Topcon 3D OCT-1000 Optical Coherence Tomography System
Status
Conditions
Details and patient eligibility
About
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.
Enrollment
Sex
Ages
Volunteers
Inclusion and exclusion criteria
Retinal Disease Study
No 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
- 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 < 5.
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
- Topcon image quality factor ≥ 45 or Stratus signal strength ≥ 5.
Exclusion Criteria:
- Presence of glaucoma
- Topcon image quality factor ≤ 44 or Stratus signal strength < 5.
Trial design
48 participants in 3 patient groups
Trial contacts and locations
Loading...
Data sourced from clinicaltrials.gov
Clinical trials
Research sites
Resources
Legal