Comparing NGENUITY vs Conventional Microscope in a New Hydrus User
Phase: NA
Conditions: Glaucoma
Sponsor: Stanford University

 
 
 
Comparing NGENUITY vs Conventional Microscope in a New 
Hydrus User 
Study Protocol 
NCT05529966 
October 4, 2022 
 
 

 
 
Comparing NGENUITY vs conventional microscope in a new Hydrus user 
Design: Prospective, masked study involving two new glaucoma Fellows learning to implant the 
Hydrus stent with supervision by single Attending.  The fellows will alternate performing the 
surgeries (N=32) utilizing NGENUITY vs Zeiss Lumera conventional microscope. 
 
Hypothesis: Hydrus cases using the NGENUITY will take less time, have fewer misdirected attempts, 
safer outcomes, and superior teaching value due to its better visualization of angle anatomy (higher 
resolution, improved depth of focus) 
 
Key Endpoints:  
Primary: Total Hydrus time (time of cannula in /out), # of attempts (piercing TM) 
  
Secondary: Other efficiency & efficacy endpoints: # of attempts entering reentering AC, 
# of times readjusting focus/microscope, rate of intraoperative adverse events, posture, 
and previously utilized Fellow and Attending questionnaire  
 
Exploratory: Safety outcomes at POD#1 and POM#1  
 
Statistical Considerations: N= 32, descriptive qualitative stats 
 
Inclusion Criteria: 
• 
Patients with mild to moderate primary open angle glaucoma as defined by AGS 
with visually significant cataract undergoing uncomplicated cataract surgery and 
Hydrus microstent 
• 
Patient is amenable to being a Fellow’s case  
• 
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