RS-3000 Lite Agreement Study

Completed

• Conditions: Healthy
• Interventions: Device: RS-3000 Lite

• Registration Number: NCT02198560
• Lead Sponsor: Nidek Co. LTD.

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2014-07-17
• Study First Submitted QC: 2014-07-22
• Study First Posted: 2014-07-23
• Study Start: 2014-08
• Primary Completion: 2014-08
• Status Verified: 2014-09
• Last Update Submitted: 2014-09-09
• Last Update Posted: 2014-09-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Normal (Eyes without pathology)	RS-3000 Lite	-

Primary Outcome Measures

Name	Time	Method
Retinal thickness and Optic Disc Analysis	3 hours	Time frame is the maximum duration of hospital stay.

Secondary Outcome Measures

Name	Time	Method
Number of participants with adverse events	1day

Trial Locations

Locations (1)

Nabeta Ganaka Iin; 🇯🇵 Okazaki, Aichi, Japan