Adaptive Optics Retinal Imaging

Part of paid clinical trials in Silver Spring, Maryland.

Sponsor
Food and Drug Administration (FDA)
Study ID
NCT05370287
Status
Recruiting
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Conditions

  • Glaucoma, Primary Open Angle

Eligibility Criteria

Sex
ALL
Age
21 Years - N/A
Healthy Volunteers
Accepted

Interventions

  • oxygen inhalation — OTHER
    Subjects will breath 100% oxygen through a mask.
  • Adaptive optics imaging — DEVICE
    Adaptive optics scanning laser ophthalmoscopy (AOSLO) and adaptive optics - optical coherence tomography (AO-OCT) retinal imaging

Study Details

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.

Key Dates

Start date
Jan 22, 2018
Status verified
May 2026
Primary completion
Sep 30, 2028
Completion
Sep 30, 2028

Study Design

Enrollment
150 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE

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

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. ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Food and Drug AdministrationSilver SpringMaryland20993
Daniel X Hammer, Ph.D.
[email protected]
301-796-9320
Zhuolin Liu, Ph.D.
[email protected]
301-796-7914

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By research site
Food and Drug Administration· Silver Spring, MD

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