Trial Outcomes & Findings for Comparing Preoperative Injection of Mitomycin-C vs. Intraoperative Injection of Mitomycin-C vs. Topical Application of Mitomycin-C (Conventional Use) in Trabeculectomy (NCT NCT03875911)
NCT ID: NCT03875911
Last Updated: 2024-01-05
Results Overview
Mean IOP at 1 day post-operatively
Recruitment status
TERMINATED
Study phase
PHASE4
Target enrollment
19 participants
Primary outcome timeframe
1 day
Results posted on
2024-01-05
Participant Flow
Unit of analysis: Eyes
Participant milestones
| Measure |
Group A - Pre-operative Injection
Recieved a pre-operative injection of mitomycin-C prior to trabeculectomy
|
Group B - Intra-operative Injection
Recieved an intra-operative injection of mitomycin-C
|
Group C - Control
Recieved standard of care - topical application of mitomycin-C
|
|---|---|---|---|
|
Overall Study
STARTED
|
6 7
|
7 7
|
6 6
|
|
Overall Study
COMPLETED
|
2 3
|
1 1
|
2 2
|
|
Overall Study
NOT COMPLETED
|
4 4
|
6 6
|
4 4
|
Reasons for withdrawal
| Measure |
Group A - Pre-operative Injection
Recieved a pre-operative injection of mitomycin-C prior to trabeculectomy
|
Group B - Intra-operative Injection
Recieved an intra-operative injection of mitomycin-C
|
Group C - Control
Recieved standard of care - topical application of mitomycin-C
|
|---|---|---|---|
|
Overall Study
Lost to Follow-up
|
3
|
6
|
2
|
|
Overall Study
Surgery cancelled
|
1
|
0
|
1
|
|
Overall Study
Insurance changed, standard of care visit not covered
|
0
|
0
|
1
|
Baseline Characteristics
Comparing Preoperative Injection of Mitomycin-C vs. Intraoperative Injection of Mitomycin-C vs. Topical Application of Mitomycin-C (Conventional Use) in Trabeculectomy
Baseline characteristics by cohort
| Measure |
Group A - Pre-operative Injection
n=7 eyes
Recieved a pre-operative injection of mitomycin-C prior to trabeculectomy
|
Group B - Intra-operative Injection
n=7 eyes
Recieved an intra-operative injection of mitomycin-C
|
Group C - Control
n=6 eyes
Recieved standard of care - topical application of mitomycin-C
|
Total
n=20 eyes
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
72.60 years
n=5 Participants
|
72.42 years
n=7 Participants
|
72.79 years
n=5 Participants
|
72.60 years
n=4 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
11 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
8 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
6 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
18 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
5 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
12 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Region of Enrollment
United States
|
6 participants
n=5 Participants
|
7 participants
n=7 Participants
|
6 participants
n=5 Participants
|
19 participants
n=4 Participants
|
|
Eye laterality
Right eye
|
3 eyes
n=32 eyes
|
4 eyes
n=16 eyes
|
3 eyes
n=48 eyes
|
10 eyes
n=42 eyes
|
|
Eye laterality
Left eye
|
4 eyes
n=32 eyes
|
3 eyes
n=16 eyes
|
3 eyes
n=48 eyes
|
10 eyes
n=42 eyes
|
PRIMARY outcome
Timeframe: 1 dayPopulation: All patients who had surgery and post-operative visits were included in analysis
Mean IOP at 1 day post-operatively
Outcome measures
| Measure |
Group A - Pre-operative Injection
n=5 eyes
Recieved a pre-operative injection of mitomycin-C prior to trabeculectomy
|
Group B - Intra-operative Injection
n=6 eyes
