Glaucoma, Primary Open AngleNCT05370287
Adaptive Optics Retinal Imaging
A study testing oxygen inhalation and Adaptive optics imaging in people with Glaucoma, Primary Open Angle, run by Food and Drug Administration (FDA) at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 21 years and olderHealthy volunteers can take part
- Conditions the study is for
- Glaucoma, Primary Open Angle
- What is being tested?
- oxygen inhalation and Adaptive optics imaging
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteUnited States
- Study dates
- 22 Jan 2018to 30 Sep 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Are 21 years of age or older.
- Have the ability to cooperate with instructions during adaptive optics imaging (similar to instructions given during a clinical eye exam).
- Have the ability to understand and sign an informed consent.
- Have been diagnosed with POAG (cohort 2).
Who cannot join
- Are under 21 years of age.
- Have a condition which prevents adequate images from being obtained (e.g. unstable fixation or media opacity).
- Have visual correction outside of the range +4 diopters (D) to -8 D.
- Have a history of adverse reaction to mydriatic drops.
- Have a predisposition to (i.e., narrow iridocorneal angle) or any history of acute angle closure glaucoma (AACG).
- Do not meet the criteria for POAG as defined by the American Academy of Ophthalmology Practice Patterns (cohort 2)
Show all 10Show fewer
- 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).
- Have a dependency on oxygen support or a baseline oxygen saturation <95% (RBF experiment participants only).
- Have tested positive for COVID-19 at initial enrollment or have acute or chronic photophobia as a result of contraction.
- Are working under the direct supervision of Dr. Hammer.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Food and Drug Administration
Silver Spring, Maryland, 20993
Daniel X Hammer, Ph.D., 301-796-9320, daniel.hammer@fda.hhs.gov
Zhuolin Liu, Ph.D., 301-796-7914, zhuolin.liu@fda.hhs.gov
About this study
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.
Read the detailed description
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.
- Conditions
- Glaucoma, Primary Open Angle
- Being tested
- oxygen inhalation, Adaptive optics imaging
- Medical subject headings
- Glaucoma, Open-Angle
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
oxygen inhalationOther
Subjects will breath 100% oxygen through a mask.
Adaptive optics imagingDevice
Adaptive optics scanning laser ophthalmoscopy (AOSLO) and adaptive optics - optical coherence tomography (AO-OCT) retinal imaging
| Study group | Role | What they receive |
|---|---|---|
| Glaucoma with oxygen | Experimental | 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. Receives: Other: oxygen inhalation; Device: Adaptive optics imaging |
| Healthy control with oxygen | Experimental | 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. Receives: Other: oxygen inhalation; Device: Adaptive optics imaging |
| Healthy control with stimulation | Experimental | Healthy control subjects will undergo AO imaging at several macular locations while flashes of visible light stimulus are delivered. Receives: Device: Adaptive optics imaging |
| Glaucoma | Experimental | Glaucoma subjects and suspects will undergo AO imaging at several macular locations without intervention. Receives: Device: Adaptive optics imaging |
| Healthy control | Experimental | Healthy control subjects will undergo AO imaging at several macular locations without intervention Receives: Device: Adaptive optics imaging |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 May 2022
- Study start22 Jan 2018
- Primary completion30 Sep 2028 (estimated)
- Study completion30 Sep 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Glaucoma, Primary Open AngleStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- One cohort of subjects with clinically diagnosed glaucoma and one cohort of age-matched healthy controls with no evidence of ocular disease
- Masking
- None (open label)
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Food and Drug Administration (FDA)
- Sponsor type
- US federal agency
- Collaborators
- University of Maryland, Baltimore
- Responsible party
- Principal investigator, Daniel X. Hammer, Food and Drug Administration (FDA)
- Investigators
- Daniel X Hammer, Ph.D., Principal investigator, Food and Drug Administration (FDA)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05370287
- Sponsor's protocol ID
- 17-062R
- Status last verified
- May 2026
- First submitted
- 19 Apr 2022
- Last updated
- 8 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: De-identified AO images will be shared with external academic collaborators.
Publications
Liu Z, Tam J, Saeedi O, Hammer DX. Trans-retinal cellular imaging with multimodal adaptive optics. Biomed Opt Express. 2018 Aug 14;9(9):4246-4262. doi: 10.1364/BOE.9.004246. eCollection 2018 Sep 1.
