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Imaging
Non-Invasive Retinal Assessment for Retinal Disease
N/A
Recruiting
Led By Randy H Kardon, MD, PhD
Research Sponsored by Randy Kardon
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Defined structural defect to include those with Ischemic optic neuropathy, branch retinal artery occlusion (BRAO), hemianopia or visual field defect that respects the vertical meridian, inherited mitochondrial optic neuropathies such as Leber's and Dominant Optic Neuropathy, other retinopathies or optic neuropathies.
Cataract or media opacity that would degrade the imaging of the retina. Mild cataracts are okay. Any abnormalities of the retina or optic nerve that could affect metabolism of the retina outside of normal.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 day
Awards & highlights
Study Summary
This trial looks at a new way to measure damage to the eye. Images of the retina are compared to other tests of visual function to see if this new method is effective.
Who is the study for?
This trial is for people with certain eye conditions like Ischemic Optic Neuropathy, Retinal Artery Occlusion, and Leber's Optic Atrophy. Participants should have had a normal eye exam in the last two years and can't have severe cataracts or other issues that would affect retinal imaging.Check my eligibility
What is being tested?
The study is testing LSFG-NAVI, a new non-invasive technology to examine the retina's structure and function. It aims to identify abnormal areas by comparing this method with other visual tests in subjects with inner or outer retinal defects.See study design
What are the potential side effects?
Since LSFG-NAVI is a diagnostic tool rather than a treatment, it typically doesn't involve side effects like medications do. However, there might be discomfort from bright lights or sitting still during the imaging process.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have a specific eye condition affecting my vision.
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I have mild cataracts or clear vision that doesn't affect detailed eye scans.
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I have been diagnosed with AZOOR or similar vision loss conditions.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 1 day
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 day
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Ocular Blood Flow
Trial Design
1Treatment groups
Experimental Treatment
Group I: Laser Speckle Blood Flow GroupExperimental Treatment1 Intervention
Find a Location
Who is running the clinical trial?
Randy KardonLead Sponsor
3 Previous Clinical Trials
621 Total Patients Enrolled
Randy H Kardon, MD, PhDPrincipal InvestigatorUniversity of Iowa Department of Ophthalmology
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- It seems like there might be some confusion or a mix-up in the provided criterion. The statement seems to be discussing the total number of subjects in a study and the reasons for exclusion. It mentions the need for 450 participants, including 50 controls and 400 patients. It also refers to a situation where a subject might blink too much or have difficulty focusing during an imaging test. If you need assistance with a different criterion or further clarification, please feel free to provide more details.I have a cataract or eye condition that does not severely affect retina imaging.My eyesight is affected by an abnormal retina or optic nerve.I have a specific eye condition affecting my vision.I have mild cataracts or clear vision that doesn't affect detailed eye scans.You had a regular eye check-up in the past 2 years and everything looked okay.I have been diagnosed with AZOOR or similar vision loss conditions.
Research Study Groups:
This trial has the following groups:- Group 1: Laser Speckle Blood Flow Group
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.
Ischemic Optic Neuropathy Patient Testimony for trial: Trial Name: NCT03475173 — N/A
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are patients being actively sought out for this experiment?
"That is accurate, the online information specifies that the study is recruiting people. The trial was established on May 6th, 2019 and the most recent update was on July 4th, 2022. The study needs 500 patients from 1 site."
Answered by AI
Are there any prerequisite health qualifications for this research?
"This trial has 500 open spots for patients that suffer from hemianopsia and are between 18 and 99 years old."
Answered by AI
Do any of the participants in this trial fall outside of the 50+ age demographic?
"Individuals that wish to partake in this clinical trial must be aged 18 to 99. Out of the 441 total trials, 41 are for patients under 18 and 272 are for patients 65 and older."
Answered by AI
Who else is applying?
What state do they live in?
Iowa
New York
How old are they?
18 - 65
What site did they apply to?
University of Iowa Department of Ophthalmology
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
How many prior treatments have patients received?
3+
Why did patients apply to this trial?
I've had medications that didn't work at all for me, I'm looking forward to new medication and to try something different.
PatientReceived no prior treatments
I am looking to better understand what happened to my bad eye and if there is a potential for this to happen in my other eye. Diagnosis improves when better information is obtained so I support any new or improved tools or procedures in this area.
PatientReceived 2+ prior treatments
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