Using advanced imaging to assess glaucoma

Adaptive Optics Retinal Imaging

This study is testing advanced imaging techniques to see how they can help doctors better understand and monitor glaucoma in both healthy people and those with the condition.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 150 (estimated)
• Ages: 21 Years and up
• Sex: All
• Sponsor: Food and Drug Administration (FDA) (Federal)
• Locations: 1 site (Silver Spring, Maryland)
• Trial ID: NCT05370287 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates include individuals aged 21 and older diagnosed with primary open angle glaucoma.

Not a fit: Patients with conditions that prevent adequate imaging or those with certain respiratory issues may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could improve the diagnosis and monitoring of glaucoma through enhanced imaging techniques.

How similar studies have performed: Other studies utilizing adaptive optics imaging have shown promise in enhancing the understanding and management of retinal diseases, suggesting potential success for this approach.

Eligibility criteria

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 this trial is running

Silver Spring, Maryland

• 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.

Conditions Glaucoma, Primary Open Angle