Vitreous Inflammation in Standard and Heavy Silicone Oil

May 1, 2017 updated by: Francesco Semeraro, Università degli Studi di Brescia

The inflammatory response after prolonged retinal detachment and after vitreoretinal surgery has its apex in the development of PVR that occurs when retinal cells are exposed to the inflammatory milieu in the humor vitreous.

This situation is common in complicated retinal detachment, but is amplified after invasive surgery and by the use of intraocular tamponades that float over a subtle film of liquid where the inflammatory cytokines and growth factors reach the critical concentration over the inferior retina.

Many authors have noted that the heavy tamponade are more prone to cause intraocular inflammation compared to standard silicone oil, especially if they remain for several months in the eye.

The purpose of this study is to measure the vitreous concentration of some of the most important cytokines involved in the inflammatory vitreal response.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

70

Phase

  • Not Applicable

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

Description

Inclusion Criteria:

  • patient scheduled for vitrectomy

Exclusion Criteria:

  • diabetic retinopathy
  • uveitis

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

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Standard silicone oil
after vitreous removal, the vitreous chamber was filled with standard silicone oil (PDMS)
Device: Vitreous Tamponade with Silicone Oil
Experimental: Heavy silicone oil
after vitreous removal, the vitreous chamber was filled with heavy silicone oil (Densiron 68)
Device: Vitreous Tamponade with Silicone Oil

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Vitreous Prostaglandin E2 Levels
Time Frame: intraoperarive
intraoperarive

Collaborators and Investigators

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

Sponsor

Università degli Studi di Brescia

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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

June 1, 2015

Primary Completion (Actual)

December 1, 2015

Study Registration Dates

First Submitted

January 25, 2016

First Submitted That Met QC Criteria

February 3, 2016

First Posted (Estimate)

February 5, 2016

Study Record Updates

Last Update Posted (Actual)

June 2, 2017

Last Update Submitted That Met QC Criteria

May 1, 2017

Last Verified

May 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Vitreo002

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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