What this study is
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.
What's being tested
- oxygen inhalation
Intervention · OTHER
Subjects will breath 100% oxygen through a mask.
- Adaptive optics imaging
Intervention · DEVICE
Adaptive optics scanning laser ophthalmoscopy (AOSLO) and adaptive optics - optical coherence tomography (AO-OCT) retinal imaging
Study details
- Sponsor
- Food and Drug Administration (FDA)
- Conditions
- Glaucoma, Primary Open Angle
- Enrolling
- 150 people
- Starts
- 2018-01-22
- Est. completion
- 2028-09-30
- Design
- Open-label, non-randomized, parallel groups
- Record
- View on ClinicalTrials.gov ↗
Who can join
Age 21 Years and overSex ALLHealthy volunteers AcceptedYou may qualify if
- 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).
You can't join if
- 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.
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
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Study locations (1)
1 openFood and Drug Administration
Silver Spring, Maryland, United States
- Daniel X Hammer, Ph.D. · Contact301-796-9320daniel.hammer@fda.hhs.gov
- Zhuolin Liu, Ph.D. · Contact301-796-7914zhuolin.liu@fda.hhs.gov
Recruiting
Study team
Sponsor
Food and Drug Administration (FDA)
Study ID 17-062R
Principal investigator
Daniel X Hammer, Ph.D.
Food and Drug Administration (FDA)
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.