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New Non-invasive Modalities for Assessing Retinal Structure and Function

R

Randy Kardon

Status

Enrolling

Conditions

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

Treatments

Device: LSFG-NAVI

Study type

Interventional

Funder types

Other

Identifiers

NCT03475173
201611825

Details and patient eligibility

About

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.

Enrollment

500 estimated patients

Sex

All

Ages

18 to 99 years old

Volunteers

Accepts Healthy Volunteers

Inclusion and exclusion 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)

Trial design

Primary purpose

Diagnostic

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

500 participants in 1 patient group

Laser Speckle Blood Flow Group
Experimental group
Treatment:
Device: LSFG-NAVI

Trial contacts and locations

1

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Central trial contact

Jan M Full, BSN; Julie K Nellis, BSN

Data sourced from clinicaltrials.gov

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