Topcon 3D OCT-1000 Optical Coherence Tomography System

Completed

• Conditions: Glaucoma; Retinal Disease

• Registration Number: NCT00792259
• Lead Sponsor: Topcon Medical Systems, Inc.

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-10
• Primary Completion: 2008-11
• Study Completion: 2008-11
• Study First Submitted: 2008-11-14
• Study First Submitted QC: 2008-11-14
• Study First Posted: 2008-11-17
• Results First Submitted: 2013-12-12
• Results First Submitted QC: 2015-06-15
• Results First Posted: 2015-06-17
• Status Verified: 2022-06
• Last Update Submitted: 2022-06-06
• Last Update Posted: 2022-06-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 48

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.

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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.

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Precision and Agreement Between the Topcon 3D OCT 1000 and the Identified Predicate Device	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

Trial Locations

Locations (4)

New York Eye and Ear-Glaucoma Associates of New York; 🇺🇸 New York, New York, United States

Retina Consultations; 🇺🇸 Bronxville, New York, United States

SUNY; 🇺🇸 New York, New York, United States

Vitreous-Retina-Macula Consultants of NY; 🇺🇸 New York, New York, United States