Nidek RS3000 Comparative Study

Nidek

Status: Completed

Conditions: Corneal Disease; Glaucoma; Retinal Disease

Study type: Observational

Funder types: Industry

Identifiers

NCT01384487

Nidek RS3000-1

Details and patient eligibility

About

The primary objective of this clinical study is to compare the Nidek RS-3000 Optical Coherence Tomography (OCT) device to the Optovue RTVue OCT. The secondary objective is to evaluate any adverse events found during the clinical study.

Enrollment: 89 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

1. Subjects of legal age and who have full legal capacity to volunteer on the date the informed consent is signed.
2. Subjects who follow the instructions by Principal/Clinical Investigator or clinical staff at the clinical site, and can visit on a scheduled examination date.
3. Subjects who sign an informed consent form to participate in the clinical study.
4. Subjects who agree to take the qualifying examination and RS-3000 and RTVue data acquisition.

Exclusion criteria

1. Diabetes mellitus (DM) and/or diabetic retinopathy
2. Hypertension (HT)
3. Cerebral infarction, cerebral hemorrhage, cranial nerve neoplasm and other central nervous system diseases affecting vision
4. Cardiac, hepatic, renal and hematologic diseases
5. Current systemic administration of steroid
6. History of anticancer agent etc.
7. Optically-stimulated epileptic seizure
8. Dementia
9. Subjects who have other life threatening and debilitating systemic diseases

NOTE: Additional detailed inclusion/exclusion ophthalmic criteria dependent upon study population also exist

Trial design

89 participants in 4 patient groups

Normal Eyes

Description:

Eyes without disease

Eyes with Glaucoma

Eyes with Retinal Disease

Eyes with Corneal Disease

Description:

Including post keratorefractive surgery