Adaptive Optics Imaging for Glaucoma
What You Need to Know Before You Apply
What is the purpose of this trial?
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.
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications.
Is Adaptive Optics Imaging safe for humans?
How is the treatment Adaptive Optics Imaging different from other treatments for glaucoma?
What data supports the effectiveness of the treatment Adaptive Optics Imaging for Glaucoma?
Adaptive Optics Imaging is a high-resolution technique that has been shown to provide detailed images of the retina, helping in the early diagnosis and understanding of retinal diseases like diabetic retinopathy and glaucoma. It allows for the visualization of retinal microstructures, which can be crucial for monitoring disease progression and evaluating treatment effects.27101112
Who Is on the Research Team?
Daniel X Hammer, Ph.D.
Principal Investigator
Food and Drug Administration (FDA)
Are You a Good Fit for This Trial?
This trial is for adults over 21 with open-angle glaucoma who can follow eye exam instructions and consent to the study. It's not for those under 21, with vision correction outside +4 to -8 diopters, oxygen dependency, or certain lung diseases like COPD.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Imaging Session
Participants undergo adaptive optics (AO) retinal imaging at several macular locations using investigational multimodal AO retinal imaging systems.
Reproducibility Study
For reproducibility, RPE organelle motility and PR function are quantified three times over six weeks.
Longitudinal Study
RGC soma diameter and RGC density are quantified three times over 1.5 years to assess changes over time.
Follow-up
Participants are monitored for safety and effectiveness after imaging sessions.
What Are the Treatments Tested in This Trial?
Interventions
- Adaptive Optics Imaging
- Oxygen Inhalation
Adaptive Optics Imaging is already approved in European Union, China, Japan for the following indications:
Find a Clinic Near You
Who Is Running the Clinical Trial?
Food and Drug Administration (FDA)
Lead Sponsor
University of Maryland, Baltimore
Collaborator