CClinicalTrials.gg
RecruitingNCT03475173Updated Sep 8, 2026

New Non-invasive Modalities for Assessing Retinal Structure and Function

An interventional study of LSFG-NAVI in Ischemic Optic Neuropathy, Branch Retinal Artery Occlusion and Hemianopia, sponsored by Randy Kardon. Recruiting at 1 site in United States. Open to participants aged 18 Years to 99 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-09-08.

Sponsored by Randy Kardon · Not applicable, Interventional, and Diagnostic

Phase
Not applicable
Study type
Interventional
Enrollment
500
Allocation
Not applicable
Ages
18 Years to 99 Years
Sex
All
01

Study 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.

02

Conditions studied

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

Keywords

  • Optic Neuropathy
  • , Retinopathy
03

Who can participate

Ages eligible
18 Years to 99 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Eligibility criteria

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)

04

Study design

Phase
Not applicable
Primary purpose
Diagnostic
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
500 participants (estimated)

Study arms

  • Experimental
    Laser Speckle Blood Flow Group

    Device: LSFG-NAVI

Interventions

  • DeviceLSFG-NAVI

    laser-speckle blood flow of ocular arteries and veins

05

What researchers measure

Primary outcomes

  1. Ocular Blood Flow

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

    Time frame: 1 day

06

Study locations

1 of 1 sites recruiting
  • University of Iowa Department of Ophthalmology
    Iowa City, Iowa 52242, United States
    Recruiting
07

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT03475173
Lead sponsor
Randy Kardon
Responsible party
Randy Kardon (Dr. Randy Kardon M.D. Ph.D Professor and Director of Neuro-ophthalmology, University of Iowa) — Sponsor-investigator
First posted
Mar 23, 2018
Start date
May 6, 2019
Primary completion
Jan 1, 2028 (estimated)
Completion
Mar 1, 2028 (estimated)
Last update
Sep 8, 2026

Study contacts

Julie K Nellis, BSN
Contact
julie-nellis@uiowa.edu
319-356-8299
Jan M Full, BSN
Contact
jan-full@uiowa.edu
319-356-8299
Randy H Kardon, MD, PhD
principal investigator · University of Iowa Department of Ophthalmology

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

Interested in this study?

Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.

Contact study team

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion