RS-3000 Lite Agreement Study

September 9, 2014 updated by: Nidek Co. LTD.
The primary objectives of the study are to assess the agreement between the two different scan mode of the RS-3000 Lite.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

30

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Japan
    • Aichi
      • Okazaki, Aichi, Japan, 4440226
        • Nabeta Ganaka Iin

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Normal (Eyes without pathology)

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Normal (Eyes without pathology)
Device: RS-3000 Lite

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Time Frame
Number of participants with adverse events
Time Frame: 1day
1day

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Nidek Co. LTD.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2014

Primary Completion (Actual)

August 1, 2014

Study Registration Dates

First Submitted

July 17, 2014

First Submitted That Met QC Criteria

July 22, 2014

First Posted (Estimate)

July 23, 2014

Study Record Updates

Last Update Posted (Estimate)

September 11, 2014

Last Update Submitted That Met QC Criteria

September 9, 2014

Last Verified

September 1, 2014

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • NRL-1

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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