Silicone Oil Filled EyesNCT05087901
Multifocal Electroretinography Before and After Silicone Oil Removal
An observational study of Silicone Oil Filled Eyes, run by Minia University at 1 site in Egypt.
Trial summary
This is a prospective observational study to investigate the changes in multifocal electroretinogram signal before and after silicone oil removal in silicone-filled eyes. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Silicone Oil Filled Eyes
- What is being tested?
- Multifocal electroretinogram
- How many people
- 30 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Oct 2021to 31 Mar 2022
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: A total of 30 patients will be recruited. We will include patients 18 years of age or older who underwent PPV for the repair of rhegmatogenous retinal detachment (RRD) and received silicone oil as an intraocular tamponade. Patients will be excluded if they have a significant corneal opacity, uncontrolled intraocular pressure, a confounding macular pathology or optic nerve pathology or if silicone oil has been in the eye for longer than 6 months.
Who may be able to join
- Patients 18 years of age or older who underwent pars plana vitrectomy for the repair of rhegmatogenous retinal detachment (RRD) and received silicone oil as an intraocular tamponade.
Who cannot join
- Patients will be excluded if they have a significant corneal opacity, uncontrolled intraocular pressure, a confounding macular pathology or optic nerve pathology or if silicone oil has been in the eye for longer than 6 months.
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Minia University Hospital
Minya, 61111
Mohamed A Hamid, MD, +201024289366, drmohamedhamid83@mu.edu.eg
About this study
This is a prospective observational study to investigate the changes in multifocal electroretinogram signal before and after silicone oil removal in silicone-filled eyes.
- Conditions
- Silicone Oil Filled Eyes
- Being tested
- Multifocal electroretinogram
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Multifocal electroretinogramDiagnostic test
A device that records electric potentials generated by the retinal photoreceptors and neural elements in a multifocal fashion
| Study group | Role | What they receive |
|---|---|---|
| Silicone-filled eyes | Not described Receives: Diagnostic Test: Multifocal electroretinogram |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Amplitude
Change in amplitudes of P1 and N1 waves before and after silicone oil removal
Measured: Preoperative and 1 month postoperative recordings
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Oct 2021
- Study start1 Oct 2021
- Primary completion31 Jan 2022 (estimated)
- Study completion31 Mar 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Silicone Oil Filled EyesStudies of the same condition, open and under way.
- More trials run by Minia 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Minia University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohamed Abdel Hamid, Minia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05087901
- Sponsor's protocol ID
- 34:3/2021
- Status last verified
- Oct 2021
- First submitted
- 9 Oct 2021
- Last updated
- 21 Oct 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 21 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multifocal Electroretinography Before and After Silicone Oil Removal
- ClinicalTrials.gov ID
- NCT05087901
- Acronym / sponsor ID
- 34:3/2021
- Conditions
- Silicone Oil Filled Eyes
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Minia UniversityUniversity, hospital or other
- Study start
- 1 Oct 2021 (actual)
- Primary completion
- 31 Jan 2022 (estimated)
- Study completion
- 31 Mar 2022 (estimated)
- First posted
- 21 Oct 2021 (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.
This is a prospective observational study to investigate the changes in multifocal electroretinogram signal before and after silicone oil removal in silicone-filled eyes.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Silicone-filled eyes | – | Diagnostic Test: Multifocal electroretinogram |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- A total of 30 patients will be recruited. We will include patients 18 years of age or older who underwent PPV for the repair of rhegmatogenous retinal detachment (RRD) and received silicone oil as an intraocular tamponade. Patients will be excluded if they have a significant corneal opacity, uncontrolled intraocular pressure, a confounding macular pathology or optic nerve pathology or if silicone oil has been in the eye for longer than 6 months.
Key inclusion criteria (1 listed)
- Patients 18 years of age or older who underwent pars plana vitrectomy for the repair of rhegmatogenous retinal detachment (RRD) and received silicone oil as an intraocular tamponade.
Key exclusion criteria (1 listed)
- Patients will be excluded if they have a significant corneal opacity, uncontrolled intraocular pressure, a confounding macular pathology or optic nerve pathology or if silicone oil has been in the eye for longer than 6 months.
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 |
|---|---|---|
| Multifocal electroretinogramA device that records electric potentials generated by the retinal photoreceptors and neural elements in a multifocal fashion | Diagnostic test | Silicone-filled eyes |
Primary outcome
Change in Amplitude
Time frame: Preoperative and 1 month postoperative recordings
Change in amplitudes of P1 and N1 waves before and after silicone oil removal
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Oct 2021.
- Individual participant dataSharing planned: Undecided
Related trials for Silicone Oil Filled Eyes
Active, not recruitingObservational study
Corneal Endothelial Cell Changes In Silicon Filled Eye
Rhegmatogenous Macula-off Retinal Detachment
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Silicone Oil Filled Eyes, run by Minia 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 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: status not confirmed, as of the sponsor's last update on 21 Oct 2021. 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Amplitude (time frame: Preoperative and 1 month postoperative recordings). 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 21 Oct 2021.