New Non-invasive Modalities for Assessing Retinal Structure and Function
NCT ID: NCT03475173
Last Updated: 2025-11-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
500 participants
INTERVENTIONAL
2019-05-06
2028-03-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
DIAGNOSTIC
NONE
Study Groups
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Laser Speckle Blood Flow Group
LSFG-NAVI
laser-speckle blood flow of ocular arteries and veins
Interventions
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LSFG-NAVI
laser-speckle blood flow of ocular arteries and veins
Eligibility Criteria
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Inclusion Criteria
Exclusion:
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.
Subjects with Inner Retina Defect:
Inclusion:
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.
Exclusion:
Cataract or media opacity that would degrade the imaging of the retina. Mild cataracts are okay.
Subjects with Outer Retinal Defect:
Inclusion:
AZOOR (acute zonal occult outer retinopathy) or other focal or diffuse outer photoreceptor loss of function
Exclusion:
Cataract or media opacity that would degrade the imaging of the retina. Mild cataracts are okay.
The 450 total is to allow for exclusion of some subjects or in the event that the enrolled subject blinks too much or cannot fixate on a visual target adequately to maintain the same eye position during the short imaging interval. We hope to have a total of 450 (50 controls and 400 patients)
18 Years
99 Years
ALL
Yes
Sponsors
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Randy Kardon
OTHER
Responsible Party
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Randy Kardon
Dr. Randy Kardon M.D. Ph.D Professor and Director of Neuro-ophthalmology
Principal Investigators
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Randy H Kardon, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
University of Iowa Department of Ophthalmology
Locations
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University of Iowa Department of Ophthalmology
Iowa City, Iowa, United States
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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201611825
Identifier Type: -
Identifier Source: org_study_id
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