RecruitingNot ApplicableNCT05370287

Adaptive Optics Retinal Imaging


Sponsor

Food and Drug Administration (FDA)

Enrollment

80 participants

Start Date

Jan 22, 2018

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 21 Years

Inclusion Criteria4

  • 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 Criteria9

  • 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).
  • 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).
  • Have a dependency on oxygen support or a baseline oxygen saturation \<95% (oxygen challenge 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.

Interventions

OTHERoxygen inhalation

Subjects will breath 100% oxygen through a mask.

DEVICEAdaptive optics imaging

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


Locations(1)

Food and Drug Administration

Silver Spring, Maryland, United States

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NCT05370287


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