Topcon 3D OCT-1000 Optical Coherence Tomography System for Measurements of Retinal and RNFL Thicknesses: Precision and Agreement Study
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Retinal Disease
- Sponsor
- Topcon Medical Systems, Inc.
- Enrollment
- 48
- Locations
- 4
- Primary Endpoint
- Precision and Agreement Between the Topcon 3D OCT 1000 and the Identified Predicate Device
- Status
- Completed
- Last Updated
- 3 years ago
Overview
Brief Summary
The purpose of this clinical protocol is to perform a comparison of Retinal and Retinal Nerve Fiber Layer (RNFL) thickness measurements between the Topcon 3D-1000 and the identified predicate device. In addition, this protocol performs a comparison of the thickness measurement results from images collected and analyzed with the Zeiss Stratus OCT to images collected with the Zeiss Stratus OCT and imported into the Topcon 3D OCT-1000 StratusViewer for analysis.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Male or female
- •Between 18 and 80 years of age
- •Either eye, but only one eye per subject will be enrolled
- •Topcon image quality factor ≥ 45 or Stratus signal strength ≥ 5.
Exclusion Criteria
- •Any known ocular disease
- •Any systemic disease that could result in ocular manifestations such as hypertension, diabetes, heart disease, etc.
- •Topcon image quality factor ≤ 44 or Stratus signal strength \<
- •Retinal Disease
- •Inclusion Criteria:
- •Male or female
- •Between 18 and 80 years of age
- •Either eye, but only one eye per subject will be enrolled
- •Symptoms consistent with one of the following retinal diseases: diabetic macular edema, cystoid macular edema, epiretinal membrane, macular hole, wet AMD and dry AMD for which OCT imaging is warranted. At lease one (1) case each of these diseases will be included in the study
- •A range of retinal thickness will be included
Outcomes
Primary Outcomes
Precision and Agreement Between the Topcon 3D OCT 1000 and the Identified Predicate Device
Time Frame: 30 Minutes
The precision and agreement measures the thickness of RNFL and Full Retinal Thickness of the study device and is compared to the predicate device to show agreement. Keywords, ILM - Internal Limiting Membrane RPE - Retinal Pigment Epithelium RNFL - Retinal Nerve Fiber Layer