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Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up through study completion, an average of 1 year
Awards & highlights
No Placebo-Only Group
Summary
This trial will investigate if blood flow imaging can help diagnose glaucoma. Participants will have tests to measure blood pressure, heart rate, etc & be imaged using XyCAM RI & other tools.
Who is the study for?
This trial is for adults with binocular vision who can consent, are healthy or need glaucoma assessment, or have moderate to severe glaucoma in one eye. It's not for those with significant eye issues like cataracts, past surgeries (except some), other diseases besides glaucoma, narrow angles, bad reactions to certain drugs, high refractive error (>15 diopters), or women who are pregnant/nursing.
What is being tested?
The study tests the XyCAM RI and FC devices' ability to use blood flow imaging for managing glaucoma. Participants will undergo various imaging procedures including fundus photography and ocular blood flow monitoring while breathing pure oxygen through a mask.
What are the potential side effects?
Potential side effects may include discomfort from bright lights during imaging, temporary blurred vision due to pupil dilation with tropicamide, and possible dizziness or lightheadedness when inhaling pure oxygen.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ through study completion, an average of 1 year
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~through study completion, an average of 1 year
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Blood flow velocity measure
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
3Treatment groups
Experimental Treatment
Group I: Pre-perimetric GlaucomaExperimental Treatment1 Intervention
All participants with pre-perimetric glaucoma will be first be imaged pre-intervention.
Group II: GlaucomaExperimental Treatment1 Intervention
All participants with glaucoma will be first be imaged pre-intervention.
Group III: ControlExperimental Treatment1 Intervention
All control participants will be first be imaged pre-intervention.
Find a Location
Who is running the clinical trial?
National Eye Institute (NEI)NIH
554 Previous Clinical Trials
1,407,189 Total Patients Enrolled
42 Trials studying Glaucoma
16,964 Patients Enrolled for Glaucoma
University of Maryland, BaltimoreLead Sponsor
711 Previous Clinical Trials
379,102 Total Patients Enrolled
2 Trials studying Glaucoma
100 Patients Enrolled for Glaucoma
Vasoptic Medical, IncUNKNOWN
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I have a severe vision blockage due to cataract or corneal scar.I have diabetes.I have had an eye condition other than glaucoma.I have had eye surgery, but only for cataracts, laser treatment for glaucoma, or YAG capsulotomy.I have narrow eye angles or had a bad reaction to certain eye tests.I am 18 or older and can see with both eyes.My eyesight requires a correction of more than 15 diopters.I am currently pregnant or nursing.I am either healthy, advised to get a glaucoma check, or have moderate to severe glaucoma.
Research Study Groups:
This trial has the following groups:- Group 1: Pre-perimetric Glaucoma
- Group 2: Glaucoma
- Group 3: Control
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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