Adaptive optics imaging for Ocular Hypertension, Primary Open-angle Glaucoma (POAG)

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Food and Drug Administration, Silver Spring, MD
Ocular Hypertension, Primary Open-angle Glaucoma (POAG)+1 More
Adaptive optics imaging - Device
Eligibility
18+
All Sexes
What conditions do you have?
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Study Summary

The objective of the study is to collect and assess adaptive optics (AO) retinal images from human subjects in support of projects to demonstrate, advance, and enhance clinical use of AO technology.

Eligible Conditions

  • Ocular Hypertension, Primary Open-angle Glaucoma (POAG)

Treatment Effectiveness

Effectiveness Progress

1 of 3

Other trials for Ocular Hypertension, Primary Open-angle Glaucoma (POAG)

Study Objectives

5 Primary · 0 Secondary · Reporting Duration: RGC density will be calculated once at the AO imaging session in which RGCs are the target. For the reproducibility/longitudinal study portion, RGC density will be quantified three times over 1.5 years (visits separated by 6 months).

Week 2
Photoreceptor (PR) cell function
RBF will be measured in all subjects twice during a single AO imaging session - once before and once during pure oxygen inhalation. Subjects will be imaged only once; there is no longitudinal component to this outcome measure.
Change in Retinal blood flow (RBF) with oxygen inhalation
Year 5
Retinal ganglion cell (RGC) density
Year 5
RGC soma diameter
Week 2
Retinal pigment epithelium (RPE) cell organelle motility

Trial Safety

Safety Progress

1 of 3

Other trials for Ocular Hypertension, Primary Open-angle Glaucoma (POAG)

Trial Design

5 Treatment Groups

Glaucoma
1 of 5
Healthy control with stimulation
1 of 5
Healthy control with oxygen
1 of 5
Healthy control
1 of 5
Glaucoma with oxygen
1 of 5
Experimental Treatment

80 Total Participants · 5 Treatment Groups

Primary Treatment: Adaptive optics imaging · No Placebo Group · N/A

Glaucoma
Device
Experimental Group · 1 Intervention: Adaptive optics imaging · Intervention Types: Device
Healthy control with stimulation
Device
Experimental Group · 1 Intervention: Adaptive optics imaging · Intervention Types: Device
Healthy control with oxygenExperimental Group · 2 Interventions: Adaptive optics imaging, oxygen inhalation · Intervention Types: Device, Other
Healthy control
Device
Experimental Group · 1 Intervention: Adaptive optics imaging · Intervention Types: Device
Glaucoma with oxygenExperimental Group · 2 Interventions: Adaptive optics imaging, oxygen inhalation · Intervention Types: Device, Other

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: rgc density will be calculated once at the ao imaging session in which rgcs are the target. for the reproducibility/longitudinal study portion, rgc density will be quantified three times over 1.5 years (visits separated by 6 months).

Trial Background

Daniel Hammer, Deputy Director, Division of Biomedical Physics
Principal Investigator
Food and Drug Administration (FDA)
Closest Location: Food and Drug Administration · Silver Spring, MD
N/AFirst Recorded Clinical Trial
1 TrialsResearching Ocular Hypertension, Primary Open-angle Glaucoma (POAG)
0 CompletedClinical Trials

Eligibility Criteria

Age 18+ · All Participants · 4 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
You are eligible for this study if you are 21 years of age or older.

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.

References