Ischemic Optic NeuropathyNCT03475173
New Non-invasive Modalities for Assessing Retinal Structure and Function
A study testing LSFG-NAVI in people with Ischemic Optic Neuropathy and Branch Retinal Artery Occlusion, run by Randy Kardon at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 99 yearsHealthy volunteers can take part
- Conditions the study is for
- Ischemic Optic Neuropathy, Branch Retinal Artery Occlusion, Hemianopia
- What is being tested?
- LSFG-NAVI
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 500 participants
- Where
- 1 siteUnited States
- Study dates
- 6 May 2019to 1 Mar 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Normal eye exam in last 2 years
- 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.
- AZOOR (acute zonal occult outer retinopathy) or other focal or diffuse outer photoreceptor loss of function
Who cannot join
- 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:
- Cataract or media opacity that would degrade the imaging of the retina. Mild cataracts are okay.
- Subjects with Outer Retinal Defect:
- 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)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Iowa Department of Ophthalmology
Iowa City, Iowa, 52242
Denise L Rettig, MHA. MBA, 319-356-2866 ext. 5849, denise-rettig@uiowa.edu
About this study
Official title: 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.
- Conditions
- Ischemic Optic Neuropathy, Branch Retinal Artery Occlusion, Hemianopia, Leber Hereditary Optic Neuropathy, Acute Zonal Occult Outer Retinopathy
- Being tested
- LSFG-NAVI
- Keywords
- Optic Neuropathy, , Retinopathy
- Medical subject headings
- Optic Neuropathy, Ischemic, Retinal Artery Occlusion, Hemianopsia, Optic Atrophy, Hereditary, Leber, Acute zonal occult outer retinopathy, Optic Nerve Diseases, Retinal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LSFG-NAVIDevice
laser-speckle blood flow of ocular arteries and veins
| Study group | Role | What they receive |
|---|---|---|
| Laser Speckle Blood Flow Group | Experimental | Not described Receives: Device: LSFG-NAVI |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ocular Blood Flow
imaging the movement of blood through blood vessels in retina and optic nerve
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Mar 2018
- Study start6 May 2019
- Primary completion1 Jan 2028 (estimated)
- Study completion1 Mar 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ischemic Optic NeuropathyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Randy Kardon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Randy Kardon, University of Iowa
- Investigators
- Randy H Kardon, MD, PhD, Principal investigator, University of Iowa Department of Ophthalmology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03475173
- Sponsor's protocol ID
- 201611825
- Status last verified
- Sep 2026
- First submitted
- 16 Mar 2018
- Last updated
- 8 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- New Non-invasive Modalities for Assessing Retinal Structure and Function:Preliminary Investigation
- ClinicalTrials.gov ID
- NCT03475173
- Acronym / sponsor ID
- 201611825
- Conditions
- Ischemic Optic Neuropathy, Branch Retinal Artery Occlusion, Hemianopia, Leber Hereditary Optic Neuropathy, Acute Zonal Occult Outer Retinopathy
- Keywords
- Optic Neuropathy, , Retinopathy
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Randy KardonUniversity, hospital or other
- Study start
- 6 May 2019 (actual)
- Primary completion
- 1 Jan 2028 (estimated)
- Study completion
- 1 Mar 2028 (estimated)
- First posted
- 23 Mar 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Laser Speckle Blood Flow Group | Experimental | Device: LSFG-NAVI |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Normal eye exam in last 2 years
- 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.
- AZOOR (acute zonal occult outer retinopathy) or other focal or diffuse outer photoreceptor loss of function
Key exclusion criteria (6 listed)
- 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.
- Cataract or media opacity that would degrade the imaging of the retina. Mild cataracts are okay.
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LSFG-NAVIlaser-speckle blood flow of ocular arteries and veins | Device | Laser Speckle Blood Flow Group |
Primary outcome
Ocular Blood Flow
Time frame: 1 day
imaging the movement of blood through blood vessels in retina and optic nerve
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Sep 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Randy H Kardon, MD, PhD principal investigator
University of Iowa Department of Ophthalmology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing LSFG-NAVI in people with Ischemic Optic Neuropathy and Branch Retinal Artery Occlusion, run by Randy Kardon at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 8 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Julie K Nellis, BSN (319-356-8299, julie-nellis@uiowa.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Ocular Blood Flow (time frame: 1 day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Sep 2026.