New Non-invasive Modalities for Assessing Retinal Structure and Function
Launched by RANDY KARDON · Mar 16, 2018
Trial Information
Current as of July 12, 2025
Recruiting
Keywords
ClinConnect Summary
This clinical trial is exploring a new technology that helps doctors look at the inside of the eye to understand how well it is working. The focus is on patients who have specific eye conditions, such as Ischemic Optic Neuropathy or Leber Hereditary Optic Neuropathy, which can cause vision problems. By using advanced imaging techniques, researchers hope to find areas in the retina (the light-sensitive layer at the back of the eye) that may be damaged or not functioning properly. They are looking for a total of 450 participants, including 50 healthy individuals for comparison.
To be eligible for this study, participants with eye conditions need to have a specific type of damage to their retina, while those in the control group must have had a normal eye exam in the last two years. Everyone will need to have a clear view of their retina, meaning that any significant cataracts or other eye problems that could interfere with imaging need to be ruled out. Participants can expect to undergo non-invasive imaging tests, which means they won't require surgery or any uncomfortable procedures. The goal of this research is to improve how doctors assess and understand eye diseases, which could ultimately lead to better treatments and care for patients.
Gender
ALL
Eligibility criteria
- Controls:
- Inclusion:
- • Normal eye exam in last 2 years
- 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)
About Randy Kardon
Randy Kardon is a distinguished clinical trial sponsor known for his commitment to advancing medical research and improving patient outcomes. With a strong background in clinical medicine and a focus on innovative therapeutic solutions, he leads initiatives that explore cutting-edge treatments across various health conditions. Under his guidance, clinical trials are conducted with rigorous adherence to ethical standards and regulatory compliance, ensuring the highest quality of data collection and analysis. Randy Kardon’s dedication to collaboration and transparency fosters partnerships with academic institutions, healthcare providers, and industry stakeholders, driving forward the development of safe and effective medical interventions.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Iowa City, Iowa, United States
Patients applied
Trial Officials
Randy H Kardon, MD, PhD
Principal Investigator
University of Iowa Department of Ophthalmology
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
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