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Comparing NGENUITY vs Conventional Microscope in a New Hydrus User

Primary Purpose

Glaucoma

Status

Enrolling by invitation

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

NGENUITY

Conventional microscope

About this trial

This is an interventional other trial for Glaucoma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Byers Eye Institute

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

NGENUITY

Conventional microscope

Arm Description

Research fellow participants utilize NGENUITY during micro-stent placement

Research fellow participants utilize conventional microscope during micro-stent placement

Outcomes

Primary Outcome Measures

Time of first cannula in until satisfactory stent placement and cannula out

Secondary Outcome Measures

Number of trabecular meshwork piercing attempts needed to place stent

Number of anterior chamber entry and reentry attempts during stent placement

Number of microscope focus or position readjustments needed during stent placement

Change in attending/fellow questionnaire

Providers rate their comfort, visibility, image quality, focus, depth perception, staff engagement, teaching and level of confidence in using the system and system performance. Rating are on a scale of 1 to 5. Higher scores correspond to excellent ratings; or confidence in using the system and system performance, lower numbers correspond to a preference for NGenuity visualization.

Full Information

NCT ID

NCT05529966

First Posted

September 2, 2022

Last Updated

May 17, 2023

Sponsor

Stanford University

Collaborators

Alcon Vision

1. Study Identification

Unique Protocol Identification Number

NCT05529966

Brief Title

Comparing NGENUITY vs Conventional Microscope in a New Hydrus User

Official Title

Comparing NGENUITY vs Conventional Microscope in a New Hydrus User

Study Type

Interventional

2. Study Status

Record Verification Date

May 2023

Overall Recruitment Status

Enrolling by invitation

Study Start Date

February 13, 2023 (Actual)

Primary Completion Date

December 2023 (Anticipated)

Study Completion Date

December 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Stanford University

Collaborators

Alcon Vision

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Yes

Product Manufactured in and Exported from the U.S.

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Glaucoma

7. Study Design

Primary Purpose

Other

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Participant

Allocation

Randomized

Enrollment

16 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

NGENUITY

Arm Type

Experimental

Arm Description

Research fellow participants utilize NGENUITY during micro-stent placement

Arm Title

Conventional microscope

Arm Type

Active Comparator

Arm Description

Research fellow participants utilize conventional microscope during micro-stent placement

Intervention Type

Device

Intervention Name(s)

NGENUITY

Intervention Description

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

Intervention Type

Device

Intervention Name(s)

Conventional microscope

Intervention Description

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

Primary Outcome Measure Information:

Title

Time of first cannula in until satisfactory stent placement and cannula out

Time Frame

up to 1 hour

Secondary Outcome Measure Information:

Title

Number of trabecular meshwork piercing attempts needed to place stent

Time Frame

up to 1 hour

Title

Number of anterior chamber entry and reentry attempts during stent placement

Time Frame

up to 1 hour

Title

Number of microscope focus or position readjustments needed during stent placement

Time Frame

up to 1 hour

Title

Change in attending/fellow questionnaire

Description

Time Frame

Up to 5 minutes

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Robert T Chang, MD

Organizational Affiliation

Stanford University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Byers Eye Institute

City

Palo Alto

State/Province

California

ZIP/Postal Code

94303

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

Comparing NGENUITY vs Conventional Microscope in a New Hydrus User

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