Comparing NGENUITY vs Conventional Microscope in a New Hydrus User

Glaucoma Clinical Trial

Official title:

Comparing NGENUITY vs Conventional Microscope in a New Hydrus User

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05529966
• Other study ID #: 66363
• Status: Completed
• Phase: N/A
• Start date: February 13, 2023
• Est. completion date: March 22, 2024

Study information

• Verified date: March 2024
• Source: Stanford University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 28
• Est. completion date: March 22, 2024
• Est. primary completion date: March 22, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Glaucoma

Intervention

Device:
• NGENUITY
Device for 3-D viewing during placement of micro-stent placement.
• Conventional microscope
Device for stereoscopic viewing during placement of micro-stent placement.

Locations

Country	Name	City	State
United States	Byers Eye Institute	Palo Alto	California

Sponsors (2)

Lead Sponsor	Collaborator
Stanford University	Alcon Vision

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time of first cannula in until satisfactory stent placement and cannula out		up to 1 hour
Secondary	Number of trabecular meshwork piercing attempts needed to place stent		up to 1 hour
Secondary	Number of anterior chamber entry and reentry attempts during stent placement		up to 1 hour
Secondary	Number of microscope focus or position readjustments needed during stent placement		up to 1 hour
Secondary	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.	Up to 5 minutes