Trial Outcomes & Findings for Vitreous Inflammation in Standard and Heavy Silicone Oil (NCT NCT02675543)
NCT ID: NCT02675543
Last Updated: 2017-06-02
Results Overview
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
70 participants
Primary outcome timeframe
intraoperarive
Results posted on
2017-06-02
Participant Flow
Participant milestones
| Measure |
Standard Silicone Oil
after vitreous removal, the vitreous chamber was filled with standard silicone oil (PDMS)
Vitreous Tamponade with Silicone Oil
|
Heavy Silicone Oil
after vitreous removal, the vitreous chamber was filled with heavy silicone oil (Densiron 68)
Vitreous Tamponade with Silicone Oil
|
|---|---|---|
|
Overall Study
STARTED
|
15
|
20
|
|
Overall Study
COMPLETED
|
15
|
20
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Vitreous Inflammation in Standard and Heavy Silicone Oil
Baseline characteristics by cohort
| Measure |
Standard Silicone Oil
n=15 Participants
after vitreous removal, the vitreous chamber was filled with standard silicone oil (PDMS)
Vitreous Tamponade with Silicone Oil
|
Heavy Silicone Oil
n=20 Participants
after vitreous removal, the vitreous chamber was filled with heavy silicone oil (Densiron 68)
Vitreous Tamponade with Silicone Oil
|
Total
n=35 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
10 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
26 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
5 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Age, Continuous
|
58.9 years
STANDARD_DEVIATION 12.8 • n=5 Participants
|
62.3 years
STANDARD_DEVIATION 16.7 • n=7 Participants
|
60.4 years
STANDARD_DEVIATION 14.6 • n=5 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
11 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
26 Participants
n=5 Participants
|
|
Region of Enrollment
Italy
|
15 participants
n=5 Participants
|
20 participants
n=7 Participants
|
35 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: intraoperariveOutcome measures
| Measure |
Standard Silicone Oil
n=15 Participants
after vitreous removal, the vitreous chamber was filled with standard silicone oil (PDMS)
Vitreous Tamponade with Silicone Oil
|
Heavy Silicone Oil
n=20 Participants
after vitreous removal, the vitreous chamber was filled with heavy silicone oil (Densiron 68)
Vitreous Tamponade with Silicone Oil
|
|---|---|---|
|
Vitreous Prostaglandin E2 Levels
|
369.38 pg/mL
Standard Deviation 209.7
|
869.16 pg/mL
Standard Deviation 242.83
|
Adverse Events
Standard Silicone Oil
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Heavy Silicone Oil
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place