Comparison of OCT and OCTA-based Ocular Measurements to Those of Predicate



Status:Enrolling by invitation
Healthy:No
Age Range:18 - Any
Updated:3/24/2019
Start Date:January 29, 2019
End Date:June 1, 2019

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Comparison of OCT and OCTA-based Ocular Measurements to those of Predicate

The purpose of this study is to compare with predicate device for the measurements of
vascular structures and anatomical structures of the posterior pole of the eye based on OCTA
and OCT scans in normal subjects, glaucoma patients, and retina patients, and to compare with
predicate device for the measurements of corneal layers based on corneal OCT scans in normal
subjects and cornea patients.

IInclusion Criteria:

- Normal - No glaucoma or treatment to lower IOP or retinal pathology for posterior
imaging; No contact lens wear, dry eye, anterior pathology or ocular surgery for
corneal imaging.

- Glaucoma - Have glaucoma and no history of other retinal pathology.

- Retina - Have retinal pathology and no history of glaucoma or treatment to lower IOP.

- Cornea - Contact lens wear or corneal condition such as dry eye, KCN, or post
refractive surgery.

Exclusion Criteria:

- Normal - Unable to complete required exams; Clinical finding of posterior pathology or
VA worse than 20/40 for posterior imaging; Clinical findings of corneal condition for
corneal imaging.

- Glaucoma - Unable to complete required exams; Clinical signs of retinal pathology.

- Retina - Unable to complete required exams.

- Cornea - Unable to complete required exams.
We found this trial at
2
sites
Newark, New Jersey 07103
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Newark, NJ
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AMA
Marysville, Ohio 43040
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Marysville, OH
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