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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

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

Study 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.Check my eligibility

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.See study design

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

Select...

I have been diagnosed with primary open-angle glaucoma.

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I am 21 years old or older.

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Change in Retinal blood flow (RBF) with oxygen inhalation

Photoreceptor (PR) cell function

RGC soma diameter

+2 more

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 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

University of Maryland, BaltimoreOTHER

688 Previous Clinical Trials

374,576 Total Patients Enrolled

3 Trials studying Glaucoma

250 Patients Enrolled for Glaucoma

Food and Drug Administration (FDA)Lead Sponsor

171 Previous Clinical Trials

1,331,526 Total Patients Enrolled

Daniel X Hammer, Ph.D.Principal InvestigatorFood and Drug Administration (FDA)

1 Previous Clinical Trials

100 Total Patients Enrolled

Media Library

Adaptive Optics Imaging (Imaging) Clinical Trial Eligibility Overview. Trial Name: NCT05370287 — N/A

Glaucoma Research Study Groups: Healthy control, Healthy control with stimulation, Glaucoma with oxygen, Glaucoma, Healthy control with oxygen

Glaucoma Clinical Trial 2023: Adaptive Optics Imaging Highlights & Side Effects. Trial Name: NCT05370287 — N/A

Adaptive Optics Imaging (Imaging) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05370287 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any remaining openings for individuals to participate in this clinical trial?

"As indicated by the clinicaltrials.gov records, this experiment is currently recruiting participants. The initiative was initially posted on January 22nd 2018 and last modified on May 6th 2022."

Answered by AI

To what extent is enrollment for this research endeavor being capped?

"Affirmative. Clinicaltrials.gov provides data that indicates this trial is actively recruiting members of the public, with 80 individuals needed from 1 centre. The experiment was initially posted on January 22nd 2018 and recently edited on May 6th 2022."

Answered by AI