Trial Outcomes & Findings for Comparing NGENUITY vs Conventional Microscope in a New Hydrus User (NCT NCT05529966)
NCT ID: NCT05529966
Last Updated: 2025-04-17
Results Overview
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
32 participants
Primary outcome timeframe
up to 1 hour
Results posted on
2025-04-17
Participant Flow
32 participants signed informed consent, 28 were randomized to either study arm.
Unit of analysis: Eyes
Participant milestones
| Measure |
Conventional Microscope
Participants randomized to the use of a conventional microscope for the first eye procedure. Participants who had a procedure for their second eye were randomized again to either the conventional or NGENUITY microscope.
|
NGENUITY
Participants randomized to the use of a NGENUITY microscope for the first eye procedure. Participants who had a procedure for their second eye were randomized again to either the conventional or NGENUITY microscope.
|
Conventional Microscope (Re-randomized)
Participants who had a procedure for their second eye were re-randomized to use of a conventional microscope for the procedure.
|
NGENUITY (Re-randomized)
Participants who had a procedure for their second eye were re-randomized to use of the NGENUITY microscope for the procedure.
|
|---|---|---|---|---|
|
First Eye
STARTED
|
14 14
|
14 14
|
0 0
|
0 0
|
|
First Eye
Stent Placement Could Not be Performed
|
1 1
|
1 1
|
0 0
|
0 0
|
|
First Eye
Had Missing Data
|
1 1
|
0 0
|
0 0
|
0 0
|
|
First Eye
Evaluable for Primary and Secondary Outcome Measure Analysis
|
12 12
|
13 13
|
0 0
|
0 0
|
|
First Eye
COMPLETED
|
13 13
|
13 13
|
0 0
|
0 0
|
|
First Eye
NOT COMPLETED
|
1 1
|
1 1
|
0 0
|
0 0
|
|
Second Eye
STARTED
|
0 0
|
0 0
|
1 1
|
3 3
|
|
Second Eye
Randomized to Use of Opposite Microscope for Second Eye Procedure
|
0 0
|
0 0
|
1 1
|
2 2
|
|
Second Eye
Evaluable for Primary and Secondary Outcome Measure Analysis
|
0 0
|
0 0
|
1 1
|
3 3
|
|
Second Eye
COMPLETED
|
0 0
|
0 0
|
1 1
|
3 3
|
|
Second Eye
NOT COMPLETED
|
0 0
|
0 0
|
0 0
|
0 0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Comparing NGENUITY vs Conventional Microscope in a New Hydrus User
Baseline characteristics by cohort
| Measure |
Conventional Microscope
n=12 Participants
Participants randomized to the use of a conventional microscope for the first eye procedure. Participants who had a procedure for their second eye were randomized again to either the conventional or NGENUITY microscope.
|
NGENUITY
n=13 Participants
Participants randomized to the use of a NGENUITY microscope for the first eye procedure. Participants who had a procedure for their second eye were randomized again to either the conventional or NGENUITY microscope.
|
Total
n=25 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
75.6 years
STANDARD_DEVIATION 8.1 • n=99 Participants
|
76.1 years
STANDARD_DEVIATION 7.3 • n=107 Participants
|
75.9 years
STANDARD_DEVIATION 7.5 • n=206 Participants
|
|
Sex: Female, Male
Female
|
7 Participants
n=99 Participants
|
6 Participants
n=107 Participants
|
13 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=99 Participants
|
7 Participants
n=107 Participants
|
12 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
12 Participants
n=99 Participants
|
12 Participants
n=107 Participants
|
24 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
American Indian
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Asian
|
6 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
8 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Black
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Other
|
2 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
White
|
4 Participants
n=99 Participants
|
9 Participants
n=107 Participants
|
13 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
12 Participants
n=99 Participants
|
13 Participants
n=107 Participants
|
25 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: up to 1 hourPopulation: Participants/eyes evaluable for primary and secondary outcome measure analysis
Outcome measures
| Measure |
Conventional Microscope
n=13 Eyes
Conventional microscope used during micro-stent placement.
