Recruiting

Observational Study

Sponsor:

Randy Kardon

Code:

NCT03475173

Conditions

Ischemic Optic Neuropathy

Branch Retinal Artery Occlusion

Hemianopia

Leber Hereditary Optic Neuropathy

Acute Zonal Occult Outer Retinopathy

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Accepted

Interventions

LSFG-NAVI

Study Details

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

Study ID

NCT03475173

Start date

May 6, 2019

Status verified date

Sep, 2026

Completion date

Mar 1, 2028

Anticipated

Primary completion date

Jan 1, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Accepted

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 Design

Enrollment

500 participants

Anticipated

Intervention Model

Single group

Primary purpose

Diagnostic

Interventions and Outcome Measures

Arms

experimental: Laser Speckle Blood Flow Group

Interventions

LSFG-NAVI

laser-speckle blood flow of ocular arteries and veins

Primary outcome measure

  • Ocular Blood Flow [ Time Frame: 1 day ]

Central Contacts and Locations

Central contacts

Locations

University of Iowa Department of Ophthalmology

Recruiting

Iowa City, Iowa, United States, 52242

Contacts

Denise L Rettig, MHA. MBA

319-356-2866denise-rettig@uiowa.edu

More Information

Sponsor

Randy Kardon

Last update posted

Sep 8, 2026

Last verified

Sep, 2026

Keywords

  • Optic Neuropathy
  • , Retinopathy

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Randy Kardon on 2026-09-08.