Retinal DetachmentsiliconeoilNCT05817630
Duration of Silicone Oil Tamponade on Foveal and Parafoveal Thickness in Rhegmatogenous Retinal Detachment
An observational study of Retinal Detachment, run by Dar El Oyoun Hospital at 1 site in Egypt.
Trial summary
Our study observes and analyses the influence of the duration of tamponade with silicone oil on the foveal and parafoveal thickness. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Retinal Detachment
- What is being tested?
- Silicone oil Tamponade for Retinal Detachment
- How many people
- 32 participants
- Where
- 1 siteEgypt
- Study dates
- 15 Feb 2023to 5 Apr 2023
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Retrospective Cohort study Retrospective review of records of eyes with Rhegmatogenous Retinal Detachment (RRD, for whom pars plana vitrectomy and silicone oil had been performed, in the period between January 2019 and December 2021.
Who may be able to join
- • Silicone oil (SO) tamponade ( up to 6 months)
- Attached retina under SO
- Attached retina 3 months after Silicone oil Removal (SOR)
- Normal fellow eye ( no retinal detachment or macular disease)
- OCT scan performed for the operated eyes (before SOR, and 3 months after SOR), and for the fellow eye (at any time during the study)
Who cannot join
- • Rhegmatogenous Retinal Detachment (RRD) with other tamponades ( e.g.: Gas, Densiron)
- SO tamponade less than 3 months, or more than 6 months
- Recurrent RD under SO
- Recurrent RD within 3 months after SOR
- One eyed
- Vitrectomized fellow eye
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- Retinal detachment, or macular disease in the fellow eye.
- Posterior staphyloma
- Anisometropia (history, refraction if possible, spectacles prescription)
- Absence of any of the OCT scans performed for the operated eyes (before SOR, and 3 months after SOR), and for the fellow eye (at any time during the study)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Impact of Duration of Silicone Oil Tamponade on Foveal and Parafoveal Thickness in Rhegmatogenous Retinal Detachment: A Retrospective Cohort Study
Our study observes and analyses the influence of the duration of tamponade with silicone oil on the foveal and parafoveal thickness.
Read the detailed description
Retrospective Cohort study Retrospective review of records of eyes with Rhegmatogenous Retinal Detachment (RRD, for whom pars plana vitrectomy and silicone oil had been performed, in the period between January 2019 and December 2021.
After checking inclusion and exclusion criteria; we will enroll all the cases.
We shall observe the duration of silicone oil tamponade, and then divide the cases; accordingly; into 2 groups (Cohort).
- Group A: 3 months SO Tamponade
- Group B: 6 months SO Tamponade
- Conditions
- Retinal Detachment
- Being tested
- Silicone oil Tamponade for Retinal Detachment
- Medical subject headings
- Retinal Detachment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Silicone oil Tamponade for Retinal DetachmentOther
eyes with Rhegmatogenous Retinal Detachment (RRD, for whom pars plana vitrectomy and silicone oil had been performed
| Study group | Role | What they receive |
|---|---|---|
| Group A | Group A: 3 months SO Tamponade Receives: Other: Silicone oil Tamponade for Retinal Detachment | |
| Group B | Group B: 6 months SO Tamponade Receives: Other: Silicone oil Tamponade for Retinal Detachment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in CFT just before SOR (central foveal thickness)
Change in CFT just before SOR (from baseline fellow eye) (microns, %) (each group)
Measured: baseline to time just before silicone oil removal
Change in PFT just before SOR (Parafoveal thickness)
Change in PFT just before SOR (from baseline fellow eye) (microns, %) (each group)
Measured: baseline to time just before silicone oil removal
• Change in CFT after SOR
- Change in CFT after SOR (from baseline fellow eye) (microns, %) (each group)
Measured: from baseline fellow eye to 1 month after silicone oil removal
• Change in PFT after SOR
- Change in PFT after SOR (from baseline fellow eye) (microns, %) (each group)
Measured: from baseline fellow eye to 1 month after silicone oil removal
Secondary outcomes (4)
• Relative Risk of severe CFT Thinning before SOR (between group A and B)
- Relative Risk of severe CFT Thinning before SOR (between group A and B)
Measured: baseline to time just before silicone oil removal
• Relative Risk of severe PFT Thinning before SOR (between group A and B
- Relative Risk of severe PFT Thinning before SOR (between group A and B
Measured: baseline to time just before silicone oil removal
• Relative Risk of severe CFT Thinning after SOR (between group A and B)
- Relative Risk of severe CFT Thinning after SOR (between group A and B)
Measured: from baseline fellow eye to 1 month after silicone oil removal
• Relative Risk of severe PFT Thinning after SOR (between group A and B)
- Relative Risk of severe PFT Thinning after SOR (between group A and B)
Measured: from baseline fellow eye to 1 month after silicone oil removal
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Apr 2023
- Study start15 Feb 2023
- Primary completion1 Apr 2023
- Study completion5 Apr 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Retinal DetachmentStudies of the same condition, open and under way.
