New Non-invasive Modalities for Assessing Retinal Structure and Function (NCT03475173) | Clinical Trial Compass
RecruitingNot Applicable
New Non-invasive Modalities for Assessing Retinal Structure and Function
United States500 participantsStarted 2019-05-06
Plain-language 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.
Who can participate
Age range18 Years – 99 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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)