Comparing NGENUITY vs Conventional Microscope in a New Hydrus User

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

32 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-02-13

Study Completion Date

2024-03-22

Brief Summary

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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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Detailed Description

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Conditions

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Glaucoma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

SINGLE

Participants

Study Groups

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NGENUITY

Research fellow participants utilize NGENUITY during micro-stent placement

Group Type EXPERIMENTAL

NGENUITY

Intervention Type DEVICE

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

Conventional microscope

Research fellow participants utilize conventional microscope during micro-stent placement

Group Type ACTIVE_COMPARATOR

Conventional microscope

Intervention Type DEVICE

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

Interventions

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NGENUITY

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

Intervention Type DEVICE

Conventional microscope

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

Intervention Type DEVICE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No