Trial Outcomes & Findings for Prospective Randomized Study Comparing Ex-PRESS to Trabeculectomy (NCT NCT01263561)
NCT ID: NCT01263561
Last Updated: 2014-12-09
Results Overview
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
64 participants
Primary outcome timeframe
1 year post surgery
Results posted on
2014-12-09
Participant Flow
Participant milestones
| Measure |
Trabeculectomy
trabeculectomy filtering surgery
trabeculectomy: trabeculectomy filtering surgery
|
ExPRESS
ExPRESS miniature glaucoma drainage device
ExPRESS shunt: ExPRESS miniature glaucoma drainage device
|
|---|---|---|
|
Overall Study
STARTED
|
31
|
33
|
|
Overall Study
COMPLETED
|
30
|
31
|
|
Overall Study
NOT COMPLETED
|
1
|
2
|
Reasons for withdrawal
| Measure |
Trabeculectomy
trabeculectomy filtering surgery
trabeculectomy: trabeculectomy filtering surgery
|
ExPRESS
ExPRESS miniature glaucoma drainage device
ExPRESS shunt: ExPRESS miniature glaucoma drainage device
|
|---|---|---|
|
Overall Study
Death
|
1
|
2
|
Baseline Characteristics
Prospective Randomized Study Comparing Ex-PRESS to Trabeculectomy
Baseline characteristics by cohort
| Measure |
Trabeculectomy
n=31 Participants
trabeculectomy filtering surgery
trabeculectomy: trabeculectomy filtering surgery
|
ExPRESS
n=33 Participants
ExPRESS miniature glaucoma drainage device
ExPRESS shunt: ExPRESS miniature glaucoma drainage device
|
Total
n=64 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
65.9 years
STANDARD_DEVIATION 11.5 • n=5 Participants
|
62 years
STANDARD_DEVIATION 13.9 • n=7 Participants
|
63.9 years
STANDARD_DEVIATION 12.7 • n=5 Participants
|
|
Sex: Female, Male
Female
|
10 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
23 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
21 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
41 Participants
n=5 Participants
|
|
intraocular pressure
|
22 mmHg
STANDARD_DEVIATION 6.8 • n=5 Participants
|
22.6 mmHg
STANDARD_DEVIATION 10.2 • n=7 Participants
|
22.3 mmHg
STANDARD_DEVIATION 8.6 • n=5 Participants
|
|
glaucoma medications
|
3.4 number of medications
STANDARD_DEVIATION 1.3 • n=5 Participants
|
3.5 number of medications
STANDARD_DEVIATION .9 • n=7 Participants
|
3.5 number of medications
STANDARD_DEVIATION 1.1 • n=5 Participants
|
|
visual acuity
|
.48 logMAR
STANDARD_DEVIATION .6 • n=5 Participants
|
.42 logMAR
STANDARD_DEVIATION .6 • n=7 Participants
|
.44 logMAR
STANDARD_DEVIATION .56 • n=5 Participants
|
PRIMARY outcome
Timeframe: 1 year post surgeryOutcome measures
| Measure |
Trabeculectomy
n=30 Participants
trabeculectomy filtering surgery
trabeculectomy: trabeculectomy filtering surgery
|
ExPRESS
n=31 Participants
ExPRESS miniature glaucoma drainage device
ExPRESS shunt: ExPRESS miniature glaucoma drainage device
|
|---|---|---|
|
Intraocular Pressure
|
10.7 mmHg
Standard Deviation 3.5
|
11.2 mmHg
Standard Deviation 4.3
|
PRIMARY outcome
Timeframe: 1 year post surgeryOutcome measures
| Measure |
Trabeculectomy
n=30 Participants
trabeculectomy filtering surgery
trabeculectomy: trabeculectomy filtering surgery
|
ExPRESS
n=31 Participants
ExPRESS miniature glaucoma drainage device
ExPRESS shunt: ExPRESS miniature glaucoma drainage device
|
|---|---|---|
|
Success Rate (IOP Between 5-18 mmHg and 20% Reduction From Baseline) Without Glaucoma Medication
|
57 percentage of participants
|
71 percentage of participants
|
SECONDARY outcome
Timeframe: 1 year post surgeryComplications will be evaluated for the intra-operative, early post-operative (up until 1 month) and late post-operative (from 1 month to 1 year) periods. In addition complications will be evaluated as severe (defined as a permanent reduction in vision or complications requiring a surgical intervention) and not severe (complications which resolve with conservative management). As an individual subject may have more than one complication, the number of complications will be compared between the two surgical groups.
Outcome measures
| Measure |
Trabeculectomy
n=31 Participants
trabeculectomy filtering surgery
trabeculectomy: trabeculectomy filtering surgery
|
ExPRESS
n=33 Participants
ExPRESS miniature glaucoma drainage device
ExPRESS shunt: ExPRESS miniature glaucoma drainage device
|
|---|---|---|
|
Complications
choroidal effusion
|
1 participants
|
0 participants
|
|
Complications
early bleb leak
|
2 participants
|
3 participants
|
|
Complications
ExPRESS eroding through sclera
|
0 participants
|
1 participants
|
|
Complications
membrane over ExPRESS
|
0 participants
|
1 participants
|
|
Complications
Total # of subjects with a complication
|
16 participants
|
15 participants
|
|
Complications
Late transient hypotony
|
2 participants
|
3 participants
|
|
Complications
encapsulated bleb
|
1 participants
|
0 participants
|
|
Complications
Early transient hypotony
|
12 participants
|
13 participants
|
Adverse Events
Trabeculectomy
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
ExPRESS
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
Dr Yvonne Buys
Department of Ophthalmology and Vision Sciences, University of Toronto
Phone: 416-603-5682
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place