RS-3000 Lite Agreement Study

N/ACompletedNCT02198560

Nidek Co. LTD.30 enrolled

Overview

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

Study Type

OBSERVATIONAL

Enrollment

Conditions

Healthy

Interventions

RS-3000 LiteDEVICE

Eligibility

Sex: ALLMin age: 20 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Nabeta Ganaka Iin

Okazaki, Aichi-ken, Japan

Outcomes

Primary Outcomes

Retinal thickness and Optic Disc Analysis

Time frame is the maximum duration of hospital stay.

Time frame: 3 hours

Secondary Outcomes

Number of participants with adverse events

Time frame: 1day

Data from ClinicalTrials.gov

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