Status:
COMPLETED
Topcon 3D OCT-1000 Optical Coherence Tomography System
Lead Sponsor:
Topcon Medical Systems, Inc.
Conditions:
Retinal Disease
Glaucoma
Eligibility:
All Genders
18-80 years
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. ...
Eligibility Criteria
Inclusion
- Retinal Disease Study
- No Retinal Disease:
- 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
- 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.
Key Trial Info
Start Date :
October 1 2008
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
November 1 2008
Estimated Enrollment :
48 Patients enrolled
Trial Details
Trial ID
NCT00792259
Start Date
October 1 2008
End Date
November 1 2008
Last Update
June 28 2022
Active Locations (4)
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1
Retina Consultations
Bronxville, New York, United States, 10708
2
New York Eye and Ear-Glaucoma Associates of New York
New York, New York, United States, 10003
3
Vitreous-Retina-Macula Consultants of NY
New York, New York, United States, 10022
4
SUNY
New York, New York, United States, 10036