What is this study trying to find out about primary open angle glaucoma?

This study aims to collect and analyze detailed retinal images using adaptive optics technology to better understand changes in the eyes of people with glaucoma. It involves both healthy volunteers and patients with glaucoma. The study is sponsored by the Food and Drug Administration (FDA) and helps improve imaging techniques that may support future eye care.

Who may be eligible for this primary open angle glaucoma clinical trial?

Adults aged 21 years or older who can follow instructions during eye imaging may be eligible. Participants include healthy individuals and those diagnosed with primary open angle glaucoma. People with certain lung diseases or adverse reactions to pupil-dilating drops may not qualify. Please review eligibility criteria for more details.

Is there any cost to participate in this primary open angle glaucoma clinical trial?

Study-related care, including the imaging procedures and all trial visits, is provided at no cost. However, personal travel expenses to attend study visits may vary and are not guaranteed to be covered. Participants should plan accordingly for any travel costs.

Actively Recruiting

Phase Not Applicable

Age: 21Years +

All Genders

Healthy Volunteers

ID05370287

Adaptive Optics Retinal Imaging to Study Glaucoma and Healthy Eyes Using Advanced Imaging Systems

Led by Food and Drug Administration (FDA) · Updated on 2026-05-08

150

Participants Needed

Research Sites

N/A

Total Duration

AI-Summary

What this Trial Is About

Researchers are studying the use of adaptive optics AO retinal imaging to collect and analyze detailed retinal images from both healthy individuals and those with primary open angle glaucoma POAG. The goal is to support projects that improve the clinical application of AO technology by assessing cellular changes related to glaucoma. This interventional study involves 100 healthy volunteers and 50 patients with POAG. Participants will undergo imaging using investigational AO systems that combine scanning laser ophthalmoscopy SLO and optical coherence tomography OCT to capture high-resolution videos of retinal structures. Different study groups include glaucoma patients and healthy controls, some of whom will experience an oxygen inhalation challenge or visible light stimulation during imaging. Imaging is performed at several macular locations without or with interventions depending on the group. During the study, participants will have AO imaging sessions where various retinal features such as retinal blood flow, retinal ganglion cell density and size, retinal pigment epithelium organelle movement, and photoreceptor function will be measured. Some outcomes involve repeated assessments over months to evaluate reproducibility. The study includes a single imaging visit with no long-term treatment, focusing on detailed image analysis to understand glaucoma-related changes. The total duration spans from screening through the imaging sessions and follow-up measurements as specified.

CONDITIONS

Brief Title

Adaptive Optics Retinal Imaging

Who Can Participate

Age: 21Years +

All Genders

Healthy Volunteers

Eligibility Criteria

You may qualify if you...

Are 21 years of age or older
Can cooperate with instructions during adaptive optics imaging similar to a clinical eye exam
Can understand and sign an informed consent
Have been diagnosed with primary open angle glaucoma (for glaucoma cohort)

You will not qualify if you...

Are under 21 years of age
Have conditions preventing adequate imaging such as unstable fixation or media opacity
Have visual correction outside +4 diopters to -8 diopters
Have a history of adverse reaction to mydriatic drops
Have narrow iridocorneal angle or history of acute angle closure glaucoma
Do not meet criteria for primary open angle glaucoma (for glaucoma cohort)
Have health conditions contraindicating oxygen supplementation, including COPD, emphysema, asthma, or other lung diseases (for retinal blood flow experiment)
Depend on oxygen support or have baseline oxygen saturation below 95% (for retinal blood flow experiment)
Tested positive for COVID-19 at enrollment or have acute or chronic photophobia from COVID-19
Are working under direct supervision of Dr. Hammer

Research Team

Daniel X Hammer, Ph.D.

Zhuolin Liu, Ph.D.

Not the Right Trial for You?

Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.

Already have an account? Log in here