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

Sponsored by:	Topcon Medical Systems, Inc.
Information provided by:	Topcon Medical Systems, Inc.
ClinicalTrials.gov Identifier:	NCT00792259

Purpose

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.

Condition
Retinal Disease Glaucoma

Genetics Home Reference related topics: early-onset glaucoma

MedlinePlus related topics: Glaucoma Retinal Disorders

U.S. FDA Resources

Study Type:	Observational
Study Design:	Cohort, Prospective

Further study details as provided by Topcon Medical Systems, Inc.:

Estimated Enrollment:	48
Study Start Date:	October 2008
Study Completion Date:	November 2008
Primary Completion Date:	November 2008 (Final data collection date for primary outcome measure)

Groups/Cohorts
1 Patients with Retinal Disease
2 Patients without Retinal Disease
3 Patients with Glaucoma
4 Patients without Glaucoma

Eligibility

Ages Eligible for Study:	18 Years to 80 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes
Sampling Method:	Non-Probability Sample

Study Population

ophthalmology practice

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00792259

Locations

United States, New York
Vitreous-Retina-Macula Consultants of NY
New York, New York, United States, 10022
New York Eye and Ear-Glaucoma Associates of New York
New York, New York, United States, 10003
SUNY
New York, New York, United States, 10036
Retina Consultations
Bronxville, New York, United States, 10708

Sponsors and Collaborators

Topcon Medical Systems, Inc.

More Information

Responsible Party:	Topcon Medical Systems, Inc. ( Topcon Medical Systems, Inc. )
Study ID Numbers:	Topcon 01
Study First Received:	November 14, 2008
Last Updated:	December 11, 2008
ClinicalTrials.gov Identifier:	NCT00792259
Health Authority:	United States: Institutional Review Board

Study placed in the following topic categories:

Glaucoma
Eye Diseases
Retinal Diseases
Hypertension
Ocular Hypertension

ClinicalTrials.gov processed this record on January 15, 2009