NCT03475173 New Non-invasive Modalities for Assessing Retinal Structure and Function
| NCT ID | NCT03475173 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Randy Kardon |
| Condition | Ischemic Optic Neuropathy |
| Study Type | INTERVENTIONAL |
| Enrollment | 500 participants |
| Start Date | 2019-05-06 |
| Primary Completion | 2028-01-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 500 participants in total. It began in 2019-05-06 with a primary completion date of 2028-01-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
This study investigates a new technology to assess the structure and function inside the eye. Retinal imaging of subjects with inner and outer retinal defects to detect areas of abnormal structure and function compared to other visual function tests.
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)
Contact & Investigator
Randy H Kardon, MD, PhD
PRINCIPAL INVESTIGATOR
University of Iowa Department of Ophthalmology
Frequently Asked Questions
Who can join the NCT03475173 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 99 Years, studying Ischemic Optic Neuropathy. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT03475173 currently recruiting?
Yes, NCT03475173 is actively recruiting participants. Contact the research team at julie-nellis@uiowa.edu for enrollment information.
Where is the NCT03475173 trial being conducted?
This trial is being conducted at Iowa City, United States.
Who is sponsoring the NCT03475173 clinical trial?
NCT03475173 is sponsored by Randy Kardon. The principal investigator is Randy H Kardon, MD, PhD at University of Iowa Department of Ophthalmology. The trial plans to enroll 500 participants.