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Completed

NCT Number: NCT00792259

Topcon 3D OCT-1000 Optical Coherence Tomography System

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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Key information

Conditions

Retinal Disease Eye Diseases Glaucoma Ocular Hypertension Retinal Diseases

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Retina Consultations, Bronxville, New York, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. Precision and Agreement Between the Topcon 3D OCT 1000 and the Identified Predicate Device

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Topcon Medical Systems, Inc.

Industry

Registry information

Official study title

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

Important dates

Study start
2008
Primary completion
2008
Study completion
2008
First posted
Nov 17, 2008
Registry last updated
Jun 28, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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