Trial Outcomes & Findings for The Effect of Sponge Versus No-Sponge Placement of Mitomycin-C on the Outcomes of Trabeculectomy With Ex-PRESS Glaucoma Filtration Device (NCT NCT02016898)
NCT ID: NCT02016898
Last Updated: 2018-02-09
Results Overview
To assess complication rates between patients who receive mitomycin-C using a sponge versus irrigation
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
100 participants
Primary outcome timeframe
post-operative day 1 to month 6
Results posted on
2018-02-09
Participant Flow
Two subjects were retroactively removed due to not satisfying the inclusion/exclusion criteria. An additional three subjects had uncertain group allocation due to clerical errors.
Participant milestones
| Measure |
Sponge Placement of Mitomycin-C
Randomization stratified by age (age ≥65 or age \< 65), baseline IOP (IOP ≥ 28 mmHg or IOP \< 28 mmHg), and concurrent cataract surgery.
Placement of the sponge
Mitomycin-C
|
Irrigation Placement of Mitomycin-C
Randomization stratified by age (age ≥65 or age \< 65), baseline IOP (IOP ≥ 28 mmHg or IOP \< 28 mmHg), and concurrent cataract surgery.
Irrigation placement
Mitomycin-C
|
|---|---|---|
|
Overall Study
STARTED
|
50
|
45
|
|
Overall Study
COMPLETED
|
45
|
40
|
|
Overall Study
NOT COMPLETED
|
5
|
5
|
Reasons for withdrawal
| Measure |
Sponge Placement of Mitomycin-C
Randomization stratified by age (age ≥65 or age \< 65), baseline IOP (IOP ≥ 28 mmHg or IOP \< 28 mmHg), and concurrent cataract surgery.
Placement of the sponge
Mitomycin-C
|
Irrigation Placement of Mitomycin-C
Randomization stratified by age (age ≥65 or age \< 65), baseline IOP (IOP ≥ 28 mmHg or IOP \< 28 mmHg), and concurrent cataract surgery.
Irrigation placement
Mitomycin-C
|
|---|---|---|
|
Overall Study
Death
|
1
|
1
|
|
Overall Study
Lost to Follow-up
|
4
|
4
|
Baseline Characteristics
The Effect of Sponge Versus No-Sponge Placement of Mitomycin-C on the Outcomes of Trabeculectomy With Ex-PRESS Glaucoma Filtration Device
Baseline characteristics by cohort
| Measure |
Sponge Placement of Mitomycin-C
n=50 Participants
Randomization will be stratified by age (age ≥65 or age \< 65), baseline IOP (IOP ≥ 28 mmHg or IOP \< 28 mmHg), and concurrent cataract surgery.
Placement of the sponge
Mitomycin-C
|
Irrigation Placement of Mitomycin-C
n=45 Participants
Randomization will be stratified by age (age ≥65 or age \< 65), baseline IOP (IOP ≥ 28 mmHg or IOP \< 28 mmHg), and concurrent cataract surgery.
Irrigation placement
Mitomycin-C
|
Total
n=95 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
68 years
STANDARD_DEVIATION 9.6 • n=5 Participants
|
73.1 years
STANDARD_DEVIATION 8.3 • n=7 Participants
|
70.4 years
STANDARD_DEVIATION 9.3 • n=5 Participants
|
|
Sex: Female, Male
Female
|
30 Participants
n=5 Participants
|
23 Participants
n=7 Participants
|
53 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
20 Participants
n=5 Participants
|
22 Participants
n=7 Participants
|
42 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
26 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
42 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
23 Participants
n=5 Participants
|
23 Participants
n=7 Participants
|
46 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
50 participants
n=5 Participants
|
45 participants
n=7 Participants
|
95 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: post-operative day 1 to month 6To assess complication rates between patients who receive mitomycin-C using a sponge versus irrigation
Outcome measures
| Measure |
Sponge Placement of Mitomycin-C
n=50 Participants
Randomization stratified by age (age ≥65 or age \< 65), baseline IOP (IOP ≥ 28 mmHg or IOP \< 28 mmHg), and concurrent cataract surgery.
Placement of the sponge
Mitomycin-C
|
Irrigation Placement of MMC
n=45 Participants
Randomization will be stratified by age (age ≥65 or age \< 65), baseline IOP (IOP ≥ 28 mmHg or IOP \< 28 mmHg), and concurrent cataract surgery.
Irrigation placement
Mitomycin-C
|
|---|---|---|
|
Complication Rates
|
29 Participants
|
28 Participants
|
SECONDARY outcome
Timeframe: post-operative day 1 to month 6Population: Five participants in each group were not included due to being lost to follow-up or deceased.
To assess final intraocular pressure lowering between patients who receive mitomycin-C using a sponge versus irrigation
Outcome measures
| Measure |
Sponge Placement of Mitomycin-C
n=45 Participants
Randomization stratified by age (age ≥65 or age \< 65), baseline IOP (IOP ≥ 28 mmHg or IOP \< 28 mmHg), and concurrent cataract surgery.
Placement of the sponge
Mitomycin-C
|
Irrigation Placement of MMC
n=40 Participants
Randomization will be stratified by age (age ≥65 or age \< 65), baseline IOP (IOP ≥ 28 mmHg or IOP \< 28 mmHg), and concurrent cataract surgery.
Irrigation placement
Mitomycin-C
|
|---|---|---|
|
Change in Intraocular Pressure
|
-8.4 mmHg (millimeters of mercury)
Standard Deviation 1.6
|
-8.2 mmHg (millimeters of mercury)
Standard Deviation 1.2
|
Adverse Events
Sponge Placement of Mitomycin-C
Serious events: 0 serious events
Other events: 29 other events
Deaths: 1 deaths
Irrigation Placement of Mitomycin-C
Serious events: 0 serious events
Other events: 28 other events
Deaths: 1 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Sponge Placement of Mitomycin-C
n=50 participants at risk
Randomization stratified by age (age ≥65 or age \< 65), baseline IOP (IOP ≥ 28 mmHg or IOP \< 28 mmHg), and concurrent cataract surgery.
Placement of the sponge
Mitomycin-C
|
Irrigation Placement of Mitomycin-C
n=45 participants at risk
Randomization stratified by age (age ≥65 or age \< 65), baseline IOP (IOP ≥ 28 mmHg or IOP \< 28 mmHg), and concurrent cataract surgery.
Irrigation placement
Mitomycin-C
|
|---|---|---|
|
Eye disorders
Cystic blebs
|
16.0%
8/50 • 6 months
|
11.1%
5/45 • 6 months
|
|
Eye disorders
Shallowing of anterior chamber
|
2.0%
1/50 • 6 months
|
6.7%
3/45 • 6 months
|
|
Eye disorders
Hypotony
|
10.0%
5/50 • 6 months
|
31.1%
14/45 • 6 months
|
|
Eye disorders
Choroidal effusion
|
6.0%
3/50 • 6 months
|
6.7%
3/45 • 6 months
|
|
Eye disorders
Suprachoroidal hemorrhage
|
0.00%
0/50 • 6 months
|
2.2%
1/45 • 6 months
|
|
Eye disorders
Hyphema
|
2.0%
1/50 • 6 months
|
2.2%
1/45 • 6 months
|
|
Eye disorders
Wound leak
|
36.0%
18/50 • 6 months
|
31.1%
14/45 • 6 months
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place