RS-3000 Lite Agreement Study

Nidek

Status: Completed

Conditions: Healthy

Treatments: Device: RS-3000 Lite

Study type: Observational

Funder types: Industry

Identifiers

NCT02198560

NRL-1

Details and patient eligibility

About

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

Enrollment: 30 patients

Sex: All

Ages: 20+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

30 participants in 1 patient group

Normal (Eyes without pathology)

Treatment:

Device: RS-3000 Lite