Comparing NGENUITY vs Conventional Microscope in a New Hydrus User

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.

Study Overview

• Status: Completed
• Conditions: Glaucoma
• Intervention / Treatment: Device: NGENUITY; Device: Conventional microscope

• Study Type: Interventional
• Enrollment (Actual): 32
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Palo Alto, California, United States, 94303
      • Byers Eye Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: NGENUITY; Research fellow participants utilize NGENUITY during micro-stent placement	Device: NGENUITY; Device for 3-D viewing during placement of micro-stent placement.
Active Comparator: Conventional microscope; Research fellow participants utilize conventional microscope during micro-stent placement	Device: Conventional microscope; Device for stereoscopic viewing during placement of micro-stent placement.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Time of First Cannula in Until Satisfactory Stent Placement and Cannula Out	up to 1 hour

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Trabecular Meshwork Piercing Attempts Needed to Place Stent		up to 1 hour
Number of Anterior Chamber Entry and Reentry Attempts During Stent Placement		up to 1 hour
Number of Microscope Focus or Position Readjustments Needed During Stent Placement		up to 1 hour
Change in Attending Questionnaire Score	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.	Up to 5 minutes
Change in Fellow Questionnaire Score	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.	Up to 5 minutes

Collaborators and Investigators

• Sponsor: Stanford University
• Collaborators: Alcon Vision
• Investigators: Principal Investigator: Robert T Chang, MD, Stanford University

Study record dates

Study Major Dates

• Study Start (Actual): February 13, 2023
• Primary Completion (Actual): March 22, 2024
• Study Completion (Actual): March 22, 2024

Study Registration Dates

• First Submitted: September 2, 2022
• First Submitted That Met QC Criteria: September 2, 2022
• First Posted (Actual): September 7, 2022

Study Record Updates

• Last Update Posted (Actual): April 17, 2025
• Last Update Submitted That Met QC Criteria: April 10, 2025
• Last Verified: April 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Ocular Hypertension; Glaucoma
• Other Study ID Numbers: 66363

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No