N/A
Completed N=28
Comparing NGENUITY vs Conventional Microscope in a New Hydrus User
Source: ClinicalTrials.gov NCT05529966 ↗Enrolled (actual)
28
Serious AEs
0.0%
Results posted
Apr 2025
Primary outcomePrimary: Time of First Cannula in Until Satisfactory Stent Placement and Cannula Out — 2.55; 3.06 minutes — p=0.45490734
Summary
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Time of First Cannula in Until Satisfactory Stent Placement and Cannula Out |
2.55; 3.06 | 0.45490734 |
| SECONDARY Number of Trabecular Meshwork Piercing Attempts Needed to Place Stent |
1.50; 1.53 | 0.92376110 |
| SECONDARY Number of Anterior Chamber Entry and Reentry Attempts During Stent Placement |
1.14; 1.13 | 0.94342221 |
| SECONDARY Number of Microscope Focus or Position Readjustments Needed During Stent Placement |
1.43; 1.93 | 0.38902793 |
| SECONDARY Change in Attending Questionnaire Score |
3.14; 3.93; 3.57; 4.53; 3.14; 4.6 | 0.00424940 sig |
| SECONDARY Change in Fellow Questionnaire Score |
4.21; 4.20; 4.21; 4.60; 4.21; 4.60 | .959638658 |
Eligibility Criteria
Inclusion Criteria
- Patients with mild to moderate primary open angle glaucoma as defined by AGS with visually significant age-related cataract undergoing uncomplicated cataract surgery and Hydrus microstent
- Either eye or both eyes may participate
Exclusion Criteria
- Lack of patient cooperation severely affecting ability to place stent with any visualization technique
- Angle abnormalities including PAS in nasal quadrant
- Unable to properly visualize the angle due to complicated cataract surgery
Data sourced from ClinicalTrials.gov (NCT05529966). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.