Vitreous Inflammation
Conditions
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.
Interventions
DEVICEVitreous Tamponade with Silicone Oil
Sponsors
Università degli Studi di Brescia
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* patient scheduled for vitrectomy
Exclusion criteria
* diabetic retinopathy * uveitis
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Vitreous Prostaglandin E2 Levels | intraoperarive |
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Standard Silicone Oil after vitreous removal, the vitreous chamber was filled with standard silicone oil (PDMS)
Vitreous Tamponade with Silicone Oil | 15 |
| Heavy Silicone Oil after vitreous removal, the vitreous chamber was filled with heavy silicone oil (Densiron 68)
Vitreous Tamponade with Silicone Oil | 20 |
| Total | 35 |
Baseline characteristics
| Characteristic | Heavy Silicone Oil | Standard Silicone Oil | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 4 Participants | 5 Participants | 9 Participants |
| Age, Categorical Between 18 and 65 years | 16 Participants | 10 Participants | 26 Participants |
| Age, Continuous | 62.3 years STANDARD_DEVIATION 16.7 | 58.9 years STANDARD_DEVIATION 12.8 | 60.4 years STANDARD_DEVIATION 14.6 |
| Region of Enrollment Italy | 20 participants | 15 participants | 35 participants |
| Sex: Female, Male Female | 5 Participants | 4 Participants | 9 Participants |
| Sex: Female, Male Male | 15 Participants | 11 Participants | 26 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 15 | 0 / 20 |
| serious Total, serious adverse events | 0 / 15 | 0 / 20 |
Outcome results
Primary
Vitreous Prostaglandin E2 Levels
Time frame: intraoperarive
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Standard Silicone Oil | Vitreous Prostaglandin E2 Levels | 369.38 pg/mL | Standard Deviation 209.7 |
| Heavy Silicone Oil | Vitreous Prostaglandin E2 Levels | 869.16 pg/mL | Standard Deviation 242.83 |