OCT Agreement and Crossed Precision Study

Study Overview
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Brief Summary
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The purpose of this study is to asses the agreement of the RS-3000 Lite and RS-3000 Advance to the RS-3000, assess the crossed precision of each study device and to assess the transference of a reference database from the RS-3000 to the RS-3000 Lite and to the RS-3000 Advance.

Official Title
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Crossed Precision Design Study of the Nidek Optical Coherence Tomography RS-3000, RS-3000 Lite and RS-3000 Advance for the Measurements of Retinal and RNFL Thickness, Optic Disc Analysis, and Pachymetry

Conditions
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Glaucoma, Retinal Disease, Corneal Disease

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: NORMAL EYES Subjects who do not have pathology in both eyes Inclusion Criteria: GLAUCOMA Subjects who have a glaucoma diagnosis Inclusion Criteria: RETINAL Subjects who have a retinal diagnosis including but not limited to: Diabetic macular edema Dry age related macular degeneration Wet age related macular degeneration Cystoid macular edema Epiretinal membrane Macular hole Inclusion Criteria: CORNEAL Subjects who has one of these diagnosis: Post status LASIK surgery Keratoconus Other corneal dystrophies or degenerations. Exclusion Criteria: ALL EYES Subjects who have any of the following conditions Diabetes mellitus (DM) and/or diabetic retinopathy Uncontrolled Hypertension (HT) Cerebral infarction, cerebral hemorrhage, cranial nerve neoplasm and other central nervous system diseases affecting vision Cardiac, hepatic, renal and hematologic diseases A current condition requiring systemic administration of steroid A history of, or currently receiving, anticancer therapy Epileptic seizures which are optically induced Dementia Subjects who have other life threatening and debilitating systemic diseases Note: Additional criteria may apply

Ages Eligible for Study
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Minimum Age: 20 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 eyes<br>Eyes without pathology. | |
| Glaucoma<br>Eyes with Glaucoma. | |
| Retinal<br>Eyes with Retinal Disease. | |
| Corneal<br>Eyes with corneal disease including a kerato-refractive group. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Retinal thickness | Time frame is the maximum duration of hospital stay | Approximately four hours | 
| Optic Disc Analysis | Time frame is the maximum duration of hospital stay | Approximately four hours | 
| Corneal Thickness | Time frame is the maximum duration of hospital stay | Approximately four hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Normal Eyes, Eye; Disorder with Glaucoma, Eye; Disorder with Retinal Disease, Eye; Disorder Corneal Disease incl kerato-refractive group