Trial Outcomes & Findings for A Prospective, Multicenter Study of the OMNI® Surgical System in Pseudophakic Eyes With Open Angle Glaucoma (NCT NCT04465630)
NCT ID: NCT04465630
Last Updated: 2022-06-28
Results Overview
Change in unmedicated mean diurnal IOP (DIOP) for subjects who reached the 6-month post-operative timepoint by the time of study closure
Recruitment status
TERMINATED
Study phase
NA
Target enrollment
78 participants
Primary outcome timeframe
6 months
Results posted on
2022-06-28
Participant Flow
The enrollment period for the study lasted 7 months and the study included 11 sites across the USA
Participant milestones
| Measure |
Pseudophakic Eyes With Open Angle Glaucoma
One eye of each eligible subject enrolled in the trial will receive surgery for Open Angle Glaucoma using the OMNI® Surgical System.
OMNI® Surgical System: Ab-interno transluminal viscoelastic delivery and trabeculotomy performed with the OMNI Surgical System
|
|---|---|
|
Overall Study
STARTED
|
78
|
|
Overall Study
COMPLETED
|
0
|
|
Overall Study
NOT COMPLETED
|
78
|
Reasons for withdrawal
| Measure |
Pseudophakic Eyes With Open Angle Glaucoma
One eye of each eligible subject enrolled in the trial will receive surgery for Open Angle Glaucoma using the OMNI® Surgical System.
OMNI® Surgical System: Ab-interno transluminal viscoelastic delivery and trabeculotomy performed with the OMNI Surgical System
|
|---|---|
|
Overall Study
Sponsor Decision to terminate the study
|
54
|
|
Overall Study
Screen failure
|
8
|
|
Overall Study
Baseline failure
|
16
|
Baseline Characteristics
A Prospective, Multicenter Study of the OMNI® Surgical System in Pseudophakic Eyes With Open Angle Glaucoma
Baseline characteristics by cohort
| Measure |
Pseudophakic Eyes With Open Angle Glaucoma
n=54 Participants
Eligible subjects enrolled in the trial will receive surgery for Open Angle Glaucoma using the OMNI® Surgical System.
OMNI® Surgical System: Ab-interno transluminal viscoelastic delivery and trabeculotomy performed with the OMNI Surgical System
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
9 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
45 Participants
n=5 Participants
|
|
Age, Continuous
|
73.2 years
STANDARD_DEVIATION 7.6 • n=5 Participants
|
|
Sex: Female, Male
Female
|
35 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
19 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
51 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
54 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 6 monthsPopulation: Overall mean change in IOP from baseline for subjects who reached the 6-month time point by study closure
Change in unmedicated mean diurnal IOP (DIOP) for subjects who reached the 6-month post-operative timepoint by the time of study closure
Outcome measures
| Measure |
Pseudophakic Eyes With Open Angle Glaucoma
n=14 Participants
One eye of each eligible subjects enrolled in the trial will receive surgery for Open Angle Glaucoma using the OMNI® Surgical System.
OMNI® Surgical System: Ab-interno transluminal viscoelastic delivery and trabeculotomy performed with the OMNI Surgical System
|
|---|---|
|
Change in Intraocular Pressure (IOP)
|
-8.8 mmHg
Standard Deviation 7.3
|
SECONDARY outcome
Timeframe: 6 monthsPopulation: Overall mean change in number of ocular hypotensive medications from Screening for enrolled subjects who reached the 6-month post-operative time point at the time of study closure
Change in the number of ocular hypotensive medications between screening and 6 months for subjects who reached the 6-month post-operative timepoint by the time of study closure
Outcome measures
| Measure |
Pseudophakic Eyes With Open Angle Glaucoma
n=14 Participants
One eye of each eligible subjects enrolled in the trial will receive surgery for Open Angle Glaucoma using the OMNI® Surgical System.
