Trial Outcomes & Findings for Study of OMNI Surgical System and iStent for Eyes With OAG (Trident) (NCT NCT04658095)
NCT ID: NCT04658095
Last Updated: 2025-10-27
Results Overview
Mean change in unmedicated DIOP from baseline at the 12-month postoperative examination is the mean of the difference between the baseline DIOP and the Month 12 DIOP for each subject. Baseline and Month 12 DIOP are measured after appropriate washout of any glaucoma medications.
Recruitment status
TERMINATED
Study phase
NA
Target enrollment
10 participants
Primary outcome timeframe
12 months
Results posted on
2025-10-27
Participant Flow
Participant milestones
| Measure |
Canaloplasty Only With the OMNI Surgical System
Subjects randomized to canaloplasty only with the OMNI surgical system
|
Canaloplasty + Trabeculotomy With the OMNI Surgical System
Subjects randomized to canaloplasty and trabeculotomy with OMNI
|
iStent Inject
Subjects randomized to iStent inject
|
|---|---|---|---|
|
Overall Study
STARTED
|
5
|
1
|
4
|
|
Overall Study
COMPLETED
|
0
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
5
|
1
|
4
|
Reasons for withdrawal
| Measure |
Canaloplasty Only With the OMNI Surgical System
Subjects randomized to canaloplasty only with the OMNI surgical system
|
Canaloplasty + Trabeculotomy With the OMNI Surgical System
Subjects randomized to canaloplasty and trabeculotomy with OMNI
|
iStent Inject
Subjects randomized to iStent inject
|
|---|---|---|---|
|
Overall Study
Study terminated
|
5
|
1
|
4
|
Baseline Characteristics
Study of OMNI Surgical System and iStent for Eyes With OAG (Trident)
Baseline characteristics by cohort
| Measure |
OMNI-Canaloplasty Only
n=5 Participants
All subjects for whom the OMNI (canaloplasty alone) is attempted
|
OMNI-canaloplasty + Trabeculotomy
n=1 Participants
All subjects for whom the OMNI (canaloplasty+trabeculotomy) is attempted
|
iStent Inject
n=4 Participants
All subjects for whom the iStent inject is attempted
|
Total
n=10 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
75.6 years
STANDARD_DEVIATION 3.5 • n=39 Participants
|
71 years
STANDARD_DEVIATION 0 • n=41 Participants
|
74.5 years
STANDARD_DEVIATION 5.1 • n=35 Participants
|
74.7 years
STANDARD_DEVIATION 4.0 • n=31 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
3 Participants
n=35 Participants
|
5 Participants
n=31 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=39 Participants
|
1 Participants
n=41 Participants
|
1 Participants
n=35 Participants
|
5 Participants
n=31 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
1 Participants
n=35 Participants
|
3 Participants
n=31 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
2 Participants
n=39 Participants
|
1 Participants
n=41 Participants
|
3 Participants
n=35 Participants
|
6 Participants
n=31 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
1 Participants
n=31 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
0 Participants
n=31 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
1 Participants
n=35 Participants
|
1 Participants
n=31 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
0 Participants
n=31 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
0 Participants
n=31 Participants
|
|
Race (NIH/OMB)
White
|
5 Participants
n=39 Participants
|
1 Participants
n=41 Participants
|
3 Participants
n=35 Participants
|
9 Participants
n=31 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
0 Participants
n=31 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
0 Participants
n=31 Participants
|
|
Region of Enrollment
United Kingdom
|
1 participants
n=39 Participants
|
0 participants
n=41 Participants
|
1 participants
n=35 Participants
|
2 participants
n=31 Participants
|
|
Region of Enrollment
Spain
|
4 participants
n=39 Participants
|
1 participants
n=41 Participants
|
2 participants
n=35 Participants
|
7 participants
n=31 Participants
|
|
Region of Enrollment
Poland
|
0 participants
n=39 Participants
|
0 participants
n=41 Participants
|
1 participants
n=35 Participants
|
1 participants
n=31 Participants
|
|
Diurnal IOP (DIOP)
|
29.0 mm Hg
STANDARD_DEVIATION 4.4 • n=39 Participants
|
26 mm Hg
STANDARD_DEVIATION 0 • n=41 Participants
|
24.3 mm Hg
STANDARD_DEVIATION 0.5 • n=35 Participants
|
26.8 mm Hg
STANDARD_DEVIATION 3.8 • n=31 Participants
|
PRIMARY outcome
Timeframe: 12 monthsPopulation: Results are not presented for this outcome as no subjects had reached the primary endpoint of Month 12 at the time of study termination.
Mean change in unmedicated DIOP from baseline at the 12-month postoperative examination is the mean of the difference between the baseline DIOP and the Month 12 DIOP for each subject. Baseline and Month 12 DIOP are measured after appropriate washout of any glaucoma medications.
Outcome measures
Outcome data not reported
Adverse Events
OMNI-canaloplasty Alone
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
OMNI-canaloplasty + Trabeculotomy
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
iStent Inject
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
OMNI-canaloplasty Alone
n=5 participants at risk
The safety analysis population will contain all subjects for whom the OMNI (canaloplasty alone) is attempted
|
OMNI-canaloplasty + Trabeculotomy
n=1 participants at risk
The safety analysis population will contain all subjects for whom the OMNI (canaloplasty+trabeculotomy) is attempted
|
iStent Inject
n=4 participants at risk
The safety analysis population will contain all subjects for whom the iStent injectis attempted
|
|---|---|---|---|
|
Eye disorders
IOP elevation
|
40.0%
2/5 • Number of events 2 • 6 months
|
0.00%
0/1 • 6 months
|
0.00%
0/4 • 6 months
|
|
Eye disorders
Anterior chamber inflammation
|
20.0%
1/5 • Number of events 1 • 6 months
|
0.00%
0/1 • 6 months
|
0.00%
0/4 • 6 months
|
|
Eye disorders
Allergic conjunctivitis
|
20.0%
1/5 • Number of events 1 • 6 months
|
0.00%
0/1 • 6 months
|
0.00%
0/4 • 6 months
|
|
General disorders
Tendinitis
|
20.0%
1/5 • Number of events 1 • 6 months
|
0.00%
0/1 • 6 months
|
0.00%
0/4 • 6 months
|
|
Respiratory, thoracic and mediastinal disorders
COVID-19 infection
|
20.0%
1/5 • Number of events 1 • 6 months
|
100.0%
1/1 • Number of events 1 • 6 months
|
0.00%
0/4 • 6 months
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee After Sponsor's publication of trial results, the Institution and Principal Investigator may publish the results of the Study generated by the Institution, subject to the obligations of the CTA, and prior approval of Sponsor in writing. The Institution shall furnish Sponsor with a written copy of any proposed publication or disclosure at least 60 days prior to submission for publication or disclosure. Sponsor may request changes or other measures to ensure the information is fairly stated.
- Publication restrictions are in place
Restriction type: OTHER