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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02198560
Other study ID # NRL-1
Secondary ID
Status Completed
Phase N/A
First received July 17, 2014
Last updated September 9, 2014
Start date August 2014

Study information

Verified date September 2014
Source Nidek Co. LTD.
Contact n/a
Is FDA regulated No
Health authority Japan: Pharmaceuticals and Medical Devices Agency
Study type Observational

Clinical Trial Summary

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


Recruitment information / eligibility

Status Completed
Enrollment 30
Est. completion date
Est. primary completion date August 2014
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 20 Years and older
Eligibility 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 Design

Observational Model: Cohort, Time Perspective: Prospective


Related Conditions & MeSH terms


Intervention

Device:
RS-3000 Lite


Locations

Country Name City State
Japan Nabeta Ganaka Iin Okazaki Aichi

Sponsors (1)

Lead Sponsor Collaborator
Nidek Co. LTD.

Country where clinical trial is conducted

Japan, 

Outcome

Type Measure Description Time frame Safety issue
Primary Retinal thickness and Optic Disc Analysis Time frame is the maximum duration of hospital stay. 3 hours No
Secondary Number of participants with adverse events 1day Yes
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