An interventional study of oxygen inhalation and Adaptive optics imaging in Glaucoma, Primary Open Angle, sponsored by Food and Drug Administration (FDA). Recruiting at 1 site in United States. Open to participants aged 21 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-05-08.
Sponsored by Food and Drug Administration (FDA) · Not applicable, Interventional, and Basic science
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.
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: One hundred (100) healthy volunteers without eye disease and fifty (50) 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.
924 studies on the registry are indexed under Glaucoma, Open-Angle; 117 are open to participants now.
This study's planned enrollment of 150 is above the median of 80 across 692 interventional studies indexed under Glaucoma, Open-Angle.
Browse Glaucoma, Open-Angle studies →Food and Drug Administration (FDA) is the lead sponsor of 25 studies on the registry; 2 are open to participants now.
Of its 15 completed or terminated interventional studies of FDA-regulated products, 13 (87%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
COPD
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Primary open angle glaucoma subjects as well as pre-perimetric glaucoma suspects will be classified by clinical exam by an experienced glaucoma specialist according to the American Academy of Ophthalmology Practice Patterns. Glaucoma subjects and suspects will undergo adaptive optics (AO) imaging of several macular locations. A subset of subjects will undergo oxygen challenge intervention, which involves breathing 100% oxygen through a mask during AO imaging at pre-determined retinal vessel locations.
Other: oxygen inhalation · Device: Adaptive optics imaging
Age-matched healthy control cohort will undergo the same AO imaging procedures as glaucoma cohort. A subset of subjects will undergo the same oxygen challenge intervention as the glaucoma cohort.
Other: oxygen inhalation · Device: Adaptive optics imaging
Healthy control subjects will undergo AO imaging at several macular locations while flashes of visible light stimulus are delivered.
Device: Adaptive optics imaging
Glaucoma subjects and suspects will undergo AO imaging at several macular locations without intervention.
Device: Adaptive optics imaging
Healthy control subjects will undergo AO imaging at several macular locations without intervention
Device: Adaptive optics imaging
Subjects will breath 100% oxygen through a mask.
Adaptive optics scanning laser ophthalmoscopy (AOSLO) and adaptive optics - optical coherence tomography (AO-OCT) retinal imaging
Change in Retinal blood flow (RBF) with oxygen inhalation
RBF \[uL/min\] will be measured from ensemble RBC velocity \[mm/s\] measurements from line-scan AOSLO videos and vessel diameter \[mm\] measurements from average AO-OCT volumes.
Time frame: 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 at specific retinal eccentricities from cells counted in average AO-OCT volumes.
Time frame: 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 soma diameter will be calculated at specific retinal eccentricities from cells segmented in average AO-OCT volumes.
Time frame: 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).
Retinal pigment epithelium (RPE) cell organelle motility
RPE cell organelle motility will be calculated from the decorrelation time constant for cells segmented from a sequence of AO-OCT volumes.
Time frame: RPE organelle motility will be calculated once at the AO imaging session in which RPE cells are the target. For the reproducibility portion of the study, RPE organelle motility will be quantified three times over six weeks (visits separated by 2 weeks).
Photoreceptor (PR) cell function
Photoreceptor cell (cone) function will be measured from phase changes between inner segment - outer segment junction and cone outer segment tip signals in a sequence of AO-OCT volumes collected during visible light stimulation.
Time frame: PR function will be calculated once at the AO imaging session in which photoreceptors are stimulated. For the reproducibility portion of the study, PR function will be quantified three times over six weeks (visits separated by 2 weeks).
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: Yes — De-identified AO images will be shared with external academic collaborators.
Time frame: For the duration of the study.
Access criteria: Available upon request.
Started Jan 2018 (actual). Primary completion is estimated for Sep 2028, 128 months after the start.
Of 100 non-industry interventional studies with no phase under Glaucoma, Open-Angle, half reached primary completion within 35 months of starting (the median), counting those still running; a quarter within 16 and three quarters within 57. This study's planned 128 months is above that.
Counting every sponsor, half of 170 studies reached it within 35 months; a quarter within 19 and three quarters within 61.
How these figures are worked out, and which studies are left out of them.
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Food and Drug Administration (FDA)