Eye InjuriesNCT04595357
"Iris Shelf" Technique for Intraocular Foreign Bodies Removal
An observational study of Eye Injuries, run by Assiut University.
Trial summary
Intraocular foreign body (IOFB) injury is a common potentially serious form of ocular trauma. Metallic IOFB is the most common type of IOFB injury. Apart from the associated ocular tissue damage, Metallic IOFB may cause permanent visual impairment due to retinal toxicity and endophthalmitis. Read more about this study
- Who is it for?
- Ages 15 to 45 years
- Conditions the study is for
- Eye Injuries
- What is being tested?
- Iris shelf technique
- Type of treatment
- Surgery or procedure
- How many people
- 33 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2016to 1 Jul 2020
- Phase
- Observational
- 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 15 to 45 years
- All sexes
- Child, Adult
Study population: patients with posterior segment metallic IOFB who underwent combined phacovitrectomy with IOFB removal through a clear corneal incision using "Iris shelf" technique at Assiut University hospitals and Al-Forsan eye center, Assiut; Egypt in the period between January 2016 and December 2019.
Who may be able to join
- posterior segment metallic IOFB who underwent combined phacovitrectomy with IOFB removal through a clear corneal incision using "Iris shelf" technique
Who cannot join
- Any other surgical technique for posterior segment IOFB removal
About this study
Intraocular foreign body (IOFB) injury is a common potentially serious form of ocular trauma. Metallic IOFB is the most common type of IOFB injury. Apart from the associated ocular tissue damage, Metallic IOFB may cause permanent visual impairment due to retinal toxicity and endophthalmitis.
When presenting posteriorly, the approach of IOFB removal is challenging. Several techniques had been described for posterior IOFB removal. All of these techniques aimed to remove IOFB with the least possible collateral damage. This study aims to describe "Iris shelf" technique for posterior IOFB removal through a clear corneal incision combined with phaco-vitrectomy and report its outcomes.
- Conditions
- Eye Injuries
- Being tested
- Iris shelf technique
- Medical subject headings
- Eye Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Iris shelf techniqueProcedure or surgery
Removal of posterior segment intraocular foreign bodies through corneal incision combined with phaco-vitrectomy
What is being measured
The primary outcome is the main question the study is designed to answer.
corrected distance visual acuity
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Oct 2020
- Study start1 Jan 2016
- Primary completion31 Dec 2019
- Study completion1 Jul 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Eye InjuriesStudies of the same condition, open and under way.
- More trials run by Assiut 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
- Observational
- Observational model
- Case only
- Time perspective
- Retrospective
- Enrolment
- 33 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Khaled Abdelazeem, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04595357
- Sponsor's protocol ID
- 17300500
- Status last verified
- Oct 2020
- First submitted
- 14 Oct 2020
- Last updated
- 20 Oct 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- "Iris Shelf" Technique for Intraocular Foreign Bodies Removal
- ClinicalTrials.gov ID
- NCT04595357
- Acronym / sponsor ID
- 17300500
- Conditions
- Eye Injuries
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 33 participants (actual)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Jan 2016 (actual)
- Primary completion
- 31 Dec 2019 (actual)
- Study completion
- 1 Jul 2020 (actual)
- First posted
- 20 Oct 2020 (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.
Intraocular foreign body (IOFB) injury is a common potentially serious form of ocular trauma. Metallic IOFB is the most common type of IOFB injury. Apart from the associated ocular tissue damage, Metallic IOFB may cause permanent visual impairment due to retinal toxicity and endophthalmitis.
When presenting posteriorly, the approach of IOFB removal is challenging. Several techniques had been described for posterior IOFB removal. All of these techniques aimed to remove IOFB with the least possible collateral damage. This study aims to describe "Iris shelf" technique for posterior IOFB removal through a clear corneal incision combined with phaco-vitrectomy and report its outcomes.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
Who may qualify
- Ages
- 15 to 45 years
- Sex
- All
- Age groups
- Child, Adult
- Study population
- patients with posterior segment metallic IOFB who underwent combined phacovitrectomy with IOFB removal through a clear corneal incision using "Iris shelf" technique at Assiut University hospitals and Al-Forsan eye center, Assiut; Egypt in the period between January 2016 and December 2019.
Key inclusion criteria (1 listed)
- posterior segment metallic IOFB who underwent combined phacovitrectomy with IOFB removal through a clear corneal incision using "Iris shelf" technique
Key exclusion criteria (1 listed)
- Any other surgical technique for posterior segment IOFB removal
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 |
|---|---|---|
| Iris shelf techniqueRemoval of posterior segment intraocular foreign bodies through corneal incision combined with phaco-vitrectomy | Procedure or surgery | – |
Primary outcome
corrected distance visual acuity
Time frame: 1 month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Oct 2020.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Eye Injuries, run by Assiut University.
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 1 inclusion and 1 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: finished, as of the sponsor's last update on 20 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
corrected distance visual acuity (time frame: 1 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 20 Oct 2020.