Vitreous Inflammation in Standard and Heavy Silicone Oil
1 other identifier
interventional
70
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
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Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2015
CompletedFirst Submitted
Initial submission to the registry
January 25, 2016
CompletedFirst Posted
Study publicly available on registry
February 5, 2016
CompletedResults Posted
Study results publicly available
June 2, 2017
CompletedJune 2, 2017
May 1, 2017
6 months
January 25, 2016
May 1, 2017
May 1, 2017
Conditions
Outcome Measures
Primary Outcomes (1)
Vitreous Prostaglandin E2 Levels
intraoperarive
Study Arms (2)
Standard silicone oil
EXPERIMENTALafter vitreous removal, the vitreous chamber was filled with standard silicone oil (PDMS)
Heavy silicone oil
EXPERIMENTALafter vitreous removal, the vitreous chamber was filled with heavy silicone oil (Densiron 68)
Interventions
Eligibility Criteria
You may qualify if:
- patient scheduled for vitrectomy
You may not qualify if:
- diabetic retinopathy
- uveitis
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Related Publications (1)
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.
PMID: 32408387DERIVED
Results Point of Contact
- Title
- Francesco Semeraro
- Organization
- University of Brescia
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- To Compare Vitreous Inflammation in Standard Versus Heavy Silicone Oil
Study Record Dates
First Submitted
January 25, 2016
First Posted
February 5, 2016
Study Start
June 1, 2015
Primary Completion
December 1, 2015
Last Updated
June 2, 2017
Results First Posted
June 2, 2017
Record last verified: 2017-05