NCT05529966

Comparing NGENUITY vs Conventional Microscope in a New Hydrus User

Completed NA Results posted Last updated 17 April 2025

What this trial tests

NA trial testing NGENUITY in Glaucoma in 32 participants. Completed in 22 March 2024.

Timeline

13 February 2023

Primary endpoint
22 March 2024

22 March 2024

Quick facts

Lead sponsor	Stanford University
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	other
Enrollment	32
Start date	13 February 2023
Primary completion	22 March 2024
Estimated completion	22 March 2024
Sites	1 location across United States

Drugs / interventions tested

• NGENUITY
• Conventional microscope

Conditions studied

• Glaucoma — all drugs for Glaucoma →

Sponsor

Stanford University

Who can join

18 and older, any sex, with Glaucoma. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Time of First Cannula in Until Satisfactory Stent Placement and Cannula Out Primary · up to 1 hour

Group	Value	95% CI
Conventional Microscope	2.55	± 1.36
NGENUITY	3.06	± 2.17

Number of Trabecular Meshwork Piercing Attempts Needed to Place Stent Secondary · up to 1 hour

Group	Value	95% CI
Conventional Microscope	1.50	± 0.94
NGENUITY	1.53	± 0.92

Number of Anterior Chamber Entry and Reentry Attempts During Stent Placement Secondary · up to 1 hour

Group	Value	95% CI
Conventional Microscope	1.14	± 0.36
NGENUITY	1.13	± 0.35

Number of Microscope Focus or Position Readjustments Needed During Stent Placement Secondary · up to 1 hour

Group	Value	95% CI
Conventional Microscope	1.43	± 1.28
NGENUITY	1.93	± 1.79

Change in Attending Questionnaire Score Secondary · Up to 5 minutes

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.

Comfort

Group	Value	95% CI
Conventional Microscope	3.14	± 0.53
NGENUITY	3.93	± 0.80

Visibility

Group	Value	95% CI
Conventional Microscope	3.57	± 0.85
NGENUITY	4.53	± 0.64

Image Quality

Group	Value	95% CI
Conventional Microscope	3.14	± 0.77
NGENUITY	4.6	± 0.74

Focus

Group	Value	95% CI
Conventional Microscope	3.14	± 0.66
NGENUITY	4.0	± 1.25

Depth Perception

Group	Value	95% CI
Conventional Microscope	2.93	± 0.73
NGENUITY	4.67	± 0.62

Staff Engagement

Group	Value	95% CI
Conventional Microscope	3.36	± 0.50
NGENUITY	4.27	± 0.80

Teaching

Group	Value	95% CI
Conventional Microscope	3.29	± 0.73
NGENUITY	4.67	± 0.62

En Face Confidence

Group	Value	95% CI
Conventional Microscope	3.43	± 0.51
NGENUITY	4.07	± 0.96

Change in Fellow Questionnaire Score Secondary · Up to 5 minutes

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.

Comfort

Group	Value	95% CI
Conventional Microscope	4.21	± 0.89
NGENUITY	4.20	± 0.56

Visibility

Group	Value	95% CI
Conventional Microscope	4.21	± 0.80
NGENUITY	4.60	± 0.83

Image Quality

Group	Value	95% CI
Conventional Microscope	4.21	± 0.80
NGENUITY	4.60	± 0.83

Focus

Group	Value	95% CI
Conventional Microscope	3.93	± 0.83
NGENUITY	4.40	± 0.91

Depth Perception

Group	Value	95% CI
Conventional Microscope	4.29	± 0.61
NGENUITY	4.73	± 0.59

Staff Engagement

Group	Value	95% CI
Conventional Microscope	3.57	± 0.94
NGENUITY	4.73	± 0.59

Teaching

Group	Value	95% CI
Conventional Microscope	4.00	± 0.78
NGENUITY	4.80	± 0.56

En Face Confidence

Group	Value	95% CI
Conventional Microscope	4.00	± 0.88
NGENUITY	4.33	± 0.82

Sponsor's own description

To compare the potential efficiency and educational value of using NGENUITY (3D camera system, FDA approved for this indication) vs the conventional microscope for Hydrus microstent placement by new users.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.