OCT Agreement and Crossed Precision Study
Study Details
Study Description
Brief Summary
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.
Condition or Disease | Intervention/Treatment | Phase |
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Study Design
Arms and Interventions
Arm | Intervention/Treatment |
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Normal eyes Eyes without pathology. |
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Glaucoma Eyes with Glaucoma. |
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Retinal Eyes with Retinal Disease. |
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Corneal Eyes with corneal disease including a kerato-refractive group. |
Outcome Measures
Primary Outcome Measures
- Retinal thickness [Approximately four hours]
Time frame is the maximum duration of hospital stay
- Optic Disc Analysis [Approximately four hours]
Time frame is the maximum duration of hospital stay
- Corneal Thickness [Approximately four hours]
Time frame is the maximum duration of hospital stay
Eligibility Criteria
Criteria
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:
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Diabetic macular edema
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Dry age related macular degeneration
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Wet age related macular degeneration
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Cystoid macular edema
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Epiretinal membrane
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Macular hole
Inclusion Criteria: CORNEAL
- Subjects who has one of these diagnosis:
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Post status LASIK surgery
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Keratoconus
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Other corneal dystrophies or degenerations.
Exclusion Criteria: ALL EYES
- Subjects who have any of the following conditions
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Diabetes mellitus (DM) and/or diabetic retinopathy
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Uncontrolled Hypertension (HT)
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Cerebral infarction, cerebral hemorrhage, cranial nerve neoplasm and other central nervous system diseases affecting vision
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Cardiac, hepatic, renal and hematologic diseases
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A current condition requiring systemic administration of steroid
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A history of, or currently receiving, anticancer therapy
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Epileptic seizures which are optically induced
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Dementia
- Subjects who have other life threatening and debilitating systemic diseases
Note: Additional criteria may apply
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
---|---|---|---|---|---|
1 | WCCT Global Opthalmology Research Center | Santa Ana | California | United States | 92705 |
Sponsors and Collaborators
- Nidek Co. LTD.
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- RS-3000 series Protocol 1