Trial Outcomes & Findings for Subconjunctival Versus Direct Mitomycin C in Trabeculectomy (NCT NCT04352660)
NCT ID: NCT04352660
Last Updated: 2020-07-02
Results Overview
Percentage of patients achieving at least a 30% mean intraocular pressure reductions from baseline and with an intraocular pressure \<21 mm Hg. Subjects that met this criteria without the use of intraocular pressure lowering medications were classified as "Complete Success." Subjects that met this criteria but required the use of intraocular pressure lowering medications were classified as "Qualified Success." Subjects that failed to meet this criteria were classified as "Failure." Subjects that failed to meet this criteria and required additional glaucoma surgery were classified as "Complete Failure."
COMPLETED
PHASE4
100 participants
6 months
2020-07-02
Participant Flow
Participant milestones
| Measure |
Injection Group
MMC delivered by preoperative subconjunctival injection
Mitomycin-C injection: MMC delivered by preoperative subconjunctival injection
|
Sponge Group
MMC delivered by intraoperative direct scleral application with impregnated cellulose sponges
Mitomycin-C sponge: MMC delivered by intraoperative direct scleral application with impregnated cellulose sponges
|
|---|---|---|
|
Overall Study
STARTED
|
50
|
50
|
|
Overall Study
COMPLETED
|
36
|
40
|
|
Overall Study
NOT COMPLETED
|
14
|
10
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Subconjunctival Versus Direct Mitomycin C in Trabeculectomy
Baseline characteristics by cohort
| Measure |
Injection Group
n=50 Participants
MMC delivered by preoperative subconjunctival injection
Mitomycin-C injection: MMC delivered by preoperative subconjunctival injection
|
Sponge Group
n=50 Participants
MMC delivered by intraoperative direct scleral application with impregnated cellulose sponges
Mitomycin-C sponge: MMC delivered by intraoperative direct scleral application with impregnated cellulose sponges
|
Total
n=100 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
69.9 years
STANDARD_DEVIATION 13.4 • n=93 Participants
|
74.2 years
STANDARD_DEVIATION 9.5 • n=4 Participants
|
72.0 years
STANDARD_DEVIATION 11.6 • n=27 Participants
|
|
Sex: Female, Male
Female
|
26 Participants
n=93 Participants
|
24 Participants
n=4 Participants
|
50 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
24 Participants
n=93 Participants
|
26 Participants
n=4 Participants
|
50 Participants
n=27 Participants
|
|
Race/Ethnicity, Customized
White
|
27 Participants
n=93 Participants
|
28 Participants
n=4 Participants
|
55 Participants
n=27 Participants
|
|
Race/Ethnicity, Customized
Asian
|
9 Participants
n=93 Participants
|
7 Participants
n=4 Participants
|
16 Participants
n=27 Participants
|
|
Race/Ethnicity, Customized
Hispanic
|
9 Participants
n=93 Participants
|
5 Participants
n=4 Participants
|
14 Participants
n=27 Participants
|
|
Race/Ethnicity, Customized
Black
|
2 Participants
n=93 Participants
|
3 Participants
n=4 Participants
|
5 Participants
n=27 Participants
|
|
Race/Ethnicity, Customized
Other
|
3 Participants
n=93 Participants
|
7 Participants
n=4 Participants
|
10 Participants
n=27 Participants
|
|
Diagnosis
Primary open angle glaucoma
|
45 Participants
n=93 Participants
|
43 Participants
n=4 Participants
|
88 Participants
n=27 Participants
|
|
Diagnosis
Pseudoexfoliation glaucoma
|
2 Participants
n=93 Participants
|
3 Participants
n=4 Participants
|
5 Participants
n=27 Participants
|
|
Diagnosis
Pigmentary glaucoma
|
0 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
|
Diagnosis
Chronic angle closure glaucoma
|
1 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
|
Diagnosis
Other
|
2 Participants
n=93 Participants
|
3 Participants
n=4 Participants
|
5 Participants
n=27 Participants
|
|
Visual Acuity
|
0.31 logMAR
STANDARD_DEVIATION 0.34 • n=93 Participants
