80 Participants Needed

Adaptive Optics Imaging for Glaucoma

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DX
Overseen ByDaniel X Hammer, Ph.D.
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: Food and Drug Administration (FDA)
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Approved in 3 JurisdictionsThis treatment is already approved in other countries

What You Need to Know Before You Apply

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

Is Adaptive Optics Imaging safe for humans?

Adaptive Optics Imaging is generally considered safe for humans, as it is used in retinal imaging to visualize eye structures without causing harm. However, some studies have noted that light exposure during imaging can cause changes in the retina, but these are below published safety limits.12345

How is the treatment Adaptive Optics Imaging different from other treatments for glaucoma?

Adaptive Optics Imaging is unique because it allows for high-resolution visualization of the retina, enabling direct observation of individual cells and structures like photoreceptors and nerve fibers, which can help in the early detection and understanding of glaucoma-related changes.26789

What data supports the effectiveness of the treatment Adaptive Optics Imaging for Glaucoma?

Adaptive Optics Imaging is a high-resolution technique that has been shown to provide detailed images of the retina, helping in the early diagnosis and understanding of retinal diseases like diabetic retinopathy and glaucoma. It allows for the visualization of retinal microstructures, which can be crucial for monitoring disease progression and evaluating treatment effects.27101112

Who Is on the Research Team?

DX

Daniel X Hammer, Ph.D.

Principal Investigator

Food and Drug Administration (FDA)

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

I have been diagnosed with primary open-angle glaucoma.
I can follow instructions during an eye exam.
Have the ability to understand and sign an informed consent
See 1 more

Exclusion Criteria

I do not have lung conditions like COPD, emphysema, or asthma that would prevent me from using supplemental oxygen.
I am younger than 21 years old.
Have a history of adverse reaction to mydriatic drops
See 6 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Imaging Session

Participants undergo adaptive optics (AO) retinal imaging at several macular locations using investigational multimodal AO retinal imaging systems.

1 session
1 visit (in-person)

Reproducibility Study

For reproducibility, RPE organelle motility and PR function are quantified three times over six weeks.

6 weeks
3 visits (in-person, every 2 weeks)

Longitudinal Study

RGC soma diameter and RGC density are quantified three times over 1.5 years to assess changes over time.

1.5 years
3 visits (in-person, every 6 months)

Follow-up

Participants are monitored for safety and effectiveness after imaging sessions.

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • Adaptive Optics Imaging
  • Oxygen Inhalation
Trial Overview 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.
How Is the Trial Designed?
5Treatment groups
Experimental Treatment
Group I: Healthy control with stimulationExperimental Treatment1 Intervention
Group II: Healthy control with oxygenExperimental Treatment2 Interventions
Group III: Healthy controlExperimental Treatment1 Intervention
Group IV: Glaucoma with oxygenExperimental Treatment2 Interventions
Group V: GlaucomaExperimental Treatment1 Intervention

Adaptive Optics Imaging is already approved in European Union, China, Japan for the following indications:

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Approved in European Union as Adaptive Optics Imaging for:
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Approved in China as Adaptive Optics Imaging for:
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Approved in Japan as Adaptive Optics Imaging for:

Find a Clinic Near You

Who Is Running the Clinical Trial?

Food and Drug Administration (FDA)

Lead Sponsor

Trials
184
Recruited
1,553,000+

University of Maryland, Baltimore

Collaborator

Trials
729
Recruited
540,000+

Published Research Related to This Trial

Adaptive optics (AO) technology enhances retinal imaging by correcting distortions in light waves, allowing for detailed assessment of photoreceptor cells and other retinal structures in both healthy and diseased eyes.
The transition of AO from a research tool to a diagnostic instrument is underway, with potential for improved diagnosis of retinal diseases and glaucoma, although challenges like imaging quality and cost remain.
Retinal imaging using adaptive optics technology.Kozak, I.[2021]
Adaptive optics (AO) imaging provides high-resolution details of retinal lesions in diabetic retinopathy, revealing features like hyporeflective lesions that correlate with red lesions seen in fundus photos.
The combination of AO imaging with OCT angiography allows for better differentiation of retinal conditions, such as identifying microaneurysms versus hemorrhages, which could enhance early diagnosis and understanding of diabetic retinopathy's mechanisms.
High-resolution imaging of diabetic retinopathy lesions using an adaptive optics retinal camera.Cristescu, IE., Ochinciuc, R., Balta, F., et al.[2020]
Adaptive optics significantly enhances retinal imaging by providing excellent lateral resolution, allowing for detailed visualization of photoreceptors, blood vessels, and the optic nerve head.
A comprehensive review identified 261 publications and 389 conference abstracts, highlighting the growing importance of adaptive optics in ophthalmology for studying cellular-level details in the retina.
Adaptive optics imaging of the retina.Battu, R., Dabir, S., Khanna, A., et al.[2021]

Citations

Retinal imaging using adaptive optics technology. [2021]
High-resolution imaging of diabetic retinopathy lesions using an adaptive optics retinal camera. [2020]
Adaptive optics imaging of the retina. [2021]
Adaptive optics technology for high-resolution retinal imaging. [2022]
Adaptive optics imaging of the human retina. [2023]
Rod photopigment kinetics after photodisruption of the retinal pigment epithelium. [2021]
Adaptive optics retinal imaging with automatic detection of the pupil and its boundary in real time using Shack-Hartmann images. [2018]
Light-induced retinal changes observed with high-resolution autofluorescence imaging of the retinal pigment epithelium. [2021]
Adaptive optics scanning laser ophthalmoscope-based microperimetry. [2022]
10.United Statespubmed.ncbi.nlm.nih.gov
Registration of adaptive optics corrected retinal nerve fiber layer (RNFL) images. [2022]
11.United Statespubmed.ncbi.nlm.nih.gov
Adaptive optics retinal imaging: emerging clinical applications. [2022]
12.United Statespubmed.ncbi.nlm.nih.gov
Adaptive optics imaging of healthy and abnormal regions of retinal nerve fiber bundles of patients with glaucoma. [2022]
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