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NCT Number: NCT03475173

New Non-invasive Modalities for Assessing Retinal Structure and Function

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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Key information

Conditions

Ischemic Optic Neuropathy Acute Zonal Occult Outer Retinopathy Arterial Occlusive Diseases Blindness Branch Retinal Artery Occlusion Cardiovascular Diseases Congenital, Hereditary, and Neonatal Diseases and Abnormalities Cranial Nerve Diseases Eye Diseases Eye Diseases, Hereditary Genetic Diseases, Inborn Hemianopia Hemianopsia Heredodegenerative Disorders, Nervous System Leber Hereditary Optic Neuropathy Metabolic Diseases Mitochondrial Diseases Nervous System Diseases Neurodegenerative Diseases Neurologic Manifestations Nutritional and Metabolic Diseases Optic Atrophies, Hereditary Optic Atrophy Optic Atrophy, Hereditary, Leber Optic Nerve Diseases Optic Neuropathy, Ischemic Pathological Conditions, Signs and Symptoms Retinal Artery Occlusion Retinal Diseases Sensation Disorders Signs and Symptoms Vascular Diseases Vision Disorders

Age range

18 year–99 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Iowa Department of Ophthalmology

Iowa City, Iowa, 52242, United States

Location status: Recruiting

Location contact

Denise L Rettig, MHA. MBA

CONTACT

[email protected]

319-356-2866 ext. 5849

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

LSFG-NAVI

Device

laser-speckle blood flow of ocular arteries and veins

Primary outcomes

Ocular Blood Flow

Time frame: 1 day

imaging the movement of blood through blood vessels in retina and optic nerve

Study contacts

Contact information is provided by the study sponsor or research team.

Jan M Full, BSN

CONTACT

[email protected]

319-356-8299

Julie K Nellis, BSN

CONTACT

[email protected]

319-356-8299

Sponsors and collaborators

Lead sponsor

Randy Kardon

Other

Registry information

Official study title

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

Important dates

Study start: 2019
Primary completion: 2028
Study completion: 2028
First posted: Mar 23, 2018
Registry last updated: Nov 24, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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