|
0.36 logMAR
STANDARD_DEVIATION 0.52 • n=4 Participants
|
0.335 logMAR
STANDARD_DEVIATION 0.44 • n=27 Participants
|
|
Preoperative Visual Field Mean Deviation
|
-17.19 decibels
STANDARD_DEVIATION 7.90 • n=93 Participants
|
-15.87 decibels
STANDARD_DEVIATION 8.09 • n=4 Participants
|
-16.53 decibels
STANDARD_DEVIATION 8.00 • n=27 Participants
|
|
Preoperative Pattern Standard Deviation
|
9.4 decibels
STANDARD_DEVIATION 3.6 • n=93 Participants
|
8.9 decibels
STANDARD_DEVIATION 3.2 • n=4 Participants
|
9.15 decibels
STANDARD_DEVIATION 3.40 • n=27 Participants
|
|
Preoperative Intraocular Pressure
|
21.1 mm Hg
STANDARD_DEVIATION 7.2 • n=93 Participants
|
21.8 mm Hg
STANDARD_DEVIATION 9.3 • n=4 Participants
|
21.45 mm Hg
STANDARD_DEVIATION 8.3 • n=27 Participants
|
|
IOP Goal
|
11.8 mm Hg
STANDARD_DEVIATION 0.9 • n=93 Participants
|
12.7 mm Hg
STANDARD_DEVIATION 2.2 • n=4 Participants
|
12.2 mm Hg
STANDARD_DEVIATION 1.7 • n=27 Participants
|
|
Number of Medications
None
|
0 Participants
n=93 Participants
|
4 Participants
n=4 Participants
|
4 Participants
n=27 Participants
|
|
Number of Medications
1
|
4 Participants
n=93 Participants
|
6 Participants
n=4 Participants
|
10 Participants
n=27 Participants
|
|
Number of Medications
2
|
6 Participants
n=93 Participants
|
12 Participants
n=4 Participants
|
18 Participants
n=27 Participants
|
|
Number of Medications
3
|
21 Participants
n=93 Participants
|
21 Participants
n=4 Participants
|
42 Participants
n=27 Participants
|
|
Number of Medications
4
|
17 Participants
n=93 Participants
|
7 Participants
n=4 Participants
|
24 Participants
n=27 Participants
|
|
Number of Medications
5
|
2 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
2 Participants
n=27 Participants
|
PRIMARY outcome
Timeframe: 6 monthsPopulation: 14 subjects in the Injection group were lost to follow up at the 6 month postoperative visit. 10 subjects from the Sponge group were lost to follow up at the 6 month postoperative visit.
Percentage of patients achieving at least a 30% mean intraocular pressure reductions from baseline and with an intraocular pressure \<21 mm Hg. Subjects that met this criteria without the use of intraocular pressure lowering medications were classified as "Complete Success." Subjects that met this criteria but required the use of intraocular pressure lowering medications were classified as "Qualified Success." Subjects that failed to meet this criteria were classified as "Failure." Subjects that failed to meet this criteria and required additional glaucoma surgery were classified as "Complete Failure."
Outcome measures
| Measure |
Injection Group
n=36 Participants
MMC delivered by preoperative subconjunctival injection
Mitomycin-C injection: MMC delivered by preoperative subconjunctival injection
|
Sponge Group
n=40 Participants
MMC delivered by intraoperative direct scleral application with impregnated cellulose sponges
Mitomycin-C sponge: MMC delivered by intraoperative direct scleral application with impregnated cellulose sponges
|
|---|---|---|
|
Percentage of Participants Achieving Intraocular Pressure Reduction Thresholds
Complete Success
|
21 Participants
|
21 Participants
|
|
Percentage of Participants Achieving Intraocular Pressure Reduction Thresholds
Qualified Success
|
1 Participants
|
3 Participants
|
|
Percentage of Participants Achieving Intraocular Pressure Reduction Thresholds
Failure
|
6 Participants
|
9 Participants
|
|
Percentage of Participants Achieving Intraocular Pressure Reduction Thresholds
Complete Failure
|
8 Participants
|
7 Participants
|
SECONDARY outcome
Timeframe: 6 monthsPopulation: In the injection group, 14 subjects were lost to follow up and 17 subjects did not undergo bleb assessments at 6 months.In the sponge group, 10 subjects were lost to follow up and 20 subjects did not undergo bleb assessments at 6 months.