Recieved an intra-operative injection of mitomycin-C
|
Group C - Control
n=4 eyes
Recieved standard of care - topical application of mitomycin-C
|
|---|---|---|---|
|
IOP - 1 Day Postop
|
11.06 mm Hg
Standard Deviation 6.60
|
10.93 mm Hg
Standard Deviation 6.47
|
10.72 mm Hg
Standard Deviation 6.62
|
PRIMARY outcome
Timeframe: 1 weekPopulation: All patients who completed postop visit were included in analysis
Mean IOP at 1 week postop
Outcome measures
| Measure |
Group A - Pre-operative Injection
n=5 eyes
Recieved a pre-operative injection of mitomycin-C prior to trabeculectomy
|
Group B - Intra-operative Injection
n=4 eyes
Recieved an intra-operative injection of mitomycin-C
|
Group C - Control
n=5 eyes
Recieved standard of care - topical application of mitomycin-C
|
|---|---|---|---|
|
IOP - 1 Week Postop
|
11.20 mm Hg
Standard Deviation 4.49
|
9.13 mm Hg
Standard Deviation 4.13
|
24.1 mm Hg
Standard Deviation 8.11
|
PRIMARY outcome
Timeframe: 1 monthPopulation: All patients who completed postop visit were included in analysis
Mean IOP 1 month postoperatively
Outcome measures
| Measure |
Group A - Pre-operative Injection
n=5 eyes
Recieved a pre-operative injection of mitomycin-C prior to trabeculectomy
|
Group B - Intra-operative Injection
n=6 eyes
Recieved an intra-operative injection of mitomycin-C
|
Group C - Control
n=5 eyes
Recieved standard of care - topical application of mitomycin-C
|
|---|---|---|---|
|
IOP - 1 Month Postop
|
9.70 mm Hg
Standard Deviation 3.46
|
9.67 mm Hg
Standard Deviation 1.40
|
12.30 mm Hg
Standard Deviation 3.23
|
PRIMARY outcome
Timeframe: 3 monthsPopulation: All patients who completed postoperative visit were included in analysis
Mean IOP 3 months postoperatively
Outcome measures
| Measure |
Group A - Pre-operative Injection
n=5 eyes
Recieved a pre-operative injection of mitomycin-C prior to trabeculectomy
|
Group B - Intra-operative Injection
n=4 eyes
Recieved an intra-operative injection of mitomycin-C
|
Group C - Control
n=5 eyes
Recieved standard of care - topical application of mitomycin-C
|
|---|---|---|---|
|
IOP - 3 Months Postop
|
11.40 mm Hg
Standard Deviation 6.68
|
11.75 mm Hg
Standard Deviation 1.85
|
10.6 mm Hg
Standard Deviation 4.03
|
PRIMARY outcome
Timeframe: 6 monthsPopulation: All patients who completed postop visit were included in analysis
Mean IOP 6 months postoperatively
Outcome measures
| Measure |
Group A - Pre-operative Injection
n=3 eyes
Recieved a pre-operative injection of mitomycin-C prior to trabeculectomy
|
Group B - Intra-operative Injection
n=2 eyes
Recieved an intra-operative injection of mitomycin-C
|
Group C - Control
n=3 eyes
Recieved standard of care - topical application of mitomycin-C
|
|---|---|---|---|
|
IOP - 6 Months Postop
|
13.33 mm Hg
Standard Deviation 4.62
|
12 mm Hg
Standard Deviation 0
|
11.67 mm Hg
Standard Deviation 2.84
|
PRIMARY outcome
Timeframe: 12 monthsPopulation: All participants who completed visit were included in analysis
Mean IOP 12 months postoperatively
Outcome measures
| Measure |
Group A - Pre-operative Injection
n=3 eyes
Recieved a pre-operative injection of mitomycin-C prior to trabeculectomy
|
Group B - Intra-operative Injection
n=1 eyes
Recieved an intra-operative injection of mitomycin-C
|
Group C - Control
n=2 eyes
Recieved standard of care - topical application of mitomycin-C
|
|---|---|---|---|
