New Non-invasive Modalities for Assessing Retinal Structure and Function

NCT03475173 — Not applicable, Recruiting, 500 participants, Randy Kardon

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New Non-invasive Modalities for Assessing Retinal Structure and Function:Preliminary Investigation

Registry	NCT03475173
Status	Recruiting
Phase	Not applicable
Study type	Interventional; na, single group, masking: none, diagnostic
Enrollment	500 (Estimated)
Sponsor	Randy Kardon (Other)
Conditions	Ischemic Optic Neuropathy, Branch Retinal Artery Occlusion, Hemianopia, Leber Hereditary Optic Neuropathy, Acute Zonal Occult Outer Retinopathy
Interventions	LSFG-NAVI (Device)
Dates	start 2019-05-06, primary completion 2028-01-01 (estimated), completion 2028-03-01 (estimated), first posted 2018-03-23, last updated 2026-09-08
Locations	1 site in United States

-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.

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+Arms and interventions

Arm	Type	Interventions	Description
Laser Speckle Blood Flow Group	Experimental	Device: LSFG-NAVI

LSFG-NAVI (Device): laser-speckle blood flow of ocular arteries and veins

+Outcome measures

Primary outcomes

Ocular Blood Flow [1 day]: imaging the movement of blood through blood vessels in retina and optic nerve

+Eligibility

Sex: All, ages: 18 Years to 99 Years, accepts healthy volunteers

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)

+Locations (1)

Facility	City	Country	Status
University of Iowa Department of Ophthalmology	Iowa City, Iowa	United States	Recruiting

+Investigators

Randy H Kardon, MD, PhD, Principal investigator, University of Iowa Department of Ophthalmology