PubMed 30615699Hammer DX, Liu Z, Cava JA, Carroll J, Saeedi O. On the axial location of Gunn's dots. Am J Ophthalmol Case Rep. 2020 Jun 1;19:100757. doi: 10.1016/j.ajoc.2020.100757. eCollection 2020 Sep.
PubMed 32551400Liu Z, Saeedi O, Zhang F, Villanueva R, Asanad S, Agrawal A, Hammer DX. Quantification of Retinal Ganglion Cell Morphology in Human Glaucomatous Eyes. Invest Ophthalmol Vis Sci. 2021 Mar 1;62(3):34. doi: 10.1167/iovs.62.3.34.
PubMed 33760041Soltanian-Zadeh S, Kurokawa K, Liu Z, Zhang F, Saeedi O, Hammer DX, Miller DT, Farsiu S. Weakly supervised individual ganglion cell segmentation from adaptive optics OCT images for glaucomatous damage assessment. Optica. 2021 May 20;8(5):642-651. doi: 10.1364/optica.418274. Epub 2021 May 4.
PubMed 35174258Villanueva R, Le C, Liu Z, Zhang F, Magder L, Hammer DX, Saeedi O. Cell - Vessel Mismatch in Glaucoma: Correlation of Ganglion Cell Layer Soma and Capillary Densities. Invest Ophthalmol Vis Sci. 2021 Oct 4;62(13):2. doi: 10.1167/iovs.62.13.2.
PubMed 34605879Hammer DX, Agrawal A, Villanueva R, Saeedi O, Liu Z. Label-free adaptive optics imaging of human retinal macrophage distribution and dynamics. Proc Natl Acad Sci U S A. 2020 Dec 1;117(48):30661-30669. doi: 10.1073/pnas.2010943117. Epub 2020 Nov 9.
PubMed 33168747Liu Z, Kurokawa K, Hammer DX, Miller DT. In vivo measurement of organelle motility in human retinal pigment epithelial cells. Biomed Opt Express. 2019 Jul 19;10(8):4142-4158. doi: 10.1364/BOE.10.004142. eCollection 2019 Aug 1.
PubMed 31453000
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Adaptive Optics Retinal Imaging
- ClinicalTrials.gov ID
- NCT05370287
- Acronym / sponsor ID
- 17-062R
- Conditions
- Glaucoma, Primary Open Angle
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Food and Drug Administration (FDA)US federal agency
- Collaborators
- University of Maryland, Baltimore
- Study start
- 22 Jan 2018 (actual)
- Primary completion
- 30 Sep 2028 (estimated)
- Study completion
- 30 Sep 2028 (estimated)
- First posted
- 11 May 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 5
- Model description
- One cohort of subjects with clinically diagnosed glaucoma and one cohort of age-matched healthy controls with no evidence of ocular disease
| Arm | Type | Receives |
|---|---|---|
| Glaucoma with oxygen | Experimental | Other: oxygen inhalation, Device: Adaptive optics imagingPrimary 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. |
| Healthy control with oxygen | Experimental | Other: oxygen inhalation, Device: Adaptive optics imagingAge-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. |
| Healthy control with stimulation | Experimental | Device: Adaptive optics imagingHealthy control subjects will undergo AO imaging at several macular locations while flashes of visible light stimulus are delivered. |
| Glaucoma | Experimental | Device: Adaptive optics imagingGlaucoma subjects and suspects will undergo AO imaging at several macular locations without intervention. |
| Healthy control | Experimental | Device: Adaptive optics imagingHealthy control subjects will undergo AO imaging at several macular locations without intervention |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Are 21 years of age or older.
- Have the ability to cooperate with instructions during adaptive optics imaging (similar to instructions given during a clinical eye exam).
- Have the ability to understand and sign an informed consent.
- Have been diagnosed with POAG (cohort 2).
Key exclusion criteria (10 listed)
- Are under 21 years of age.
- Have a condition which prevents adequate images from being obtained (e.g. unstable fixation or media opacity).
- Have visual correction outside of the range +4 diopters (D) to -8 D.
- Have a history of adverse reaction to mydriatic drops.
