New Non-invasive Modalities for Assessing Retinal Structure and Function

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

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.

Study Overview

• Status: Recruiting
• Conditions: Leber Hereditary Optic Neuropathy; Ischemic Optic Neuropathy; Hemianopia; Branch Retinal Artery Occlusion; Acute Zonal Occult Outer Retinopathy
• Intervention / Treatment: Device: LSFG-NAVI

• Study Type: Interventional
• Enrollment (Estimated): 500
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Julie K Nellis, BSN; Phone Number: 319-356-8299; Email: julie-nellis@uiowa.edu
• Study Contact Backup: Name: Jan M Full, BSN; Phone Number: 319-356-8299; Email: jan-full@uiowa.edu

Study Locations

• United States
  • Iowa
    • Iowa City, Iowa, United States, 52242
      • Recruiting
      • University of Iowa Department of Ophthalmology
      • Contact: Denise L Rettig, MHA. MBA; Phone Number: 5849 319-356-2866; Email: denise-rettig@uiowa.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 97 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Laser Speckle Blood Flow Group	Device: LSFG-NAVI; laser-speckle blood flow of ocular arteries and veins

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Ocular Blood Flow	imaging the movement of blood through blood vessels in retina and optic nerve	1 day

Collaborators and Investigators

• Sponsor: Randy Kardon
• Investigators: Principal Investigator: Randy H Kardon, MD, PhD, University of Iowa Department of Ophthalmology

Study record dates

Study Major Dates

• Study Start (Actual): May 6, 2019
• Primary Completion (Estimated): January 1, 2026
• Study Completion (Estimated): March 1, 2026

Study Registration Dates

• First Submitted: March 16, 2018
• First Submitted That Met QC Criteria: March 16, 2018
• First Posted (Actual): March 23, 2018

Study Record Updates

• Last Update Posted (Actual): September 15, 2023
• Last Update Submitted That Met QC Criteria: September 14, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Keywords: Optic Neuropathy; , Retinopathy
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Metabolic Diseases; Nervous System Diseases; Arterial Occlusive Diseases; Eye Diseases; Neurologic Manifestations; Genetic Diseases, Inborn; Neurodegenerative Diseases; Eye Diseases, Hereditary; Heredodegenerative Disorders, Nervous System; Cranial Nerve Diseases; Sensation Disorders; Optic Atrophies, Hereditary; Optic Atrophy; Mitochondrial Diseases; Vision Disorders; Blindness; Retinal Diseases; Optic Nerve Diseases; Optic Atrophy, Hereditary, Leber; Optic Neuropathy, Ischemic; Hemianopsia; Retinal Artery Occlusion
• Other Study ID Numbers: 201611825

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No