NCT02198560

Brief Summary

The primary objectives of the study are to assess the agreement between the two different scan mode of the RS-3000 Lite.

Trial Health

80
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at below P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

First Submitted

Initial submission to the registry

July 17, 2014

Completed
6 days until next milestone

First Posted

Study publicly available on registry

July 23, 2014

Completed
9 days until next milestone

Study Start

First participant enrolled

August 1, 2014

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2014

Completed
Last Updated

September 11, 2014

Status Verified

September 1, 2014

Enrollment Period

Same day

First QC Date

July 17, 2014

Last Update Submit

September 9, 2014

Conditions

Healthy

Keywords

Normal (Eyes without pathologies)

Outcome Measures

Primary Outcomes (1)

  • Retinal thickness and Optic Disc Analysis

    Time frame is the maximum duration of hospital stay.

    3 hours

Secondary Outcomes (1)

  • Number of participants with adverse events

    1day

Study Arms (1)

Normal (Eyes without pathology)

Device: RS-3000 Lite

Interventions

RS-3000 LiteDEVICE
Normal (Eyes without pathology)

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Normal (Eyes without pathology)

You may qualify if:

  • Subjects who do not have pathology in both eyes

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Nabeta Ganaka Iin

Okazaki, Aichi-ken, 4440226, Japan

Location

Study Design

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

Study Record Dates

First Submitted

July 17, 2014

First Posted

July 23, 2014

Study Start

August 1, 2014

Primary Completion

August 1, 2014

Last Updated

September 11, 2014

Record last verified: 2014-09

Locations

JP(1)