Retinal Redetachment After Silicone Oil RemovalNCT05647928
Retinal Redetachment After Silicone Oil Removal : a Risk Factor Analysis
An observational study of Retinal Redetachment After Silicone Oil Removal, run by Central Hospital, Nancy, France at 1 site in France.
Trial summary
To report the rate of retinal redetachment after silicone oil removal (SOR) following rhegmatogenous retinal detachment (RRD) surgery and to determine potential risk factors Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Retinal Redetachment After Silicone Oil Removal
- How many people
- 307 participants
- Where
- 1 siteFrance
- Study dates
- 5 May 2022to 30 Jun 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: All patients who underwent pars plana vitrectomy with silicone oil tamponade at the Nancy University Hospital from January 2015 to January 2022.
Who may be able to join
- patients with successfully repaired rhegmatogenous retinal detachment and subsequent silicone oil removal
- minimum follow-up period of 6 months after silicone oil removal
Who cannot join
- Silicone oil tamponade for indications other than rhegmatogenous retinal detachment
- Retinal redetachment during silicone oil tamponade
- Prior history of silicone oil tamponade
Trial locations and contacts
1 site in 1 country.
About this study
To report the rate of retinal redetachment after silicone oil removal (SOR) following rhegmatogenous retinal detachment (RRD) surgery and to determine potential risk factors
- Being tested
- no intervention
- Keywords
- rhegmatogenous retinal detachment, silicone oil, proliferative vitreoretinopathy
- Medical subject headings
- Vitreoretinopathy, Proliferative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
no interventionOther
no intervention
| Study group | Role | What they receive |
|---|---|---|
| retinal redetachment after silicone oil removal | Not described Receives: Other: no intervention | |
| NO retinal redetachment after silicone oil removal | Not described Receives: Other: no intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
rate of retinal redetachment after silicone oil removal
Measured: a minimum period of 6 months after silicone oil removal
pre- and intraoperative risk factors of retinal redetachment after silicone oil removal
Measured: a minimum period of 6 months after silicone oil removal
Secondary outcomes (2)
final retinal reattachment rate
Measured: a minimum period of 6 months after silicone oil removal
final best corrected visual acuity
Measured: a minimum period of 6 months 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 posted13 Dec 2022
- Study start5 May 2022
- Primary completion30 Jun 2022
- Study completion30 Jun 2022
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 Redetachment After Silicone Oil RemovalStudies of the same condition, open and under way.
- More trials run by Central Hospital, Nancy, FranceThe 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
- Retrospective
- Enrolment
- 307 participants (actual)
Sponsor and investigators
- Lead sponsor
- Central Hospital, Nancy, France
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Professeur Jean-Baptiste CONART, Central Hospital, Nancy, France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05647928
- Sponsor's protocol ID
- 2022PI084
- Status last verified
- Dec 2022
- First submitted
- 4 Dec 2022
- Last updated
- 13 Dec 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Gisquet C, Ndiaye NC, Dubroux C, Angioi-Duprez K, Berrod JP, Conart JB. Retinal redetachment after silicone oil removal: a risk factor analysis. BMC Ophthalmol. 2024 Aug 15;24(1):346. doi: 10.1186/s12886-024-03618-z.
PubMed 39148018
Study at a glance
From the registry record, last updated by the sponsor on 13 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Retinal Redetachment After Silicone Oil Removal : a Risk Factor Analysis
- ClinicalTrials.gov ID
- NCT05647928
- Acronym / sponsor ID
- 2022PI084
- Keywords
- rhegmatogenous retinal detachment, silicone oil, proliferative vitreoretinopathy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 307 participants (actual)
- Lead sponsor
- Central Hospital, Nancy, FranceUniversity, hospital or other
- Study start
- 5 May 2022 (actual)
- Primary completion
- 30 Jun 2022 (actual)
- Study completion
- 30 Jun 2022 (actual)
- First posted
- 13 Dec 2022 (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.
To report the rate of retinal redetachment after silicone oil removal (SOR) following rhegmatogenous retinal detachment (RRD) surgery and to determine potential risk factors
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| retinal redetachment after silicone oil removal | – | Other: no intervention |
| NO retinal redetachment after silicone oil removal | – | Other: no intervention |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- All patients who underwent pars plana vitrectomy with silicone oil tamponade at the Nancy University Hospital from January 2015 to January 2022.
Key inclusion criteria (2 listed)
- patients with successfully repaired rhegmatogenous retinal detachment and subsequent silicone oil removal
- minimum follow-up period of 6 months after silicone oil removal
Key exclusion criteria (3 listed)
- Silicone oil tamponade for indications other than rhegmatogenous retinal detachment
- Retinal redetachment during silicone oil tamponade
- Prior history of silicone oil tamponade
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 |
|---|---|---|
| no interventionno intervention | Other | NO retinal redetachment after silicone oil removal, retinal redetachment after silicone oil removal |
Primary outcome
rate of retinal redetachment after silicone oil removal
Time frame: a minimum period of 6 months after silicone oil removal
pre- and intraoperative risk factors of retinal redetachment after silicone oil removal
Time frame: a minimum period of 6 months after silicone oil removal
2 secondary outcomes
final retinal reattachment rate
Time frame: a minimum period of 6 months after silicone oil removal
final best corrected visual acuity
Time frame: a minimum period of 6 months 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 13 Dec 2022.
- Derived from this study: PubMed 39148018Gisquet C, Ndiaye NC, Dubroux C, Angioi-Duprez K, Berrod JP, Conart JB. Retinal redetachment after silicone oil removal: a risk factor analysis. BMC Ophthalmol. 2024 Aug 15;24(1):346. doi: 10.1186/s12886-024-03618-z.
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 Redetachment After Silicone Oil Removal, run by Central Hospital, Nancy, France at 1 site in France.
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 3 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 13 Dec 2022. 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 France. 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?
rate of retinal redetachment after silicone oil removal (time frame: a minimum period of 6 months after silicone oil removal). The study lists 2 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 NCT05647928, 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 13 Dec 2022.