Topcon 3D OCT-1000 Optical Coherence Tomography System

Glaucoma Clinical Trial

Official title:

Topcon 3D OCT-1000 Optical Coherence Tomography System for Measurements of Retinal and RNFL Thicknesses: Precision and Agreement Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00792259
• Other study ID #: Topcon 01
• Status: Completed
• Start date: October 2008
• Est. completion date: November 2008

Study information

• Verified date: June 2022
• Source: Topcon Corporation
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 48
• Est. completion date: November 2008
• Est. primary completion date: November 2008
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Glaucoma
• Retinal Disease
• Retinal Diseases

Locations

Country	Name	City	State
United States	Retina Consultations	Bronxville	New York
United States	New York Eye and Ear-Glaucoma Associates of New York	New York	New York
United States	SUNY	New York	New York
United States	Vitreous-Retina-Macula Consultants of NY	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Topcon Medical Systems, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Precision and Agreement Between the Topcon 3D OCT 1000 and the Identified Predicate Device	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	30 Minutes