Bleb morphology at 6 months was graded using Indiana Bleb Appearance Grading Scale. Bleb height was graded on a scale of 0 to 3 (0: flat bleb without visible elevation, 1: low bleb elevation, 2: moderate bleb elevation, 3: high bleb elevation). Bleb extent was graded on a scale of 0 to 3 (0: no visible bleb extent to less than 1 clock hour, 1: extent equal to or greater than 1 clock hour but less than 2 clock hours, 2: extent equal to or greater than 2 clock hours but less than 4 clock hours, 3: extent equal to or greater than 4 clock hours). Bleb vascularity was graded on a scale of 0 to 4 (0: avascular/white, 1: avascular/cystic, 2: mild vascularity, 3: moderate vascularity, 4: extensive vascularity). Scales are descriptive and do not necessarily represent better or worse outcomes.
Outcome measures
| Measure |
Injection Group
n=19 Participants
MMC delivered by preoperative subconjunctival injection
Mitomycin-C injection: MMC delivered by preoperative subconjunctival injection
|
Sponge Group
n=20 Participants
MMC delivered by intraoperative direct scleral application with impregnated cellulose sponges
Mitomycin-C sponge: MMC delivered by intraoperative direct scleral application with impregnated cellulose sponges
|
|---|---|---|
|
Bleb Morphology
Height
|
1.6 scores on a scale
Interval 1.3 to 1.9
|
1.7 scores on a scale
Interval 1.4 to 1.9
|
|
Bleb Morphology
Extent
|
2.2 scores on a scale
Interval 1.9 to 2.5
|
2.0 scores on a scale
Interval 1.7 to 2.3
|
|
Bleb Morphology
Vascularity
|
1.5 scores on a scale
Interval 1.2 to 1.9
|
1.5 scores on a scale
Interval 1.2 to 1.8
|
SECONDARY outcome
Timeframe: 6 monthsPopulation: In the injection group, 14 subjects were lost to follow up and 1 subject did not have medications documented at 6 months. In the sponge group, 10 subjects were lost to follow up and 2 subjects did not have medications documented at 6 months.
Number of intraocular pressure lowering medications used by the patient at follow up visit.
Outcome measures
| Measure |
Injection Group
n=35 Participants
MMC delivered by preoperative subconjunctival injection
Mitomycin-C injection: MMC delivered by preoperative subconjunctival injection
|
Sponge Group
n=38 Participants
MMC delivered by intraoperative direct scleral application with impregnated cellulose sponges
Mitomycin-C sponge: MMC delivered by intraoperative direct scleral application with impregnated cellulose sponges
|
|---|---|---|
|
Medications
0
|
30 Participants
|
32 Participants
|
|
Medications
1
|
3 Participants
|
4 Participants
|
|
Medications
2
|
1 Participants
|
1 Participants
|
|
Medications
3
|
1 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: 6 monthsPopulation: In the injection group, 14 subjects were lost to follow up at 6 months. In the sponge group, 10 subjects were lost to follow up at 6 months.
