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OpenTrials
Completed

NCT Number: NCT05529966

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.

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Key information

Conditions

Glaucoma Eye Diseases Ocular Hypertension

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Byers Eye Institute

Palo Alto, California, 94303, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

NGENUITY

Device

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

Conventional microscope

Device

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

Primary outcomes

  1. Time of First Cannula in Until Satisfactory Stent Placement and Cannula Out

    Time frame: up to 1 hour

Secondary outcomes

  1. Number of Trabecular Meshwork Piercing Attempts Needed to Place Stent

    Time frame: up to 1 hour

  2. Number of Anterior Chamber Entry and Reentry Attempts During Stent Placement

    Time frame: up to 1 hour

  3. Number of Microscope Focus or Position Readjustments Needed During Stent Placement

    Time frame: up to 1 hour

  4. Change in Attending Questionnaire Score

    Time frame: 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.

  5. Change in Fellow Questionnaire Score

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Stanford University

Other

Collaborators

  • Alcon Research

Registry information

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Sep 7, 2022
Registry last updated
Apr 17, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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