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Clinical Trial Details — Status: Withdrawn

Administrative data

NCT number NCT02432898
Other study ID # Topcon-001-2014
Secondary ID
Status Withdrawn
Phase
First received
Last updated
Start date July 2014
Est. completion date April 2015

Study information

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

Clinical Trial Summary

Evaluate the clinical information obtained from the use of the machines.


Description:

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


Recruitment information / eligibility

Status Withdrawn
Enrollment 0
Est. completion date April 2015
Est. primary completion date March 2015
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 80 Years
Eligibility 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 Design


Related Conditions & MeSH terms

  • Willing and Able Subjects for Ocular Imaging

Intervention

Device:
3D OCT-1
Spectral Domain OCT Device
3D OCT-2000
Spectral Domain OCT Device
DRI OCT-1
Swept Source OCT Device
NW-300
Fundus Camera
CT-1P
Tonometry
TRK-2P
Tonometry, Corneal Topography
SP-1P
Specular Microscopy
SL-D701
Slit Lamp Imaging
MC-4S
Visual Acuity Testing

Locations

Country Name City State
United States Topcon Medical Systems, Inc. Oakland New Jersey

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 Device Evaluation Determine Clinical Utility, Efficacy, and Safety 1 Hour