NCT05647928

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
307

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started May 2022

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 5, 2022

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2022

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

December 4, 2022

Completed
9 days until next milestone

First Posted

Study publicly available on registry

December 13, 2022

Completed
Last Updated

December 13, 2022

Status Verified

December 1, 2022

Enrollment Period

2 months

First QC Date

December 4, 2022

Last Update Submit

December 4, 2022

Conditions

Keywords

rhegmatogenous retinal detachmentsilicone oilproliferative vitreoretinopathy

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (2)

  • 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

Study Arms (2)

retinal redetachment after silicone oil removal

Other: no intervention

NO retinal redetachment after silicone oil removal

Other: no intervention

Interventions

no intervention

NO retinal redetachment after silicone oil removalretinal redetachment after silicone oil removal

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

All patients who underwent pars plana vitrectomy with silicone oil tamponade at the Nancy University Hospital from January 2015 to January 2022.

You may qualify if:

  • patients with successfully repaired rhegmatogenous retinal detachment and subsequent silicone oil removal
  • minimum follow-up period of 6 months after silicone oil removal

You may not qualify if:

  • Silicone oil tamponade for indications other than rhegmatogenous retinal detachment
  • Retinal redetachment during silicone oil tamponade
  • Prior history of silicone oil tamponade

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHRU Nancy Brabois

Vandœuvre-lès-Nancy, 54500, France

Location

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Vitreoretinopathy, Proliferative

Condition Hierarchy (Ancestors)

Retinal DiseasesEye Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD PhD

Study Record Dates

First Submitted

December 4, 2022

First Posted

December 13, 2022

Study Start

May 5, 2022

Primary Completion

June 30, 2022

Study Completion

June 30, 2022

Last Updated

December 13, 2022

Record last verified: 2022-12

Locations