NCT02432898

Brief Summary

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

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Jul 2014

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2014

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

November 20, 2014

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2015

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2015

Completed
1 month until next milestone

First Posted

Study publicly available on registry

May 4, 2015

Completed
Last Updated

June 8, 2022

Status Verified

June 1, 2022

Enrollment Period

8 months

First QC Date

November 20, 2014

Last Update Submit

June 6, 2022

Conditions

Willing and Able Subjects for Ocular Imaging

Outcome Measures

Primary Outcomes (1)

  • Device Evaluation

    Determine Clinical Utility, Efficacy, and Safety

    1 Hour

Study Arms (1)

Normal Healthy Eyes

Normal healthy eyes with no known ocular diseases

Device: 3D OCT-1Device: 3D OCT-2000Device: DRI OCT-1Device: NW-300Device: CT-1PDevice: TRK-2PDevice: SP-1PDevice: SL-D701Device: MC-4S

Interventions

3D OCT-1DEVICE

Spectral Domain OCT Device

Normal Healthy Eyes
3D OCT-2000DEVICE

Spectral Domain OCT Device

Normal Healthy Eyes
DRI OCT-1DEVICE

Swept Source OCT Device

Normal Healthy Eyes
NW-300DEVICE

Fundus Camera

Normal Healthy Eyes
CT-1PDEVICE

Tonometry

Normal Healthy Eyes
TRK-2PDEVICE

Tonometry, Corneal Topography

Normal Healthy Eyes
SP-1PDEVICE

Specular Microscopy

Normal Healthy Eyes
SL-D701DEVICE

Slit Lamp Imaging

Normal Healthy Eyes
MC-4SDEVICE

Visual Acuity Testing

Normal Healthy Eyes

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Normal subjects will be recruited from Topcon Medical Systems.

You may qualify if:

  • 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.
  • Subjects who can follow the instructions by the clinical staff at the clinical site and can attend examinations on the scheduled examination date.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Topcon Medical Systems, Inc.

Oakland, New Jersey, 07436, United States

Location

Study Officials

  • Danny Leung

    Topcon Corporation

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 20, 2014

First Posted

May 4, 2015

Study Start

July 1, 2014

Primary Completion

March 1, 2015

Study Completion

April 1, 2015

Last Updated

June 8, 2022

Record last verified: 2022-06

Locations

US(1)