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NCT Number: NCT05370287

Adaptive Optics Retinal Imaging

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.

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Key information

Conditions

Glaucoma, Primary Open Angle Eye Diseases Glaucoma Glaucoma, Open-Angle Ocular Hypertension

Age range

21 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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: 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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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).

Exclusion criteria

  • 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)
  • 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.

Treatment and study plan

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

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Daniel X Hammer, Ph.D.

CONTACT

[email protected]

301-796-9320

Zhuolin Liu, Ph.D.

CONTACT

[email protected]

301-796-7914

Sponsors and collaborators

Lead sponsor

Food and Drug Administration (FDA)

Fed

Collaborators

  • University of Maryland, Baltimore

Registry information

Important dates

Study start
2018
Primary completion
2028
Study completion
2028
First posted
May 11, 2022
Registry last updated
May 8, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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