OMNI® Surgical System: Ab-interno transluminal viscoelastic delivery and trabeculotomy performed with the OMNI Surgical System
|
|---|---|
|
Change in Number of Medications
|
-1.2 number of hypotensive medications
Standard Deviation 1.3
|
Adverse Events
Pseudophakic Eyes With Open Angle Glaucoma
Serious events: 2 serious events
Other events: 20 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Pseudophakic Eyes With Open Angle Glaucoma
n=78 participants at risk
Eligible subjects enrolled in the trial will receive surgery for Open Angle Glaucoma using the OMNI® Surgical System.
OMNI® Surgical System: Ab-interno transluminal viscoelastic delivery and trabeculotomy performed with the OMNI Surgical System
|
|---|---|
|
Renal and urinary disorders
Renal Failure (unrelated)
|
1.3%
1/78 • Number of events 1 • 6 months
|
|
Cardiac disorders
Coronary Artery Disease (unrelated)
|
1.3%
1/78 • Number of events 1 • 6 months
|
Other adverse events
| Measure |
Pseudophakic Eyes With Open Angle Glaucoma
n=78 participants at risk
Eligible subjects enrolled in the trial will receive surgery for Open Angle Glaucoma using the OMNI® Surgical System.
OMNI® Surgical System: Ab-interno transluminal viscoelastic delivery and trabeculotomy performed with the OMNI Surgical System
|
|---|---|
|
Respiratory, thoracic and mediastinal disorders
COVID-19 (unrelated)
|
1.3%
1/78 • Number of events 1 • 6 months
|
|
Eye disorders
Vitreous Hemorrhage (unrelated)
|
1.3%
1/78 • Number of events 1 • 6 months
|
|
Eye disorders
Iris Prolapse (unrelated)
|
1.3%
1/78 • Number of events 1 • 6 months
|
|
Eye disorders
Posterior Capsular Opacification (unrelated)
|
1.3%
1/78 • Number of events 1 • 6 months
|
|
Eye disorders
Corneal edema after 1 week
|
1.3%
1/78 • Number of events 1 • 6 months
|
|
Eye disorders
Layered hyphema greater than or equal to 1mm (unrelated)
|
3.8%
3/78 • Number of events 3 • 6 months
|
|
Eye disorders
Clinically significant cystoid macular edema (unrelated)
|
1.3%
1/78 • Number of events 1 • 6 months
|
|
Eye disorders
IOP increase of 10 mmHg above baseline IOP at 1 month or later
|
1.3%
1/78 • Number of events 1 • 6 months
|
|
Eye disorders
Benign paroxysmal positional vertigo (unrelated)
|
1.3%
1/78 • Number of events 1 • 6 months
|
|
Eye disorders
Blepharitis (unrelated)
|
1.3%
1/78 • Number of events 1 • 6 months
|
|
Eye disorders
Eye pain
|
1.3%
1/78 • Number of events 1 • 6 months
|
|
Eye disorders
Headache (unrelated)
|
1.3%
1/78 • Number of events 1 • 6 months
|
|
Eye disorders
Headache above left eye (unrelated)
|
1.3%
1/78 • Number of events 1 • 6 months
|
|
Eye disorders
Iris atrophy (unrelated)
|
1.3%
1/78 • Number of events 1 • 6 months
|
|
Eye disorders
Iris prolapse (unrelated)
|
1.3%
1/78 • Number of events 1 • 6 months
|
|
Eye disorders
Macular edema (unrelated)
|
1.3%
1/78 • Number of events 1 • 6 months
|
|
Eye disorders
Small blood clots in trabecular meshwork (unrelated)
|
1.3%
1/78 • Number of events 1 • 6 months
|
|
Eye disorders
Superficial punctate keratitis (unrelated)
|
1.3%
1/78 • Number of events 1 • 6 months
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Depending on certain terms described in the agreement, the Institution and Principal Investigator may publish the results of the Study generated by the Institution, subject to...the prior approval of Sponsor in writing. The Institution shall furnish Sponsor with a written copy of any proposed publication or disclosure,...at least sixty (60) days prior to submission for publication or disclosure.
- Publication restrictions are in place
Restriction type: OTHER