|
NGENUITY
n=16 Eyes
NGENUITY microscope used during micro-stent placement.
|
|---|---|---|
|
Time of First Cannula in Until Satisfactory Stent Placement and Cannula Out
|
2.55 minutes
Standard Deviation 1.36
|
3.06 minutes
Standard Deviation 2.17
|
SECONDARY outcome
Timeframe: up to 1 hourPopulation: Participants/eyes evaluable for primary and secondary outcome measure analysis
Outcome measures
| Measure |
Conventional Microscope
n=13 Eyes
Conventional microscope used during micro-stent placement.
|
NGENUITY
n=16 Eyes
NGENUITY microscope used during micro-stent placement.
|
|---|---|---|
|
Number of Trabecular Meshwork Piercing Attempts Needed to Place Stent
|
1.50 piercing
Standard Deviation 0.94
|
1.53 piercing
Standard Deviation 0.92
|
SECONDARY outcome
Timeframe: up to 1 hourPopulation: Participants/eyes evaluable for primary and secondary outcome measure analysis
Outcome measures
| Measure |
Conventional Microscope
n=13 Eyes
Conventional microscope used during micro-stent placement.
|
NGENUITY
n=16 Eyes
NGENUITY microscope used during micro-stent placement.
|
|---|---|---|
|
Number of Anterior Chamber Entry and Reentry Attempts During Stent Placement
|
1.14 Number of Anterior Chamber Entries
Standard Deviation 0.36
|
1.13 Number of Anterior Chamber Entries
Standard Deviation 0.35
|
SECONDARY outcome
Timeframe: up to 1 hourPopulation: Participants/eyes evaluable for primary and secondary outcome measure analysis
Outcome measures
| Measure |
Conventional Microscope
n=15 Eyes
Conventional microscope used during micro-stent placement.
|
NGENUITY
n=16 Eyes
NGENUITY microscope used during micro-stent placement.
|
|---|---|---|
|
Number of Microscope Focus or Position Readjustments Needed During Stent Placement
|
1.43 Number of Focus/Microscope adjustments
Standard Deviation 1.28
|
1.93 Number of Focus/Microscope adjustments
Standard Deviation 1.79
|
SECONDARY outcome
Timeframe: Up to 5 minutesPopulation: Participants/eyes evaluable for primary and secondary outcome measure analysis
Providers rate their comfort, visibility, image quality, focus, depth perception, staff engagement, teaching and level of confidence in using the system and system performance. Ratings are on a Likert scale of 1 to 5. Higher scores correspond to excellent ratings, higher confidence in using the system, and better system performance; for Scope Preference only, lower numbers (either group) correspond to a preference for NGenuity visualization.
Outcome measures
| Measure |
Conventional Microscope
n=13 Eyes
Conventional microscope used during micro-stent placement.
|
NGENUITY
n=16 Eyes
NGENUITY microscope used during micro-stent placement.
