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Adaptive Optics Retinal Imaging

Adaptive Optics Retinal Imaging

Recruiting
21 years and older
All
Phase N/A

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Overview

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.

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: Fifty (50) healthy volunteers without eye disease and thirty (30) 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.

Eligibility

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. 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 (oxygen challenge participants only).
  7. Have a dependency on oxygen support or a baseline oxygen saturation <95% (oxygen challenge participants only).
  8. Have tested positive for COVID-19 at initial enrollment or have acute or chronic photophobia as a result of contraction.
  9. Are working under the direct supervision of Dr. Hammer.

Study details
    Glaucoma
    Primary Open Angle

NCT05370287

Food and Drug Administration (FDA)

27 January 2024

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