Status:
RECRUITING
Adaptive Optics Retinal Imaging
Lead Sponsor:
Food and Drug Administration (FDA)
Collaborating Sponsors:
University of Maryland, Baltimore
Conditions:
Glaucoma, Primary Open Angle
Eligibility:
All Genders
21+ years
Phase:
NA
Brief 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.
Detailed 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 te...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
January 22 2018
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 30 2026
Estimated Enrollment :
80 Patients enrolled
Trial Details
Trial ID
NCT05370287
Start Date
January 22 2018
End Date
September 30 2026
Last Update
April 3 2025
Active Locations (1)
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1
Food and Drug Administration
Silver Spring, Maryland, United States, 20993