|
IOP - 12 Months Postop
|
14.0 mm Hg
Standard Deviation 6
|
8 mm Hg
Standard Deviation NA
cannot calculate SD with only 1 value
|
10 mm Hg
Standard Deviation 0
|
Adverse Events
Group A - Pre-operative Injection
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Group B - Intra-operative Injection
Serious events: 1 serious events
Other events: 5 other events
Deaths: 0 deaths
Group C - Control
Serious events: 1 serious events
Other events: 3 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Group A - Pre-operative Injection
n=6 participants at risk
Recieved a pre-operative injection of mitomycin-C prior to trabeculectomy
|
Group B - Intra-operative Injection
n=7 participants at risk
Recieved an intra-operative injection of mitomycin-C
|
Group C - Control
n=6 participants at risk
Recieved standard of care - topical application of mitomycin-C
|
|---|---|---|---|
|
Gastrointestinal disorders
Lower GI Bleed
|
0.00%
0/6 • 12 months
|
0.00%
0/7 • 12 months
|
16.7%
1/6 • Number of events 1 • 12 months
|
|
Cardiac disorders
Acute decompensated heart failure
|
0.00%
0/6 • 12 months
|
14.3%
1/7 • Number of events 1 • 12 months
|
0.00%
0/6 • 12 months
|
Other adverse events
| Measure |
Group A - Pre-operative Injection
n=6 participants at risk
Recieved a pre-operative injection of mitomycin-C prior to trabeculectomy
|
Group B - Intra-operative Injection
n=7 participants at risk
Recieved an intra-operative injection of mitomycin-C
|
Group C - Control
n=6 participants at risk
Recieved standard of care - topical application of mitomycin-C
|
|---|---|---|---|
|
Eye disorders
Elevated intraocular pressure (IOP)
|
33.3%
2/6 • Number of events 5 • 12 months
|
57.1%
4/7 • Number of events 6 • 12 months
|
50.0%
3/6 • Number of events 8 • 12 months
|
|
Eye disorders
Hyphema
|
0.00%
0/6 • 12 months
|
14.3%
1/7 • Number of events 1 • 12 months
|
0.00%
0/6 • 12 months
|
|
Eye disorders
Bleb leak
|
16.7%
1/6 • Number of events 1 • 12 months
|
0.00%
0/7 • 12 months
|
0.00%
0/6 • 12 months
|
|
Eye disorders
Hypotony
|
0.00%
0/6 • 12 months
|
28.6%
2/7 • Number of events 2 • 12 months
|
0.00%
0/6 • 12 months
|
|
Eye disorders
Encapsulated bleb
|
0.00%
0/6 • 12 months
|
14.3%
1/7 • Number of events 2 • 12 months
|
0.00%
0/6 • 12 months
|
|
Eye disorders
Trace anterior chamber flare
|
16.7%
1/6 • Number of events 1 • 12 months
|
0.00%
0/7 • 12 months
|
0.00%
0/6 • 12 months
|
|
Eye disorders
Ocular pain
|
16.7%
1/6 • Number of events 1 • 12 months
|
0.00%
0/7 • 12 months
|
0.00%
0/6 • 12 months
|
|
Eye disorders
Subconjunctival hemorrhage
|
16.7%
1/6 • Number of events 1 • 12 months
|
0.00%
0/7 • 12 months
|
0.00%
0/6 • 12 months
|
|
Eye disorders
Disc hemorrhage
|
0.00%
0/6 • 12 months
|
28.6%
2/7 • Number of events 2 • 12 months
|
0.00%
0/6 • 12 months
|
|
Eye disorders
Bleb dysthesia
|
0.00%
0/6 • 12 months
|
14.3%
1/7 • Number of events 1 • 12 months
|
0.00%
0/6 • 12 months
|
|
Eye disorders
Cataract progression
|
0.00%
0/6 • 12 months
|
14.3%
1/7 • Number of events 1 • 12 months
|
16.7%
1/6 • Number of events 1 • 12 months
|
|
Eye disorders
Choroidal hemorrhage
|
0.00%
0/6 • 12 months
|
14.3%
1/7 • 12 months
|
0.00%
0/6 • 12 months
|
|
Eye disorders
Retinal detachment
|
0.00%
0/6 • 12 months
|
14.3%
1/7 • Number of events 1 • 12 months
|
0.00%
0/6 • 12 months
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place