Change in visual acuity from baseline
Outcome measures
| Measure |
Injection Group
n=36 Participants
MMC delivered by preoperative subconjunctival injection
Mitomycin-C injection: MMC delivered by preoperative subconjunctival injection
|
Sponge Group
n=40 Participants
MMC delivered by intraoperative direct scleral application with impregnated cellulose sponges
Mitomycin-C sponge: MMC delivered by intraoperative direct scleral application with impregnated cellulose sponges
|
|---|---|---|
|
Visual Acuity
|
0.11 logMAR
Interval 0.0 to 0.22
|
0.03 logMAR
Interval -0.09 to 0.14
|
SECONDARY outcome
Timeframe: 6 monthsNumber of eyes that experienced surgical complications following surgery
Outcome measures
| Measure |
Injection Group
n=50 Participants
MMC delivered by preoperative subconjunctival injection
Mitomycin-C injection: MMC delivered by preoperative subconjunctival injection
|
Sponge Group
n=50 Participants
MMC delivered by intraoperative direct scleral application with impregnated cellulose sponges
Mitomycin-C sponge: MMC delivered by intraoperative direct scleral application with impregnated cellulose sponges
|
|---|---|---|
|
Number of Participants With Surgical Complications
Hypotony Maculopathy
|
3 participants
|
1 participants
|
|
Number of Participants With Surgical Complications
Choroidal Effusions
|
2 participants
|
5 participants
|
SECONDARY outcome
Timeframe: 6 monthsNumber of eyes requiring additional surgery from each group
Outcome measures
| Measure |
Injection Group
n=50 Participants
MMC delivered by preoperative subconjunctival injection
Mitomycin-C injection: MMC delivered by preoperative subconjunctival injection
|
Sponge Group
n=50 Participants
MMC delivered by intraoperative direct scleral application with impregnated cellulose sponges
Mitomycin-C sponge: MMC delivered by intraoperative direct scleral application with impregnated cellulose sponges
|
|---|---|---|
|
Number of Participants Requiring Additional Surgery
Trab Revision
|
8 participants
|
5 participants
|
|
Number of Participants Requiring Additional Surgery
GDD
|
2 participants
|
1 participants
|
|
Number of Participants Requiring Additional Surgery
Xen
|
0 participants
|
1 participants
|
|
Number of Participants Requiring Additional Surgery
Trabectome
|
0 participants
|
1 participants
|
|
Number of Participants Requiring Additional Surgery
Any Surgery
|
8 participants
|
7 participants
|
|
Number of Participants Requiring Additional Surgery
CEIOL
|
8 participants
|
5 participants
|
|
Number of Participants Requiring Additional Surgery
YAG
|
0 participants
|
1 participants
|
SECONDARY outcome
Timeframe: 6 monthsMean number of postoperative interventions (needling, antifibrotic injections) performed in each group
Outcome measures
| Measure |
Injection Group
n=50 Participants
MMC delivered by preoperative subconjunctival injection
Mitomycin-C injection: MMC delivered by preoperative subconjunctival injection
|
Sponge Group
n=50 Participants
MMC delivered by intraoperative direct scleral application with impregnated cellulose sponges
Mitomycin-C sponge: MMC delivered by intraoperative direct scleral application with impregnated cellulose sponges
|
|---|---|---|
|
Postoperative Interventions
Laser suture lysis
|
2.0 number of procedures
Interval 1.5 to 2.5
|
1.6 number of procedures
Interval 1.1 to 2.1
|
|
Postoperative Interventions
5FU Injection
|
3.3 number of procedures
Interval 2.6 to 4.0
|
3.2 number of procedures
Interval 2.2 to 4.3
|
Adverse Events
Injection Group
Sponge Group
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Injection Group
n=50 participants at risk
MMC delivered by preoperative subconjunctival injection
Mitomycin-C injection: MMC delivered by preoperative subconjunctival injection
|
Sponge Group
n=50 participants at risk
MMC delivered by intraoperative direct scleral application with impregnated cellulose sponges
Mitomycin-C sponge: MMC delivered by intraoperative direct scleral application with impregnated cellulose sponges
|
|---|---|---|
|
Eye disorders
Hypotony maculopathy
|
6.0%
3/50 • 6 months
|
2.0%
1/50 • 6 months
|
|
Eye disorders
Choroidal effusions
|
4.0%
2/50 • 6 months
|
10.0%
5/50 • 6 months
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place