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Adaptive Optics Retinal Imaging
NCT05370287 · Food and Drug Administration (FDA)
In plain English
Click the button to translate this study into plain language — what it is, who qualifies, and what participation looks like.
About this study
Objective: 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.
Study Population: Fifty (50) healthy volunteers without eye disease and thirty (30) subjects with primary open angle glaucoma (POAG) will be enrolled.
Design: This is an interventional study protocol where participants will be imaged with investigational multimodal AO retinal imaging systems that include optical coherence tomography (OCT) and scanning laser ophthalmoscopy (SLO) channels. High resolution OCT and SLO videos will be collected while the instruments automatically detect and correct for image distortion caused by ocular aberrations. In general, videos of different retinal structures will be acquired from several retinal locations using various imaging modes.
Outcome Measures: The primary outcomes for this protocol are qualitative and quantitative assessment of the AO images and investigation of the cellular morphological and physiological changes due to glaucoma.
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. 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 (oxygen challenge participants only).
7. Have a dependency on oxygen support or a baseline oxygen saturation \<95% (oxygen challenge participants only).
8. Have tested positive for COVID-19 at initial enrollment or have acute or chronic photophobia as a result of contraction.
9. Are working under the direct supervision of Dr. Hammer.
Study design
Enrollment target: 80 participants
Allocation: non_randomized
Masking: none
Age groups: adult, older_adult
Timeline
Starts: 2018-01-22
Estimated completion: 2026-09-30
Last updated: 2025-04-03
Interventions
Other: oxygen inhalationDevice: Adaptive optics imaging
Primary outcomes
- • Change in Retinal blood flow (RBF) with oxygen inhalation (RBF will be measured in all subjects twice during a single AO imaging session - once before and once during pure oxygen inhalation. Subjects will be imaged only once; there is no longitudinal component to this outcome measure.)
- • Retinal ganglion cell (RGC) density (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).)
- • RGC soma diameter (RGC diameter will be calculated once at the AO imaging session in which RGCs are the target. For the reproducibility/longitudinal portion of the study, RGC soma diameter will be quantified three times over 1.5 years (visits separated by 6 months).)
Sponsor
Food and Drug Administration (FDA) · fed
With: University of Maryland, Baltimore
Contacts & investigators
ContactDaniel X Hammer, Ph.D. · contact · daniel.hammer@fda.hhs.gov · 301-796-9320
ContactZhuolin Liu, Ph.D. · contact · zhuolin.liu@fda.hhs.gov · 301-796-7914
InvestigatorDaniel X Hammer, Ph.D. · principal_investigator, Food and Drug Administration (FDA)
All locations (1)
Food and Drug AdministrationRecruiting
Silver Spring, Maryland, United States