- Have a predisposition to (i.e., narrow iridocorneal angle) or any history of acute angle closure glaucoma (AACG).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| oxygen inhalationSubjects will breath 100% oxygen through a mask. | Other | Glaucoma with oxygen, Healthy control with oxygen |
| Adaptive optics imagingAdaptive optics scanning laser ophthalmoscopy (AOSLO) and adaptive optics - optical coherence tomography (AO-OCT) retinal imaging | Device | Glaucoma, Glaucoma with oxygen, Healthy control, Healthy control with oxygen, Healthy control with stimulation |
Primary outcome
Change in Retinal blood flow (RBF) with oxygen inhalation
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.
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.
Retinal ganglion cell (RGC) density
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 density will be calculated at specific retinal eccentricities from cells counted in average AO-OCT volumes.
RGC soma diameter
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).
RGC soma diameter will be calculated at specific retinal eccentricities from cells segmented in average AO-OCT volumes.
Retinal pigment epithelium (RPE) cell organelle motility
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).
RPE cell organelle motility will be calculated from the decorrelation time constant for cells segmented from a sequence of AO-OCT volumes.
Photoreceptor (PR) cell function
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).
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 May 2026.
- Results publication: PubMed 30615699Liu Z, Tam J, Saeedi O, Hammer DX. Trans-retinal cellular imaging with multimodal adaptive optics. Biomed Opt Express. 2018 Aug 14;9(9):4246-4262. doi: 10.1364/BOE.9.004246. eCollection 2018 Sep 1.
- Results publication: PubMed 32551400Hammer DX, Liu Z, Cava JA, Carroll J, Saeedi O. On the axial location of Gunn's dots. Am J Ophthalmol Case Rep. 2020 Jun 1;19:100757. doi: 10.1016/j.ajoc.2020.100757. eCollection 2020 Sep.
- Results publication: PubMed 33760041Liu Z, Saeedi O, Zhang F, Villanueva R, Asanad S, Agrawal A, Hammer DX. Quantification of Retinal Ganglion Cell Morphology in Human Glaucomatous Eyes. Invest Ophthalmol Vis Sci. 2021 Mar 1;62(3):34. doi: 10.1167/iovs.62.3.34.
- Results publication: PubMed 35174258Soltanian-Zadeh S, Kurokawa K, Liu Z, Zhang F, Saeedi O, Hammer DX, Miller DT, Farsiu S. Weakly supervised individual ganglion cell segmentation from adaptive optics OCT images for glaucomatous damage assessment. Optica. 2021 May 20;8(5):642-651. doi: 10.1364/optica.418274. Epub 2021 May 4.
- Results publication: PubMed 34605879Villanueva R, Le C, Liu Z, Zhang F, Magder L, Hammer DX, Saeedi O. Cell - Vessel Mismatch in Glaucoma: Correlation of Ganglion Cell Layer Soma and Capillary Densities. Invest Ophthalmol Vis Sci. 2021 Oct 4;62(13):2. doi: 10.1167/iovs.62.13.2.
- Results publication: PubMed 33168747Hammer DX, Agrawal A, Villanueva R, Saeedi O, Liu Z. Label-free adaptive optics imaging of human retinal macrophage distribution and dynamics. Proc Natl Acad Sci U S A. 2020 Dec 1;117(48):30661-30669. doi: 10.1073/pnas.2010943117. Epub 2020 Nov 9.
- Results publication: PubMed 31453000Liu Z, Kurokawa K, Hammer DX, Miller DT. In vivo measurement of organelle motility in human retinal pigment epithelial cells. Biomed Opt Express. 2019 Jul 19;10(8):4142-4158. doi: 10.1364/BOE.10.004142. eCollection 2019 Aug 1.
- Individual participant dataSharing planned: Yes. De-identified AO images will be shared with external academic collaborators.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Daniel X Hammer, Ph.D. principal investigator
Food and Drug Administration (FDA)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing oxygen inhalation and Adaptive optics imaging in people with Glaucoma, Primary Open Angle, run by Food and Drug Administration (FDA) at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 8 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Daniel X Hammer, Ph.D. (301-796-9320, daniel.hammer@fda.hhs.gov), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Retinal blood flow (RBF) with oxygen inhalation (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.). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05370287, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 May 2026.