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

Optovue199 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

199

Conditions

Normal Eyes and Eyes With Ocular Pathologies

Interventions

SD-OCTDEVICE

Spectral Domain Optical Coherence Tomography for non-invasive, light-based, cross-sectional imaging of ocular structures

Eligibility

Sex: ALLMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (2)

IOVS

Newark, New Jersey, United States

AMA

Marysville, Ohio, United States

Outcomes

Primary Outcomes

Limits of agreement

estimation of the interval within which a proportion of the differences between measurements lie

Time frame: Day 1

Secondary Outcomes

Regression Analysis

statistical process for estimating the relationships among variables

Time frame: Day 1

Data from ClinicalTrials.gov

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