Quantification of Silicone Oil Emulsification After Pars Plana Vitrectomy

October 26, 2021 updated by: Ospedale Policlinico San Martino
silicone oil tamponade removal after previous injection of complicated retinal detachment can be achieved with active suction followed by triple air-fluid exchange or prolonged lavage of the vitreous chamber to remove emulsification. Purpose of the study is to compare the amount of silicone oil emulsification droplets within the lavage fluid in case of air exchange and simple lavage to compare which technique removed the highest percentage of emulsion. This is achieved by comparing consecutive samples of lavage fluid

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

silicone oil tamponade removal after previous injection of complicated retinal detachment can be achieved with active suction followed by triple air-fluid exchange or prolonged lavage of the vitreous chamber to remove emulsification. Purpose of the study is to compare the amount of silicone oil emulsification droplets within the lavage fluid in case of air exchange and simple lavage to compare which technique removed the highest percentage of emulsion. This is achieved by comparing consecutive samples of lavage fluid.

Therefore consecutive patients scheduled to SiO removal with triple air exchange or vitreous chamber lavage are enrolled and 3 samples of intraocular fluid aspirated during the fluid exchange procedure sent to the lab for SiO emulsion count and quantification.

Study Type

Observational

Enrollment (Anticipated)

20

Contacts and Locations

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

Study Contact

Study Locations

  • Italy
    • RM
      • Genova, RM, Italy, 16100
        • Recruiting
        • IRCCS Policlinico San Martino

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

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

patients undergoing previous retinal detachment surgery with pars plana vitrectomy with silicone oil tamponade

Description

Inclusion Criteria:

  • previous silicone oil tamponade after pars plana vitrectomy
  • age >18 years
  • Attached retina

Exclusion Criteria:

  • unwilling or unable to participate,
  • previous multiple eye surgery
  • History of Trauma

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

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
triple air fluid exchange
those undergoing triple air fluid exchange
Procedure: pars plana vitrectomy
silicone oil active aspiration and isovolumetric BSS replacement followed by irrigation and /o gas fluid exchange
irrigation
those undergoing vitreous chamber irrigation with comparable volume of BSS
Procedure: pars plana vitrectomy
silicone oil active aspiration and isovolumetric BSS replacement followed by irrigation and /o gas fluid exchange

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
number of silicone oil emulsification droplets per volume unit
Time Frame: 6 months after primary surgery
number of silicone oil emulsification droplets per volume unit. Fluid taken from the vitreous chamber during surgery is subsequently analyzed. Therefore time frame is just one: after taking all samples they are analyzed to count oil droplets per volume unit
6 months after primary surgery

Collaborators and Investigators

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

Sponsor

Ospedale Policlinico San Martino

Investigators

  • Study Director: Tommaso Rossi, IRCCS Policlinico San Martino

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)

June 1, 2021

Primary Completion (ACTUAL)

September 1, 2021

Study Completion (ANTICIPATED)

November 3, 2021

Study Registration Dates

First Submitted

September 16, 2020

First Submitted That Met QC Criteria

February 24, 2021

First Posted (ACTUAL)

March 1, 2021

Study Record Updates

Last Update Posted (ACTUAL)

October 27, 2021

Last Update Submitted That Met QC Criteria

October 26, 2021

Last Verified

September 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1/2000

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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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