Using advanced imaging to assess glaucoma

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study aims to collect and evaluate adaptive optics retinal images from participants to enhance the clinical application of adaptive optics technology. It involves imaging both healthy volunteers and individuals diagnosed with primary open angle glaucoma using advanced multimodal imaging systems. The study will focus on capturing high-resolution videos of retinal structures while correcting for image distortions caused by ocular aberrations. The primary outcomes will include both qualitative and quantitative assessments of the images to investigate changes related to glaucoma.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Are 21 years of age or older.
2. Have the ability to cooperate with instructions during adaptive optics imaging (similar to instructions given during a clinical eye exam).
3. Have the ability to understand and sign an informed consent.
4. Have been diagnosed with POAG (cohort 2).

Exclusion Criteria:

1. Are under 21 years of age.
2. Have a condition which prevents adequate images from being obtained (e.g. unstable fixation or media opacity).
3. Have visual correction outside of the range +4 diopters (D) to -8 D.
4. Have a history of adverse reaction to mydriatic drops.
5. Have a predisposition to (i.e., narrow iridocorneal angle) or any history of acute angle closure glaucoma (AACG).
6. Do not meet the criteria for POAG as defined by the American Academy of Ophthalmology Practice Patterns (cohort 2)
7. 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 (RBF experiment participants only).
8. Have a dependency on oxygen support or a baseline oxygen saturation \<95% (RBF experiment participants only).
9. Have tested positive for COVID-19 at initial enrollment or have acute or chronic photophobia as a result of contraction.
10. Are working under the direct supervision of Dr. Hammer.

Where it's running

• Food and Drug Administration
  Silver Spring, Maryland, United States Recruiting

Study contacts

• Principal investigator: Daniel X Hammer, Ph.D. — Food and Drug Administration (FDA)
• Study coordinator: Daniel X Hammer, Ph.D.
• Email: daniel.hammer@fda.hhs.gov
• Phone: 301-796-9320

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Imaging of outer retinal diseases using adaptive optics

  This study is trying to take detailed pictures of the retina in people with outer retinal diseases to help find better ways to diagnose and understand these conditions.

  Recruiting at 2 sites Food and Drug Administration (FDA) · Bethesda, Maryland and 1 other locations · NCT05355415

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.