Retinal Redetachment After Silicone Oil Removal : a Risk Factor Analysis

December 4, 2022 updated by: Professeur Jean-Baptiste CONART, Central Hospital, Nancy, France
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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

307

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Vandœuvre-lès-nancy, France, 54500
        • CHRU Nancy Brabois

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Retrospective

Cohorts and Interventions

Group / Cohort
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
rate of retinal redetachment after silicone oil removal
Time Frame: a minimum period of 6 months 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
Time Frame: a minimum period of 6 months after silicone oil removal
a minimum period of 6 months after silicone oil removal

Secondary Outcome Measures

Outcome Measure
Time Frame
final retinal reattachment rate
Time Frame: a minimum period of 6 months after silicone oil removal
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
a minimum period of 6 months after silicone oil removal

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Central Hospital, Nancy, France

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 5, 2022

Primary Completion (Actual)

June 30, 2022

Study Completion (Actual)

June 30, 2022

Study Registration Dates

First Submitted

December 4, 2022

First Submitted That Met QC Criteria

December 4, 2022

First Posted (Actual)

December 13, 2022

Study Record Updates

Last Update Posted (Actual)

December 13, 2022

Last Update Submitted That Met QC Criteria

December 4, 2022

Last Verified

December 1, 2022

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 2022PI084

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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