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New Non-invasive Modalities for Assessing Retinal Structure and Function

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

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03475173
Enrollment
500
Registered
2018-03-23
Start date
2019-05-06
Completion date
2028-03-01
Last updated
2026-09-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Keywords

Optic Neuropathy, , Retinopathy

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.

Interventions

DEVICELSFG-NAVI

laser-speckle blood flow of ocular arteries and veins

Sponsors

Randy Kardon
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 99 Years
Healthy volunteers
Yes

Inclusion 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)

Design outcomes

Primary

MeasureTime frameDescription
Ocular Blood Flow1 dayimaging the movement of blood through blood vessels in retina and optic nerve

Countries

United States

Contacts

CONTACTJulie K Nellis, BSN
julie-nellis@uiowa.edu319-356-8299
CONTACTJan M Full, BSN
jan-full@uiowa.edu319-356-8299
PRINCIPAL_INVESTIGATORRandy H Kardon, MD, PhD

University of Iowa Department of Ophthalmology

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Sep 9, 2026