Non-Invasive Imaging of the Human Eye

June 6, 2022 updated by: Topcon Medical Systems, Inc.
Evaluate the clinical information obtained from the use of the machines.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Detailed Description

Evaluate the clinical information provided by these devices and determine their clinical utility and efficacy and safety.

Study Type

Observational

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New Jersey
      • Oakland, New Jersey, United States, 07436
        • Topcon Medical Systems, Inc.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Normal subjects will be recruited from Topcon Medical Systems.

Description

Inclusion Criteria:

  1. Male or female patients from 18 to 80 years old who have full legal capacity to volunteer on the date the informed consent is signed.
  2. Subjects who can follow the instructions by the clinical staff at the clinical site and can attend examinations on the scheduled examination date.

Exclusion Criteria:

  1. History of ocular pathology.
  2. History of cataract of ocular surgical procedures that render the cornea opaque or otherwise impact its ability to be imaged using the investigational device.
  3. History of systemic disease
  4. fixation problems which may prevent obtaining good quality images in the eye.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Normal Healthy Eyes
Normal healthy eyes with no known ocular diseases
Device: 3D OCT-1
Spectral Domain OCT Device
Device: 3D OCT-2000
Spectral Domain OCT Device
Device: DRI OCT-1
Swept Source OCT Device
Device: NW-300
Fundus Camera
Device: CT-1P
Tonometry
Device: TRK-2P
Tonometry, Corneal Topography
Device: SP-1P
Specular Microscopy
Device: SL-D701
Slit Lamp Imaging
Device: MC-4S
Visual Acuity Testing

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Device Evaluation
Time Frame: 1 Hour
Determine Clinical Utility, Efficacy, and Safety
1 Hour

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Topcon Medical Systems, Inc.

Investigators

  • Principal Investigator: Danny Leung, Topcon Corporation

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2014

Primary Completion (Actual)

March 1, 2015

Study Completion (Actual)

April 1, 2015

Study Registration Dates

First Submitted

November 20, 2014

First Submitted That Met QC Criteria

April 28, 2015

First Posted (Estimate)

May 4, 2015

Study Record Updates

Last Update Posted (Actual)

June 8, 2022

Last Update Submitted That Met QC Criteria

June 6, 2022

Last Verified

June 1, 2022

More Information

Terms related to this study

Other Study ID Numbers

  • Topcon-001-2014

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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