|
|---|---|---|
|
Change in Attending Questionnaire Score
Comfort
|
3.14 score on a scale
Standard Deviation 0.53
|
3.93 score on a scale
Standard Deviation 0.80
|
|
Change in Attending Questionnaire Score
Visibility
|
3.57 score on a scale
Standard Deviation 0.85
|
4.53 score on a scale
Standard Deviation 0.64
|
|
Change in Attending Questionnaire Score
Image Quality
|
3.14 score on a scale
Standard Deviation 0.77
|
4.6 score on a scale
Standard Deviation 0.74
|
|
Change in Attending Questionnaire Score
Focus
|
3.14 score on a scale
Standard Deviation 0.66
|
4.0 score on a scale
Standard Deviation 1.25
|
|
Change in Attending Questionnaire Score
Depth Perception
|
2.93 score on a scale
Standard Deviation 0.73
|
4.67 score on a scale
Standard Deviation 0.62
|
|
Change in Attending Questionnaire Score
Staff Engagement
|
3.36 score on a scale
Standard Deviation 0.50
|
4.27 score on a scale
Standard Deviation 0.80
|
|
Change in Attending Questionnaire Score
Teaching
|
3.29 score on a scale
Standard Deviation 0.73
|
4.67 score on a scale
Standard Deviation 0.62
|
|
Change in Attending Questionnaire Score
En Face Confidence
|
3.43 score on a scale
Standard Deviation 0.51
|
4.07 score on a scale
Standard Deviation 0.96
|
|
Change in Attending Questionnaire Score
Hydrus Placement Confidence
|
3.71 score on a scale
Standard Deviation 0.47
|
4.20 score on a scale
Standard Deviation 1.08
|
|
Change in Attending Questionnaire Score
Scope Preference (1 = 3D.)
|
2.71 score on a scale
Standard Deviation 0.61
|
1.80 score on a scale
Standard Deviation 0.86
|
SECONDARY outcome
Timeframe: Up to 5 minutesPopulation: Participants/eyes evaluable for primary and secondary outcome measure analysis
Providers rate their comfort, visibility, image quality, focus, depth perception, staff engagement, teaching and level of confidence in using the system and system performance. Ratings are on a Likert scale of 1 to 5. Higher scores correspond to excellent ratings, higher confidence in using the system, and better system performance; for Scope Preference only, lower numbers (either group) correspond to a preference for NGenuity visualization.
Outcome measures
| Measure |
Conventional Microscope
n=13 Eyes
Conventional microscope used during micro-stent placement.
|
NGENUITY
n=16 Eyes
NGENUITY microscope used during micro-stent placement.
|
|---|---|---|
|
Change in Fellow Questionnaire Score
Comfort
|
4.21 score on a scale
Standard Deviation 0.89
|
4.20 score on a scale
Standard Deviation 0.56
|
|
Change in Fellow Questionnaire Score
Image Quality
|
4.21 score on a scale
Standard Deviation 0.80
|
4.60 score on a scale
Standard Deviation 0.83
|
|
Change in Fellow Questionnaire Score
Focus
|
3.93 score on a scale
Standard Deviation 0.83
|
4.40 score on a scale
Standard Deviation 0.91
|
|
Change in Fellow Questionnaire Score
Depth Perception
|
4.29 score on a scale
Standard Deviation 0.61
|
4.73 score on a scale
Standard Deviation 0.59
|
|
Change in Fellow Questionnaire Score
Staff Engagement
|
3.57 score on a scale
Standard Deviation 0.94
|
4.73 score on a scale
Standard Deviation 0.59
|
|
Change in Fellow Questionnaire Score
Teaching
|
4.00 score on a scale
Standard Deviation 0.78
|
4.80 score on a scale
Standard Deviation 0.56
|
|
Change in Fellow Questionnaire Score
En Face Confidence
|
4.00 score on a scale
Standard Deviation 0.88
|
4.33 score on a scale
Standard Deviation 0.82
|
|
Change in Fellow Questionnaire Score
Hydrus Placement Confidence
|
4.29 score on a scale
Standard Deviation 0.61
|
4.53 score on a scale
Standard Deviation 0.83
|
|
Change in Fellow Questionnaire Score
Scope Preference (1 = 3D..)
|
3.00 score on a scale
Standard Deviation 1.11
|
1.93 score on a scale
Standard Deviation 1.10
|
|
Change in Fellow Questionnaire Score
Visibility
|
4.21 score on a scale
Standard Deviation 0.80
|
4.60 score on a scale
Standard Deviation 0.83
|
Adverse Events
NGENUITY
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Conventional Microscope (Re-randomized)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
NGENUITY (Re-randomized)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Conventional Microscope
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
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place