Actively Recruiting
New Non-invasive Modalities for Assessing Retinal Structure and Function: Preliminary Investigation
Led by Randy Kardon · Updated on 2025-11-24
500
Participants Needed
1
Research Sites
8 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating a new non-invasive technology to assess the structure and function inside the eye. The study focuses on retinal imaging to detect areas of abnormal structure and function in people with inner and outer retinal defects. This technology is compared to other visual function tests to better understand eye conditions such as ischemic optic neuropathy, branch retinal artery occlusion, hemianopia, Leber hereditary optic neuropathy, and acute zonal occult outer retinopathy. The study uses a device called LSFG-NAVI, which measures laser-speckle blood flow in ocular arteries and veins. Participants include healthy controls and patients with defined inner or outer retinal defects. The imaging is non-invasive and aims to detect changes in ocular blood flow and retinal function. The study plans to enroll up to 450 participants, including 50 healthy controls and 400 patients with retinal conditions. Participants will undergo retinal imaging and ocular blood flow measurements using the LSFG-NAVI device. Assessments focus on detecting abnormalities in retinal structure and function. The primary outcome measured is ocular blood flow on the day of the imaging. Mild cataracts are allowed, but significant cataracts or other media opacities that affect retinal imaging will exclude participation. The study includes adults aged 18 to 99 years and involves monitoring and comparing retinal function with other visual tests.
CONDITIONS
Brief Title
New Non-invasive Modalities for Assessing Retinal Structure and Function
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults aged 18 to 99 years
- Controls must have had a normal eye exam within the last 2 years
- Subjects with inner retina defects including ischemic optic neuropathy, branch retinal artery occlusion, hemianopia, inherited mitochondrial optic neuropathies, or other retinopathies
- Subjects with outer retinal defects such as acute zonal occult outer retinopathy or other photoreceptor loss
You will not qualify if you...
- Cataract or media opacity that would degrade retinal imaging (mild cataracts allowed)
- Any abnormalities of the retina or optic nerve outside of normal that could affect retinal metabolism in controls
- Inability to maintain stable eye fixation during imaging
- Conditions that interfere with adequate retinal imaging quality
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 1 day
Participants undergo non-invasive laser-speckle blood flow measurements of ocular arteries and veins to assess retinal structure and function.
1 visit (in-person)
Trial Site Locations
Total: 1 location
1
University of Iowa Department of Ophthalmology
Iowa City, Iowa, United States, 52242
Actively Recruiting
Research Team
J
Julie K Nellis, BSN
J
Jan M Full, BSN
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
DIAGNOSTIC
Number of Arms
1
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