Recruiting

Adaptive Optics

Sponsor:

Food and Drug Administration (FDA)

Code:

NCT05370287

Conditions

Glaucoma, Primary Open Angle

Eligibility Criteria

Sex: All

Age: 21+

Healthy Volunteers: Accepted

Interventions

oxygen inhalation

Adaptive optics imaging

Study Details

Brief 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.

Conditions

Glaucoma, Primary Open Angle

Study ID

NCT05370287

Start date

Jan 22, 2018

Status verified date

May, 2026

Completion date

Sep 30, 2028

Anticipated

Primary completion date

Sep 30, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 21+

Healthy Volunteers: Accepted

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.

Study Design

Enrollment

150 participants

Anticipated

Allocation

Non randomized

Intervention Model

Parallel Assignment

Primary purpose

Basic Science

Interventions and Outcome Measures

Arms

experimental: Glaucoma with oxygen

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.

experimental: Healthy control with oxygen

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.

experimental: Healthy control with stimulation

Healthy control subjects will undergo AO imaging at several macular locations while flashes of visible light stimulus are delivered.

experimental: Glaucoma

Glaucoma subjects and suspects will undergo AO imaging at several macular locations without intervention.

experimental: Healthy control

Healthy control subjects will undergo AO imaging at several macular locations without intervention

Interventions

oxygen inhalation

Subjects will breath 100% oxygen through a mask.

Adaptive optics imaging

Adaptive optics scanning laser ophthalmoscopy (AOSLO) and adaptive optics - optical coherence tomography (AO-OCT) retinal imaging

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. ]
  • 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 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). ]
  • 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). ]
  • 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). ]

Central Contacts and Locations

Central contacts

Daniel X Hammer, Ph.D.

301-796-9320daniel.hammer@fda.hhs.gov

Zhuolin Liu, Ph.D.

301-796-7914zhuolin.liu@fda.hhs.gov

Locations

Food and Drug Administration

Recruiting

Silver Spring, Maryland, United States, 20993

Contacts

Daniel X Hammer, Ph.D.

301-796-9320daniel.hammer@fda.hhs.gov

Zhuolin Liu, Ph.D.

301-796-7914zhuolin.liu@fda.hhs.gov

More Information

Sponsor

Food and Drug Administration (FDA)

Last update posted

May 8, 2026

Last verified

May, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Food and Drug Administration (FDA) on 2026-05-08.