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

This study has been completed.
Sponsor:
Information provided by:
Topcon Medical Systems, Inc.
ClinicalTrials.gov Identifier:
NCT00792259
First received: November 14, 2008
Last updated: June 8, 2011
Last verified: August 2010
  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

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Precision and agreement between the Topcon 3D OCT 1000 and the identified predicate device [ Time Frame: Procedure ] [ Designated as safety issue: No ]

Enrollment: 56
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
United States, New York
Retina Consultations
Bronxville, New York, United States, 10708
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
Sponsors and Collaborators
Topcon Medical Systems, Inc.
  More Information

No publications provided

Responsible Party: Topcon Medical Systems, Inc.
ClinicalTrials.gov Identifier: NCT00792259     History of Changes
Other Study ID Numbers: Topcon 01
Study First Received: November 14, 2008
Last Updated: June 8, 2011
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Glaucoma
Retinal Diseases
Ocular Hypertension
Eye Diseases

ClinicalTrials.gov processed this record on September 15, 2014