Retinal Redetachment After Silicone Oil Removal : a Risk Factor Analysis
Sponsor
Central Hospital, Nancy, France (Other)
Overall Status
Completed
CT.gov ID
NCT05647928
Collaborator
(none)
307
1
1.8
166.9
Study Details
Study Description
Brief 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
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Study Design
Study Type:
Observational
Actual Enrollment
:
307 participants
Observational Model:
Cohort
Time Perspective:
Retrospective
Official Title:
Retinal Redetachment After Silicone Oil Removal : a Risk Factor Analysis
Actual Study Start Date
:
May 5, 2022
Actual Primary Completion Date
:
Jun 30, 2022
Actual Study Completion Date
:
Jun 30, 2022
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| retinal redetachment after silicone oil removal
|
Other: no intervention
no intervention
|
| NO retinal redetachment after silicone oil removal
|
Other: no intervention
no intervention
|
Outcome Measures
Primary Outcome Measures
- rate of retinal redetachment after silicone oil removal [a minimum period of 6 months after silicone oil removal]
- pre- and intraoperative risk factors of retinal redetachment after silicone oil removal [a minimum period of 6 months after silicone oil removal]
Secondary Outcome Measures
- final retinal reattachment rate [a minimum period of 6 months after silicone oil removal]
- final best corrected visual acuity [a minimum period of 6 months after silicone oil removal]
Eligibility Criteria
Criteria
Ages Eligible for Study:
N/A
and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
-
patients with successfully repaired rhegmatogenous retinal detachment and subsequent silicone oil removal
-
minimum follow-up period of 6 months after silicone oil removal
Exclusion Criteria:
-
Silicone oil tamponade for indications other than rhegmatogenous retinal detachment
-
Retinal redetachment during silicone oil tamponade
-
Prior history of silicone oil tamponade
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | CHRU Nancy Brabois | Vandœuvre-lès-nancy | France | 54500 |
Sponsors and Collaborators
- Central Hospital, Nancy, France
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
Professeur Jean-Baptiste CONART,
MD PhD,
Central Hospital, Nancy, France
ClinicalTrials.gov Identifier:
NCT05647928
Other Study ID Numbers:
- 2022PI084
First Posted:
Dec 13, 2022
Last Update Posted:
Dec 13, 2022
Last Verified:
Dec 1, 2022
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Professeur Jean-Baptiste CONART,
MD PhD,
Central Hospital, Nancy, France