New Non-invasive Modalities for Assessing Retinal Structure and Function
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: LSFG-NAVI.
- Who it may be relevant to
- Registry conditions: Ischemic Optic Neuropathy, Branch Retinal Artery Occlusion, Hemianopia, Leber Hereditary Optic Neuropathy. Basic parameters: 18 years — 99 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
New Non-invasive Modalities for Assessing Retinal Structure and Function:Preliminary Investigation
Overview
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.
Interventions
- Device LSFG-NAVI
laser-speckle blood flow of ocular arteries and veins
Primary outcome measures
- Ocular Blood Flow [Time frame: 1 day]
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)
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Diagnostic
Study locations
United States · 1 center
- University of Iowa Department of Ophthalmology — Iowa City
Identifiers
NCT: NCT03475173 · 201611825