New Non-invasive Modalities for Assessing Retinal Structure and Function

Last updated: May 15, 2024
Sponsor: Randy Kardon
Overall Status: Active - Recruiting

Phase

N/A

Condition

Leber's Hereditary Optic Neuropathy (Lhon)

Vision Loss

Retina

Treatment

LSFG-NAVI

Clinical Study ID

NCT03475173
201611825
  • Ages 18-99
  • All Genders
  • Accepts Healthy Volunteers

Study 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.

Eligibility Criteria

Inclusion

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)

Study Design

Total Participants: 500
Treatment Group(s): 1
Primary Treatment: LSFG-NAVI
Phase:
Study Start date:
May 06, 2019
Estimated Completion Date:
March 01, 2028

Connect with a study center

  • University of Iowa Department of Ophthalmology

    Iowa City, Iowa 52242
    United States

    Active - Recruiting

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