Adaptive optics imaging for Ocular Hypertension, Primary Open-angle Glaucoma (POAG)
Phase-Based Progress Estimates
Effectiveness
Safety
Food and Drug Administration, Silver Spring, MD
Ocular Hypertension, Primary Open-angle Glaucoma (POAG)+1 More
Adaptive optics imaging - DeviceEligibility
18+
All Sexes
What conditions do you have?
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Eligibility
18+
All Sexes
What conditions do you have?
Select
Study 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.
Eligible Conditions
- Ocular Hypertension, Primary Open-angle Glaucoma (POAG)
Treatment Effectiveness
Effectiveness Progress
Other trials for Ocular Hypertension, Primary Open-angle Glaucoma (POAG)
Study Objectives
5 Primary · 0 Secondary · Reporting Duration: 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).
Week 2
Photoreceptor (PR) cell function
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.
Change in Retinal blood flow (RBF) with oxygen inhalation
Year 5
Retinal ganglion cell (RGC) density
Year 5
RGC soma diameter
Week 2
Retinal pigment epithelium (RPE) cell organelle motility
Trial Safety
Safety Progress
Other trials for Ocular Hypertension, Primary Open-angle Glaucoma (POAG)
Trial Design
5 Treatment Groups
Glaucoma
1 of 5
Healthy control with stimulation
1 of 5
Healthy control with oxygen
1 of 5
Healthy control
1 of 5
Glaucoma with oxygen
1 of 5
Experimental Treatment
80 Total Participants · 5 Treatment Groups
Primary Treatment: Adaptive optics imaging · No Placebo Group · N/A
Glaucoma
Device
Experimental Group · 1 Intervention: Adaptive optics imaging · Intervention Types: DeviceHealthy control with stimulation
Device
Experimental Group · 1 Intervention: Adaptive optics imaging · Intervention Types: DeviceHealthy control with oxygenExperimental Group · 2 Interventions: Adaptive optics imaging, oxygen inhalation · Intervention Types: Device, Other
Healthy control
Device
Experimental Group · 1 Intervention: Adaptive optics imaging · Intervention Types: DeviceGlaucoma with oxygenExperimental Group · 2 Interventions: Adaptive optics imaging, oxygen inhalation · Intervention Types: Device, Other
Trial Logistics
Trial Timeline
Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 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).
Trial Background
Daniel Hammer, Deputy Director, Division of Biomedical Physics
Principal Investigator
Food and Drug Administration (FDA)
Closest Location: Food and Drug Administration · Silver Spring, MD
N/AFirst Recorded Clinical Trial
1 TrialsResearching Ocular Hypertension, Primary Open-angle Glaucoma (POAG)
0 CompletedClinical Trials
Eligibility Criteria
Age 18+ · All Participants · 4 Total Inclusion Criteria
Mark “yes” if the following statements are true for you:You are eligible for this study if you are 21 years of age or older.
About The Reviewer
Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.
References
- Liu, Zhuolin, Osamah Saeedi, Furu Zhang, Ricardo Villanueva, Samuel Asanad, Anant Agrawal, and Daniel X. Hammer. 2021. “Quantification of Retinal Ganglion Cell Morphology in Human Glaucomatous Eyes”. Investigative Opthalmology & Visual Science. Association for Research in Vision and Ophthalmology (ARVO). doi:10.1167/iovs.62.3.34.
- Hammer, Daniel X., Anant Agrawal, Ricardo Villanueva, Osamah Saeedi, and Zhuolin Liu. 2020. “Label-free Adaptive Optics Imaging of Human Retinal Macrophage Distribution and Dynamics”. Proceedings of the National Academy of Sciences. Proceedings of the National Academy of Sciences. doi:10.1073/pnas.2010943117.
- Soltanian-Zadeh, Somayyeh, Kazuhiro Kurokawa, Zhuolin Liu, Furu Zhang, Osamah Saeedi, Daniel X. Hammer, Donald T. Miller, and Sina Farsiu. 2021. “Weakly Supervised Individual Ganglion Cell Segmentation from Adaptive Optics OCT Images for Glaucomatous Damage Assessment”. Optica. The Optical Society. doi:10.1364/optica.418274.
- Liu, Zhuolin, Johnny Tam, Osamah Saeedi, and Daniel X. Hammer. 2018. “Trans-retinal Cellular Imaging with Multimodal Adaptive Optics”. Biomedical Optics Express. The Optical Society. doi:10.1364/boe.9.004246.
- Villanueva, Ricardo, Christopher Le, Zhuolin Liu, Furu Zhang, Laurence Magder, Daniel X Hammer, and Osamah Saeedi. 2021. “Cell – Vessel Mismatch in Glaucoma: Correlation of Ganglion Cell Layer Soma and Capillary Densities”. Investigative Opthalmology & Visual Science. Association for Research in Vision and Ophthalmology (ARVO). doi:10.1167/iovs.62.13.2.
- Hammer, Daniel X., Zhuolin Liu, Jenna A. Cava, Joseph Carroll, and Osamah Saeedi. 2020. “On the Axial Location of Gunn's Dots”. American Journal of Ophthalmology Case Reports. Elsevier BV. doi:10.1016/j.ajoc.2020.100757.
- Liu, Zhuolin, Kazuhiro Kurokawa, Daniel X. Hammer, and Donald T. Miller. 2019. “In Vivo Measurement of Organelle Motility in Human Retinal Pigment Epithelial Cells”. Biomedical Optics Express. The Optical Society. doi:10.1364/boe.10.004142.
- Daniel Hammer 2018. "Adaptive Optics Retinal Imaging". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05370287.
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