search
Back to results

Vitreous Inflammation in Standard and Heavy Silicone Oil

Primary Purpose

Vitreous Inflammation

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Vitreous Tamponade with Silicone Oil
Sponsored by
Università degli Studi di Brescia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Vitreous Inflammation

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • patient scheduled for vitrectomy

Exclusion Criteria:

  • diabetic retinopathy
  • uveitis

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Experimental

    Arm Label

    Standard silicone oil

    Heavy silicone oil

    Arm Description

    after vitreous removal, the vitreous chamber was filled with standard silicone oil (PDMS)

    after vitreous removal, the vitreous chamber was filled with heavy silicone oil (Densiron 68)

    Outcomes

    Primary Outcome Measures

    Vitreous Prostaglandin E2 Levels

    Secondary Outcome Measures

    Full Information

    First Posted
    January 25, 2016
    Last Updated
    May 1, 2017
    Sponsor
    Università degli Studi di Brescia
    search

    1. Study Identification

    Unique Protocol Identification Number
    NCT02675543
    Brief Title
    Vitreous Inflammation in Standard and Heavy Silicone Oil
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    May 2017
    Overall Recruitment Status
    Completed
    Study Start Date
    June 2015 (undefined)
    Primary Completion Date
    December 2015 (Actual)
    Study Completion Date
    undefined (undefined)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Università degli Studi di Brescia

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Vitreous Inflammation

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    70 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Standard silicone oil
    Arm Type
    Experimental
    Arm Description
    after vitreous removal, the vitreous chamber was filled with standard silicone oil (PDMS)
    Arm Title
    Heavy silicone oil
    Arm Type
    Experimental
    Arm Description
    after vitreous removal, the vitreous chamber was filled with heavy silicone oil (Densiron 68)
    Intervention Type
    Device
    Intervention Name(s)
    Vitreous Tamponade with Silicone Oil
    Primary Outcome Measure Information:
    Title
    Vitreous Prostaglandin E2 Levels
    Time Frame
    intraoperarive

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: patient scheduled for vitrectomy Exclusion Criteria: diabetic retinopathy uveitis

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    32408387
    Citation
    Schwartz SG, Flynn HW Jr, Wang X, Kuriyan AE, Abariga SA, Lee WH. Tamponade in surgery for retinal detachment associated with proliferative vitreoretinopathy. Cochrane Database Syst Rev. 2020 May 13;5(5):CD006126. doi: 10.1002/14651858.CD006126.pub4.
    Results Reference
    derived

    Learn more about this trial

    Vitreous Inflammation in Standard and Heavy Silicone Oil

    We'll reach out to this number within 24 hrs