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

Study Overview
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Brief Summary
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Comparison of OCT and OCTA-based Ocular Measurements to those of Predicate

Detailed Description
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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.

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

Conditions
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Normal Eyes and Eyes With Ocular Pathologies

Intervention / Treatment
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* Device: SD-OCT


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Normal<br>no glaucoma or retinal pathology or corneal conditions | Device: SD-OCT<br>* Spectral Domain Optical Coherence Tomography for non-invasive, light-based, cross-sectional imaging of ocular structures<br>|
| Glaucoma<br>diagnosis of glaucoma | Device: SD-OCT<br>* Spectral Domain Optical Coherence Tomography for non-invasive, light-based, cross-sectional imaging of ocular structures<br>|
| Retina<br>diagnosis of AMD, DR or other retinal pathology | Device: SD-OCT<br>* Spectral Domain Optical Coherence Tomography for non-invasive, light-based, cross-sectional imaging of ocular structures<br>|
| Cornea<br>wear contact lens or prior refractive surgery or having dry eye or KCN | Device: SD-OCT<br>* Spectral Domain Optical Coherence Tomography for non-invasive, light-based, cross-sectional imaging of ocular structures<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Limits of agreement | estimation of the interval within which a proportion of the differences between measurements lie | Day 1 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Regression Analysis | statistical process for estimating the relationships among variables | Day 1 |