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New Non-invasive Modalities for Assessing Retinal Structure and Function

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03475173
Recruitment Status : Recruiting
First Posted : March 23, 2018
Last Update Posted : May 9, 2019
Information provided by (Responsible Party):
Randy Kardon, University of Iowa

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.

Condition or disease Intervention/treatment Phase
Ischemic Optic Neuropathy Branch Retinal Artery Occlusion Hemianopia Leber Hereditary Optic Neuropathy Acute Zonal Occult Outer Retinopathy Device: LSFG-NAVI Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 500 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: New Non-invasive Modalities for Assessing Retinal Structure and Function:Preliminary Investigation
Actual Study Start Date : May 6, 2019
Estimated Primary Completion Date : January 1, 2020
Estimated Study Completion Date : January 1, 2020

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

Primary Outcome Measures :
  1. Ocular Blood Flow [ Time Frame: 1 day ]
    imaging the movement of blood through blood vessels in retina and optic nerve

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 99 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes



Normal eye exam in last 2 years


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.

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03475173

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Contact: Julie K Nellis, BSN 319-356-8299
Contact: Jan M Full, BSN 319-356-8299

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United States, Iowa
University of Iowa Department of Ophthalmology Recruiting
Iowa City, Iowa, United States, 52242
Contact: Denise L Rettig, MHA. MBA    319-356-2866 ext 5849   
Sponsors and Collaborators
Randy Kardon
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Principal Investigator: Randy H Kardon, MD, PhD University of Iowa Department of Ophthalmology

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Responsible Party: Randy Kardon, Dr. Randy Kardon M.D. Ph.D Professor and Director of Neuro-ophthalmology, University of Iowa Identifier: NCT03475173     History of Changes
Other Study ID Numbers: 201611825
First Posted: March 23, 2018    Key Record Dates
Last Update Posted: May 9, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: No

Keywords provided by Randy Kardon, University of Iowa:
Optic Neuropathy
, Retinopathy

Additional relevant MeSH terms:
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Peripheral Nervous System Diseases
Retinal Diseases
Optic Nerve Diseases
Optic Neuritis
Optic Neuropathy, Ischemic
Optic Atrophy, Hereditary, Leber
Retinal Artery Occlusion
Neuromuscular Diseases
Nervous System Diseases
Eye Diseases
Cranial Nerve Diseases
Vascular Diseases
Cardiovascular Diseases
Optic Atrophies, Hereditary
Optic Atrophy
Heredodegenerative Disorders, Nervous System
Neurodegenerative Diseases
Eye Diseases, Hereditary
Genetic Diseases, Inborn
Mitochondrial Diseases
Metabolic Diseases
Arterial Occlusive Diseases
Vision Disorders
Sensation Disorders
Neurologic Manifestations
Signs and Symptoms