Topcon 3D OCT-1000 Optical Coherence Tomography System

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

48 participants

Study Classification

OBSERVATIONAL

Study Start Date

2008-10-31

Study Completion Date

2008-11-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Retinal Disease Glaucoma

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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1

Patients with Retinal Disease

No interventions assigned to this group

2

Patients without Retinal Disease

No interventions assigned to this group

3

Normal Subjects

No interventions assigned to this group

Eligibility Criteria

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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.

* 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

* 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

* Presence of glaucoma
* Topcon image quality factor ≤ 44 or Stratus signal strength \< 5.

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes