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Status:

RECRUITING

New Non-invasive Modalities for Assessing Retinal Structure and Function

Lead Sponsor:

Randy Kardon

Conditions:

Ischemic Optic Neuropathy

Branch Retinal Artery Occlusion

Eligibility:

All Genders

18-99 years

Phase:

NA

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...

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)

Exclusion

    Key Trial Info

    Start Date :

    May 6 2019

    Trial Type :

    INTERVENTIONAL

    Allocation :

    ESTIMATED

    End Date :

    March 1 2028

    Estimated Enrollment :

    500 Patients enrolled

    Trial Details

    Trial ID

    NCT03475173

    Start Date

    May 6 2019

    End Date

    March 1 2028

    Last Update

    November 24 2025

    Active Locations (1)

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    Page 1 of 1 (1 locations)

    1

    University of Iowa Department of Ophthalmology

    Iowa City, Iowa, United States, 52242