Slit Lamp and Digital Camera Attachment | NCT02444039

Studies
Slit Lamp and Digital Camera Attachment

NCT02444039

Sponsor

Topcon Medical Systems, Inc.

Status

Completed

Last Update Posted

Jun 8, 2022Actual

Enrollment

20Actual

Phase

Not provided

Conditions

Any Willing and Able Person for Ocular Imaging

Interventions

SL-D301
DC-4
SL-3G

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2022

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 2014

Primary Completion Date

Dec 2014Actual

Completion Date

Dec 2014Actual

First Submitted Date

Nov 20, 2014

First Submission Date that Met QC Criteria

May 11, 2015

First Posted Date

May 14, 2015Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 6, 2022

Last Update Posted Date

Jun 8, 2022Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The objective of the study is to compare the ease of use and performance of the SL-D301 with the DC-4 with other existing slit lamps imaging systems (SL-3G) from Topcon.

Detailed Description

The objective of the study is to compare the ease of use and performance of the SL-D301 with the DC-4 with other existing slit lamps imaging systems (SL-3G) from Topcon and ascertain that the changes and new features incorporated do not interfere with the normal use and application of the device.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

20Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Any Willing and Able Person for Ocular Imaging		Any Willing and Able Person for Ocular Imaging	Device: SL-D301 Device: DC-4 Device: SL-3G

Interventions

Name	Type	Description	Arm Group Labels	Other Names
SL-D301	Device	Slit Lamp	Any Willing and Able Person for Ocular Imaging

Measure	Description	Time Frame
Instrument and Device Evaluation		1 Hour

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Any willing subject

Exclusion Criteria:

Subjects unwilling to participate

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Any Willing and able subjects will be recruited from Topcon Medical Systems.

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Danny Leung	Topcon Corporation	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Topcon Medical Systems, Inc.		Oakland	New Jersey	07436	United States