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Imaging

Adaptive Optics Imaging for Glaucoma

N/A

Recruiting

Led By Daniel X Hammer, Ph.D.

Research Sponsored by Food and Drug Administration (FDA)

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Have been diagnosed with POAG (cohort 2)

Are 21 years of age or older

Must not have

Have any health conditions that would contraindicate oxygen supplementation, including chronic obstructive pulmonary disease (COPD), emphysema, asthma, or any other obstructive or restrictive lung disease (oxygen challenge participants only)

Are under 21 years of age

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 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).

Awards & highlights

No Placebo-Only Group

Summary

This trial is collecting images of people's retinas in order to improve the clinical use of adaptive optics technology.

Who is the study for?

This trial is for adults over 21 with open-angle glaucoma who can follow eye exam instructions and consent to the study. It's not for those under 21, with vision correction outside +4 to -8 diopters, oxygen dependency, or certain lung diseases like COPD.

What is being tested?

The study tests adaptive optics retinal imaging technology on people with glaucoma. Participants will undergo AO imaging possibly combined with oxygen inhalation to assess enhancements in clinical use of AO tech.

What are the potential side effects?

There may be minimal side effects related to adaptive optics imaging itself; however, potential side effects from oxygen inhalation could include dry or irritated throat, nasal dryness, and minor breathing discomfort.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have been diagnosed with primary open-angle glaucoma.

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I am 21 years old or older.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I do not have lung conditions like COPD, emphysema, or asthma that would prevent me from using supplemental oxygen.

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I am younger than 21 years old.

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I am at risk for or have had acute angle closure glaucoma.

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I tested positive for COVID-19 or have light sensitivity due to it.

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I cannot have clear images taken due to a condition.

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I need oxygen support or my oxygen levels are usually below 95%.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 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).

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~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).

This trial's timeline: 3 weeks for screening, Varies for treatment, and 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). for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change in Retinal blood flow (RBF) with oxygen inhalation

Photoreceptor (PR) cell function

RGC soma diameter

+2 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

5Treatment groups

Experimental Treatment

Group I: Healthy control with stimulationExperimental Treatment1 Intervention

Healthy control subjects will undergo AO imaging at several macular locations while flashes of visible light stimulus are delivered.

Group II: Healthy control with oxygenExperimental Treatment2 Interventions

Age-matched healthy control cohort will undergo the same AO imaging procedures as glaucoma cohort. A subset of subjects will undergo the same oxygen challenge intervention as the glaucoma cohort.

Group III: Healthy controlExperimental Treatment1 Intervention

Healthy control subjects will undergo AO imaging at several macular locations without intervention

Group IV: Glaucoma with oxygenExperimental Treatment2 Interventions

Primary open angle glaucoma subjects as well as pre-perimetric glaucoma suspects will be classified by clinical exam by an experienced glaucoma specialist according to the American Academy of Ophthalmology Practice Patterns. Glaucoma subjects and suspects will undergo adaptive optics (AO) imaging of several macular locations. A subset of subjects will undergo oxygen challenge intervention, which involves breathing 100% oxygen through a mask during AO imaging at pre-determined retinal vessel locations.

Group V: GlaucomaExperimental Treatment1 Intervention

Glaucoma subjects and suspects will undergo AO imaging at several macular locations without intervention.

0 / 8Eligibility criteria met