New Non-invasive Modalities for Assessing Retinal Structure and Function

NCT ID: NCT03475173

Last Updated: 2025-11-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

500 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-05-06

Study Completion Date

2028-03-01

Brief Summary

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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.

Detailed Description

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Conditions

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

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Laser Speckle Blood Flow Group

Group Type EXPERIMENTAL

LSFG-NAVI

Intervention Type DEVICE

laser-speckle blood flow of ocular arteries and veins

Interventions

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LSFG-NAVI

laser-speckle blood flow of ocular arteries and veins

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

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)
Minimum Eligible Age

18 Years

Maximum Eligible Age

99 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Randy Kardon

OTHER

Sponsor Role lead

Responsible Party

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Randy Kardon

Dr. Randy Kardon M.D. Ph.D Professor and Director of Neuro-ophthalmology

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Randy H Kardon, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Iowa Department of Ophthalmology

Locations

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University of Iowa Department of Ophthalmology

Iowa City, Iowa, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Julie K Nellis, BSN

Role: CONTACT

319-356-8299

Jan M Full, BSN

Role: CONTACT

319-356-8299

Facility Contacts

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Denise L Rettig, MHA. MBA

Role: primary

319-356-2866 ext. 5849

Other Identifiers

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201611825

Identifier Type: -

Identifier Source: org_study_id

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