New Non-invasive Modalities for Assessing Retinal Structure and Function

NCT03475173 | Recruiting FDA Device

• 1 other identifier: 201611825
• Study Type: interventional
• Target: 500
• Locations: 1 country
• Sites: 1

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.

Conditions

Ischemic Optic Neuropathy; Branch Retinal Artery Occlusion; Hemianopia; Leber Hereditary Optic Neuropathy; Acute Zonal Occult Outer Retinopathy

Keywords

Optic Neuropathy; , Retinopathy

Outcome Measures

Primary Outcomes (1)

• Ocular Blood Flow

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

  1 day

Study Arms (1)

Laser Speckle Blood Flow Group

EXPERIMENTAL

Device: LSFG-NAVI

Interventions

LSFG-NAVI DEVICE

laser-speckle blood flow of ocular arteries and veins

Laser Speckle Blood Flow Group

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Normal eye exam in last 2 years

You may not qualify if:

• 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:
• 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.
• Cataract or media opacity that would degrade the imaging of the retina. Mild cataracts are okay.
• Subjects with Outer Retinal Defect:
• AZOOR (acute zonal occult outer retinopathy) or other focal or diffuse outer photoreceptor loss of function
• Cataract or media opacity that would degrade the imaging of the retina. Mild cataracts are okay.

Sponsors & Collaborators

• Randy Kardon: lead

Study Sites (1)

University of Iowa Department of Ophthalmology

Iowa City, Iowa, 52242, United States

RECRUITING

MeSH Terms

Conditions

Optic Neuropathy, Ischemic; Retinal Artery Occlusion; Hemianopsia; Optic Atrophy, Hereditary, Leber; Acute zonal occult outer retinopathy; Optic Nerve Diseases; Retinal Diseases

Condition Hierarchy (Ancestors)

Cranial Nerve Diseases; Nervous System Diseases; Eye Diseases; Vascular Diseases; Cardiovascular Diseases; Arterial Occlusive Diseases; Vision Disorders; Sensation Disorders; Neurologic Manifestations; Blindness; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Optic Atrophies, Hereditary; Optic Atrophy; Heredodegenerative Disorders, Nervous System; Neurodegenerative Diseases; Eye Diseases, Hereditary; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Mitochondrial Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Randy H Kardon, MD, PhD

  University of Iowa Department of Ophthalmology

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Julie K Nellis, BSN

CONTACT

319-356-8299; julie-nellis@uiowa.edu

Jan M Full, BSN

CONTACT

319-356-8299; jan-full@uiowa.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Dr. Randy Kardon M.D. Ph.D Professor and Director of Neuro-ophthalmology

Study Record Dates

• First Submitted: March 16, 2018
• First Posted: March 23, 2018
• Study Start: May 6, 2019
• Primary Completion (Estimated): January 1, 2028
• Study Completion (Estimated): March 1, 2028
• Last Updated: November 24, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)