NGENUITY for Glaucoma

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Byers Eye Institute, Palo Alto, CA
Glaucoma
NGENUITY - Device
Eligibility
18+
All Sexes
What conditions do you have?
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Study 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.

Treatment Effectiveness

Study Objectives

1 Primary · 4 Secondary · Reporting Duration: Up to 5 minutes

Up to 5 minutes
Change in attending/fellow questionnaire
up to 1 hour
Number of anterior chamber entry and reentry attempts during stent placement
Number of microscope focus or position readjustments needed during stent placement
Number of trabecular meshwork piercing attempts needed to place stent
Time of first cannula in until satisfactory stent placement and cannula out

Trial Safety

Trial Design

2 Treatment Groups

Conventional microscope
1 of 2
NGENUITY
1 of 2
Active Control
Experimental Treatment

16 Total Participants · 2 Treatment Groups

Primary Treatment: NGENUITY · No Placebo Group · N/A

NGENUITY
Device
Experimental Group · 1 Intervention: NGENUITY · Intervention Types: Device
Conventional microscope
Device
ActiveComparator Group · 1 Intervention: Conventional microscope · Intervention Types: Device

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: up to 5 minutes

Trial Background

Prof. Robert T. Chang, MD
Principal Investigator
Stanford University
Closest Location: Byers Eye Institute · Palo Alto, CA
2021First Recorded Clinical Trial
1 TrialsResearching Glaucoma
1 CompletedClinical Trials

Eligibility Criteria

Age 18+ · All Participants · 2 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
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.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 9th, 2021

Last Reviewed: August 12th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.