Health TrialsbyHealthPanel

Adaptive Optics Retinal Imaging

ConditionGlaucoma, Primary Open Angle
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age21+
SponsorFood and Drug Administration (FDA)

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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).

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • oxygen inhalation

    Other intervention

    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

Treatment groups

150 Participants
are divided into 5 treatment groups
Group A: Glaucoma with oxygenExperimental treatment 2 interventions
Group B: Healthy control with oxygenExperimental treatment 2 interventions
Group C: Healthy control with stimulationExperimental treatment 1 intervention
Group D: GlaucomaExperimental treatment 1 intervention
Group E: Healthy controlExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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.
2

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).
3

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).
4

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).

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Food and Drug Administration (FDA)

Lead sponsor

University of Maryland, Baltimore

Collaborator

Source ClinicalTrials.gov
Apply now