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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
Study 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.Check my eligibility
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.See study design
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
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Blood flow velocity measure
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
547 Previous Clinical Trials
1,402,007 Total Patients Enrolled
41 Trials studying Glaucoma
13,251 Patients Enrolled for Glaucoma
University of Maryland, BaltimoreLead Sponsor
688 Previous Clinical Trials
374,506 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: Control
- Group 3: Glaucoma
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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is there a specific demographic eligible for this research study?
"This investigation requires glaucoma patients aged 18-88 to participate. A total of 150 participants are being sought after for enrolment."
Answered by AI
Is this research endeavor still searching for participants?
"Affirmative. Clinicaltrials.gov data shows that this medical trial, which was first posted on March 30th 2023, is actively searching for patients to enrol. About 150 participants are needed from one particular site."
Answered by AI
How many participants are enlisted in this experiment?
"Confirmed. Per the information on clinicaltrials.gov, enrollment for this trial is still open since its inception on March 30th 2023 and most recent update on May 31st 2023. The study requires 150 participants to be recruited from a single medical site."
Answered by AI
Are any minor participants being incorporated into this investigation?
"This investigation necessitates that prospective participants are between 18-88. 17 clinical trials have been established to accommodate minors, while 185 studies focus on topics involving seniors."
Answered by AI
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