New Non-invasive Modalities for Assessing Retinal Structure and Function

Sponsor

Randy Kardon (Other)

Overall Status

Recruiting

CT.gov ID

NCT03475173

Collaborator

(none)

500

Enrollment

Location

Arm

57.9

Anticipated Duration (Months)

8.6

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Ischemic Optic Neuropathy Branch Retinal Artery Occlusion Hemianopia Leber Hereditary Optic Neuropathy Acute Zonal Occult Outer Retinopathy	Device: LSFG-NAVI	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

500 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Diagnostic

Official Title:

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

Actual Study Start Date :

May 6, 2019

Anticipated Primary Completion Date :

Jan 1, 2024

Anticipated Study Completion Date :

Mar 1, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Laser Speckle Blood Flow Group	Device: LSFG-NAVI laser-speckle blood flow of ocular arteries and veins

Arm

Intervention/Treatment

Experimental: Laser Speckle Blood Flow Group

Device: LSFG-NAVI

laser-speckle blood flow of ocular arteries and veins

Outcome Measures

Primary Outcome Measures

Ocular Blood Flow [1 day]
imaging the movement of blood through blood vessels in retina and optic nerve

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 99 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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)