- 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
- Retrospective
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dar El Oyoun Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Wael Ahmed Ewais, Dar El Oyoun Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05817630
- Sponsor's protocol ID
- N-19-2023
- Acronym
- siliconeoil
- Status last verified
- Apr 2023
- First submitted
- 5 Apr 2023
- Last updated
- 18 Apr 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Ewais WA, Ali LS, Aboalazayem FM. Impact of duration of silicone oil tamponade on foveal and parafoveal thickness in rhegmatogenous retinal detachment: a retrospective cohort study. Int Ophthalmol. 2024 Apr 2;44(1):167. doi: 10.1007/s10792-024-03096-8.
PubMed 38565753
Study at a glance
From the registry record, last updated by the sponsor on 18 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Duration of Silicone Oil Tamponade on Foveal and Parafoveal Thickness in Rhegmatogenous Retinal Detachment: A Retrospective Cohort Study
- ClinicalTrials.gov ID
- NCT05817630
- Acronym / sponsor ID
- siliconeoil / N-19-2023
- Conditions
- Retinal Detachment
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Dar El Oyoun HospitalUniversity, hospital or other
- Study start
- 15 Feb 2023 (actual)
- Primary completion
- 1 Apr 2023 (actual)
- Study completion
- 5 Apr 2023 (actual)
- First posted
- 18 Apr 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.
Our study observes and analyses the influence of the duration of tamponade with silicone oil on the foveal and parafoveal thickness.
Detailed description
Retrospective Cohort study Retrospective review of records of eyes with Rhegmatogenous Retinal Detachment (RRD, for whom pars plana vitrectomy and silicone oil had been performed, in the period between January 2019 and December 2021.
After checking inclusion and exclusion criteria; we will enroll all the cases.
We shall observe the duration of silicone oil tamponade, and then divide the cases; accordingly; into 2 groups (Cohort).
- Group A: 3 months SO Tamponade
- Group B: 6 months SO Tamponade
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A | – | Other: Silicone oil Tamponade for Retinal DetachmentGroup A: 3 months SO Tamponade |
| Group B | – | Other: Silicone oil Tamponade for Retinal DetachmentGroup B: 6 months SO Tamponade |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Retrospective Cohort study Retrospective review of records of eyes with Rhegmatogenous Retinal Detachment (RRD, for whom pars plana vitrectomy and silicone oil had been performed, in the period between January 2019 and December 2021.
Key inclusion criteria (5 listed)
- • Silicone oil (SO) tamponade ( up to 6 months)
Key exclusion criteria (10 listed)
- • Rhegmatogenous Retinal Detachment (RRD) with other tamponades ( e.g.: Gas, Densiron)
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 |
|---|---|---|
| Silicone oil Tamponade for Retinal Detachmenteyes with Rhegmatogenous Retinal Detachment (RRD, for whom pars plana vitrectomy and silicone oil had been performed | Other | Group A, Group B |
Primary outcome
Change in CFT just before SOR (central foveal thickness)
Time frame: baseline to time just before silicone oil removal
Change in CFT just before SOR (from baseline fellow eye) (microns, %) (each group)
Change in PFT just before SOR (Parafoveal thickness)
Time frame: baseline to time just before silicone oil removal
Change in PFT just before SOR (from baseline fellow eye) (microns, %) (each group)
• Change in CFT after SOR
Time frame: from baseline fellow eye to 1 month after silicone oil removal
• Change in CFT after SOR (from baseline fellow eye) (microns, %) (each group)
• Change in PFT after SOR
Time frame: from baseline fellow eye to 1 month after silicone oil removal
• Change in PFT after SOR (from baseline fellow eye) (microns, %) (each group)
4 secondary outcomes
• Relative Risk of severe CFT Thinning before SOR (between group A and B)
Time frame: baseline to time just before silicone oil removal
• Relative Risk of severe PFT Thinning before SOR (between group A and B
Time frame: baseline to time just before silicone oil removal
• Relative Risk of severe CFT Thinning after SOR (between group A and B)
Time frame: from baseline fellow eye to 1 month after silicone oil removal
• Relative Risk of severe PFT Thinning after SOR (between group A and B)
Time frame: from baseline fellow eye to 1 month after silicone oil removal
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 18 Apr 2023.
- Derived from this study: PubMed 38565753Ewais WA, Ali LS, Aboalazayem FM. Impact of duration of silicone oil tamponade on foveal and parafoveal thickness in rhegmatogenous retinal detachment: a retrospective cohort study. Int Ophthalmol. 2024 Apr 2;44(1):167. doi: 10.1007/s10792-024-03096-8.
- 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.
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 Retinal Detachment, run by Dar El Oyoun Hospital 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 5 inclusion and 10 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 18 Apr 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?
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?
Change in CFT just before SOR (central foveal thickness) (time frame: baseline to time just before silicone oil removal). The study lists 4 primary outcomes in all. 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 NCT05817630, which also lists 1 linked publication.
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 18 Apr 2023.