Trial Outcomes & Findings for Using Triamcinolone Acetonide to Reduce Pain After Scleral Buckle Surgery (NCT NCT04701593)
NCT ID: NCT04701593
Last Updated: 2024-07-23
Results Overview
11-point Numerical Rating Scale (0-10, 10 being highest level of pain)
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
14 participants
Primary outcome timeframe
1 Day Post-Op
Results posted on
2024-07-23
Participant Flow
Participant milestones
| Measure |
Control
No additional drug given
|
Experimental (Triamcinolone Acetonide)
receives a sub-tenon irrigation of 1 cc 40mg/mL triamcinolone acetonide around the base of the scleral buckle (0.25 cc in each quadrant) at time of operation
Triamcinolone Acetonide 40mg/mL: Sub-tenon irrigation 1cc
|
|---|---|---|
|
Overall Study
STARTED
|
5
|
9
|
|
Overall Study
COMPLETED
|
5
|
9
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Using Triamcinolone Acetonide to Reduce Pain After Scleral Buckle Surgery
Baseline characteristics by cohort
| Measure |
Control
n=5 Participants
No additional drug given
|
Experimental (Triamcinolone Acetonide)
n=9 Participants
receives a sub-tenon irrigation of 1 cc 40mg/mL triamcinolone acetonide around the base of the scleral buckle (0.25 cc in each quadrant) at time of operation
Triamcinolone Acetonide 40mg/mL: Sub-tenon irrigation 1cc
|
Total
n=14 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Customized
<20 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Age, Customized
20-40 years
|
0 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
|
Age, Customized
40-65 years
|
5 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
9 Participants
n=206 Participants
|
|
Age, Customized
65+ years
|
0 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
6 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=99 Participants
|
6 Participants
n=107 Participants
|
8 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
5 Participants
n=99 Participants
|
9 Participants
n=107 Participants
|
14 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
5 participants
n=99 Participants
|
9 participants
n=107 Participants
|
14 participants
n=206 Participants
|
PRIMARY outcome
Timeframe: 1 Day Post-Op11-point Numerical Rating Scale (0-10, 10 being highest level of pain)
Outcome measures
| Measure |
Control
n=5 Participants
No additional drug given
|
Experimental (Triamcinolone Acetonide)
n=9 Participants
receives a sub-tenon irrigation of 1 cc 40mg/mL triamcinolone acetonide around the base of the scleral buckle (0.25 cc in each quadrant) at time of operation
Triamcinolone Acetonide 40mg/mL: Sub-tenon irrigation 1cc
|
|---|---|---|
|
Post Operative Pain Day 1
|
2.2 score on a scale
Interval 2.0 to 3.0
|
1.0 score on a scale
Interval 0.0 to 1.75
|
SECONDARY outcome
Timeframe: 1 Week Post-Op11-point Numerical Rating Scale (0-10, 10 being highest level of pain)
Outcome measures
| Measure |
Control
n=5 Participants
No additional drug given
|
Experimental (Triamcinolone Acetonide)
n=9 Participants
receives a sub-tenon irrigation of 1 cc 40mg/mL triamcinolone acetonide around the base of the scleral buckle (0.25 cc in each quadrant) at time of operation
Triamcinolone Acetonide 40mg/mL: Sub-tenon irrigation 1cc
|
|---|---|---|
|
Post Operative Pain Week 1
|
0.8 score on a scale
Interval 0.0 to 1.0
|
0 score on a scale
Interval 0.0 to 0.0
|
SECONDARY outcome
Timeframe: Cumulative amount used was assessed at one week after operationAmount of Tylenol used (in mg) cumulatively over one week after the operation
Outcome measures
| Measure |
Control
n=5 Participants
No additional drug given
|
Experimental (Triamcinolone Acetonide)
n=9 Participants
receives a sub-tenon irrigation of 1 cc 40mg/mL triamcinolone acetonide around the base of the scleral buckle (0.25 cc in each quadrant) at time of operation
Triamcinolone Acetonide 40mg/mL: Sub-tenon irrigation 1cc
|
|---|---|---|
|
Pain Medication Use (Tylenol in mg)
|
3125 milligrams
Interval 250.0 to 3300.0
|
2403 milligrams
Interval 0.0 to 2500.0
|
Adverse Events
Control
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Experimental (Triamcinolone Acetonide)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Control
n=5 participants at risk
No additional drug given
|
Experimental (Triamcinolone Acetonide)
n=9 participants at risk
receives a sub-tenon irrigation of 1 cc 40mg/mL triamcinolone acetonide around the base of the scleral buckle (0.25 cc in each quadrant) at time of operation
Triamcinolone Acetonide 40mg/mL: Sub-tenon irrigation 1cc
|
|---|---|---|
|
Eye disorders
Infection
|
0.00%
0/5 • 6 months after experimental treatment
There is no risk for mortality from the use of FDA approved intraocular steroids, no such event has ever been reported
|
0.00%
0/9 • 6 months after experimental treatment
There is no risk for mortality from the use of FDA approved intraocular steroids, no such event has ever been 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