Comparing NGENUITY vs Conventional Microscope in a New Hydrus User

NCT05529966 | Completed Results FDA Device

• 1 other identifier: 66363
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Glaucoma

Outcome Measures

Primary Outcomes (1)

• Time of First Cannula in Until Satisfactory Stent Placement and Cannula Out

  up to 1 hour

Secondary Outcomes (5)

• 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

  Up to 5 minutes

• Change in Fellow Questionnaire Score

  Up to 5 minutes

Study Arms (2)

NGENUITY

EXPERIMENTAL

Research fellow participants utilize NGENUITY during micro-stent placement

Device: NGENUITY

Conventional microscope

ACTIVE COMPARATOR

Research fellow participants utilize conventional microscope during micro-stent placement

Device: Conventional microscope

Interventions

NGENUITY DEVICE

Device for 3-D viewing during placement of micro-stent placement.

NGENUITY

Conventional microscope DEVICE

Device for stereoscopic viewing during placement of micro-stent placement.

Conventional microscope

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Stanford University: lead
• Alcon Research: collaborator

Study Sites (1)

Byers Eye Institute

Palo Alto, California, 94303, United States

Location

MeSH Terms

Conditions

Glaucoma

Condition Hierarchy (Ancestors)

Ocular Hypertension; Eye Diseases

Results Point of Contact

• Title: Robert T. Chang, MD
• Organization: Stanford University

christyr@stanford.edu

650-725-5743

Study Officials

• Robert T Chang, MD

  Stanford University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Ophthalmology

Study Record Dates

• First Submitted: September 2, 2022
• First Posted: September 7, 2022
• Study Start: February 13, 2023
• Primary Completion: March 22, 2024
• Study Completion: March 22, 2024
• Last Updated: April 17, 2025
• Results First Posted: April 8, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)