RS-3000 Lite Agreement Study

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02198560

Enrollment

Registered

2014-07-23

Start date

2014-08-31

Completion date

Unknown

Last updated

2014-09-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy

Keywords

Normal (Eyes without pathologies)

Brief summary

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

Interventions

DEVICERS-3000 Lite

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

20 Years to No maximum

Healthy volunteers

Yes

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

Design outcomes

Primary

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

Secondary

Measure	Time frame
Number of participants with adverse events	1day

Countries

Japan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026