead sponsor
- Zagazig UniversityOther government
- Study start
- 1 Jan 2022 (actual)
- Primary completion
- 30 Aug 2023 (estimated)
- Study completion
- 30 Sep 2023 (estimated)
- First posted
- 28 Jul 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| intraocular foreign body extraction via the limbus | Active comparator | Procedure: pars plana vitrectomy and intraocular foreign body removalpars 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 | Active comparator | Procedure: pars plana vitrectomy and intraocular foreign body removalpars 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. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| pars plana vitrectomy and intraocular foreign body removalremoval of vitreous body and attachment to foreign body then extraction of foreign body | Procedure or surgery | intraocular foreign body extraction via the limbus, intraocular foreign body extraction via the pars plana route |
Primary outcome
post-operative retinal detachment
Time frame: 1, 3 and 6 months
comparing incidence of post-operative retinal detachment after intraocular foreign body extraction via limbus versus pars plana route.
2 secondary outcomes
post-operative best corrected visual acuity
Time frame: 1, 3 and 6 months
associated intra operative and post-operative complications.
Time frame: 1, 3 and 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jul 2023.
- Background: PubMed 16385302Demircan 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.
- Background: PubMed 26994871Loporchio 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.
- Background: PubMed 14574250Wani 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.
- Background: PubMed 16788826Wickham 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.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
sherif A. Dabour, MD study director
Zagazig University
Ahmad S. Khalil, MD study director
Zagazig University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing pars plana vitrectomy and intraocular foreign body removal in people with Intraocular Foreign Body, run by Zagazig University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 28 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Abbas A. Ali Hashem, MSc (01066227749 ext. 002, aaahashem@medicine.zu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
post-operative retinal detachment (time frame: 1, 3 and 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05966545, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jul 2023.