Comparing NGENUITY vs Conventional Microscope in a New Hydrus User

Stanford University

Status: Completed

Conditions: Glaucoma

Treatments: Device: Conventional microscope; Device: NGENUITY

Study type: Interventional

Funder types: Other

Identifiers

NCT05529966

66363

Details and patient eligibility

About

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.

Enrollment: 32 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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32 participants in 2 patient groups

NGENUITY

Experimental group

Description:

Research fellow participants utilize NGENUITY during micro-stent placement

Treatment:

Device: NGENUITY

Conventional microscope

Active Comparator group

Description:

Research fellow participants utilize conventional microscope during micro-stent placement

Treatment:

Device: Conventional microscope