RS-3000 Lite Agreement Study | NCT02198560

Studies
RS-3000 Lite Agreement Study

NCT02198560

Sponsor

Nidek Co. LTD.

Status

Completed

Last Update Posted

Sep 11, 2014Estimated

Enrollment

30Actual

Phase

Not provided

Conditions

Healthy

Interventions

RS-3000 Lite

Countries

Japan

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

Sep 2014

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

Aug 2014

Primary Completion Date

Aug 2014Actual

Completion Date

Not provided

First Submitted Date

Jul 17, 2014

First Submission Date that Met QC Criteria

Jul 22, 2014

First Posted Date

Jul 23, 2014Estimated

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

Sep 9, 2014

Last Update Posted Date

Sep 11, 2014Estimated

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

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

30Actual

Label	Type	Description	Intervention Names
Normal (Eyes without pathology)			Device: RS-3000 Lite

Name	Type	Description	Arm Group Labels	Other Names
RS-3000 Lite	Device		Normal (Eyes without pathology)

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Retinal thickness and Optic Disc Analysis	Time frame is the maximum duration of hospital stay.	3 hours

Secondary Outcomes

Measure	Description	Time Frame
Number of participants with adverse events		1day

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Subjects who do not have pathology in both eyes

Exclusion Criteria:

Subjects who have any of the following conditions:

Diabetes mellitus (DM) and/or diabetic retinopathy
Uncontrolled Hypertension (HT)
Cerebral infarction, cerebral hemorrhage, cranial nerve neoplasm and other central nervous system diseases affecting vision
Cardiac, hepatic, renal and hematologic diseases
A current condition requiring systemic administration of steroid
A history of, or currently receiving, anticancer therapy
Epileptic seizures which are optically induced
Dementia

Note: Additional criteria may apply

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Normal (Eyes without pathology)

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Nabeta Ganaka Iin		Okazaki	Aichi-ken	4440226	Japan