New technology for assessing eye structure and function
New Non-invasive Modalities for Assessing Retinal Structure and Function:Preliminary Investigation
This study is testing a new eye imaging technology to see if it can better understand the health of the retina in people with different eye diseases compared to regular vision tests.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 500 (estimated) |
| Ages | 18 Years to 99 Years |
| Sex | All |
| Sponsor | University of Iowa Academic / other |
| Locations | 1 site (Iowa City, Iowa) |
| Trial ID | NCT03475173 on ClinicalTrials.gov |
What this trial studies
This study investigates a novel non-invasive technology designed to evaluate the structure and function of the retina in patients with various optic neuropathies and retinopathies. By utilizing retinal imaging, the study aims to identify areas of abnormal structure and function in the retina, comparing these findings to traditional visual function tests. The intervention involves the use of LSFG-NAVI to gather detailed insights into retinal health and disease.
Who should consider this trial
Good fit: Ideal candidates include individuals with specific retinal defects such as ischemic optic neuropathy, branch retinal artery occlusion, hemianopia, and inherited mitochondrial optic neuropathies.
Not a fit: Patients with significant cataracts or media opacities that impair retinal imaging may not benefit from this study.
Why it matters
Potential benefit: If successful, this technology could lead to improved diagnostic capabilities and better management of retinal diseases.
How similar studies have performed: While this approach is innovative, similar studies have shown promise in utilizing advanced imaging techniques for retinal assessment.
Eligibility criteria
Show full inclusion / exclusion 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)
Where this trial is running
Iowa City, Iowa
- University of Iowa Department of Ophthalmology — Iowa City, Iowa, United States (Recruiting)
Study contacts
- Principal investigator: Randy H Kardon, MD, PhD — University of Iowa Department of Ophthalmology
- Study coordinator: Julie K Nellis, BSN
- Email: julie-nellis@uiowa.edu
- Phone: 319-356-8299
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.