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New Non-invasive Modalities for Assessing Retinal Structure and Function

Primary Purpose

Ischemic Optic Neuropathy, Branch Retinal Artery Occlusion, Hemianopia

Status

Recruiting

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

LSFG-NAVI

About this trial

This is an interventional diagnostic trial for Ischemic Optic Neuropathy focused on measuring Optic Neuropathy, , Retinopathy

Eligibility Criteria

18 Years - 99 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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)

Sites / Locations

University of Iowa Department of OphthalmologyRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Laser Speckle Blood Flow Group

Arm Description

Outcomes

Primary Outcome Measures

Ocular Blood Flow

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

Secondary Outcome Measures

Full Information

NCT ID

NCT03475173

First Posted

March 16, 2018

Last Updated

September 14, 2023

Sponsor

Randy Kardon

1. Study Identification

Unique Protocol Identification Number

NCT03475173

Brief Title

New Non-invasive Modalities for Assessing Retinal Structure and Function

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

September 2023

Overall Recruitment Status

Recruiting

Study Start Date

May 6, 2019 (Actual)

Primary Completion Date

January 1, 2026 (Anticipated)

Study Completion Date

March 1, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor-Investigator

Name of the Sponsor

Randy Kardon

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Yes

Product Manufactured in and Exported from the U.S.

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

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

Keywords

Optic Neuropathy, , Retinopathy

7. Study Design

Primary Purpose

Diagnostic

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

500 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Laser Speckle Blood Flow Group

Arm Type

Experimental

Intervention Type

Device

Intervention Name(s)

LSFG-NAVI

Intervention Description

laser-speckle blood flow of ocular arteries and veins

Primary Outcome Measure Information:

Title

Ocular Blood Flow

Description

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

Time Frame

1 day

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

99 Years

Accepts Healthy Volunteers

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)

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Julie K Nellis, BSN

Phone

319-356-8299

julie-nellis@uiowa.edu

First Name & Middle Initial & Last Name or Official Title & Degree

Jan M Full, BSN

Phone

319-356-8299

jan-full@uiowa.edu

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Randy H Kardon, MD, PhD

Organizational Affiliation

University of Iowa Department of Ophthalmology

Official's Role

Principal Investigator

Facility Information:

Facility Name

University of Iowa Department of Ophthalmology

City

Iowa City

State/Province

Iowa

ZIP/Postal Code

52242

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Denise L Rettig, MHA. MBA

Phone

319-356-2866

Ext

5849

denise-rettig@uiowa.edu

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

New Non-invasive Modalities for Assessing Retinal Structure and Function

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