New Non-invasive Modalities for Assessing Retinal Structure and Function

Hemianopia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03475173
• Other study ID #: 201611825
• Status: Recruiting
• Phase: N/A
• Start date: May 6, 2019
• Est. completion date: March 1, 2028

Study information

• Verified date: May 2024
• Source: University of Iowa
• Contact: Julie K Nellis, BSN
• Phone: 319-356-8299
• Email: julie-nellis[@]uiowa.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 500
• Est. completion date: March 1, 2028
• Est. primary completion date: January 1, 2028
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

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)

Related Conditions & MeSH terms

• Acute Zonal Occult Outer Retinopathy
• Branch Retinal Artery Occlusion
• Hemianopia
• Hemianopsia
• Ischemic Optic Neuropathy
• Leber Hereditary Optic Neuropathy
• Optic Atrophy, Hereditary, Leber
• Optic Nerve Diseases
• Optic Neuropathy, Ischemic
• Retinal Artery Occlusion
• Retinal Diseases

Intervention

Device:
• LSFG-NAVI
laser-speckle blood flow of ocular arteries and veins

Locations

Country	Name	City	State
United States	University of Iowa Department of Ophthalmology	Iowa City	Iowa

Sponsors (1)

Lead Sponsor	Collaborator
Randy Kardon

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Ocular Blood Flow	imaging the movement of blood through blood vessels in retina and optic nerve	1 day