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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Standard silicone oil | Experimental | after vitreous removal, the vitreous chamber was filled with standard silicone oil (PDMS) |
|
| Heavy silicone oil | Experimental | after vitreous removal, the vitreous chamber was filled with heavy silicone oil (Densiron 68) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Vitreous Tamponade with Silicone Oil | Device |
|
| Measure | Description | Time Frame |
|---|---|---|
| Vitreous Prostaglandin E2 Levels | intraoperarive |
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Inclusion Criteria:
Exclusion Criteria:
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32408387 | Derived | 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. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Standard Silicone Oil | after vitreous removal, the vitreous chamber was filled with standard silicone oil (PDMS) Vitreous Tamponade with Silicone Oil |
| FG001 | Heavy Silicone Oil | after vitreous removal, the vitreous chamber was filled with heavy silicone oil (Densiron 68) Vitreous Tamponade with Silicone Oil |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Standard Silicone Oil | after vitreous removal, the vitreous chamber was filled with standard silicone oil (PDMS) Vitreous Tamponade with Silicone Oil |
| BG001 | Heavy Silicone Oil |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Vitreous Prostaglandin E2 Levels | Posted | Mean | Standard Deviation | pg/mL | intraoperarive |
|
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Standard Silicone Oil | after vitreous removal, the vitreous chamber was filled with standard silicone oil (PDMS) Vitreous Tamponade with Silicone Oil |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Francesco Semeraro | University of Brescia | +30 030 3995308 | francesco.semeraro@unibs.it |
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after vitreous removal, the vitreous chamber was filled with heavy silicone oil (Densiron 68)
Vitreous Tamponade with Silicone Oil
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Participants |
|
|
| 0 |
| 15 |
| 0 |
| 15 |
| EG001 | Heavy Silicone Oil | after vitreous removal, the vitreous chamber was filled with heavy silicone oil (Densiron 68) Vitreous Tamponade with Silicone Oil | 0 | 20 | 0 | 20 |
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