Nidek RS3000 Comparative Study

Completed

Conditions studied: Glaucoma, Retinal Disease, Corneal Disease

In brief

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.

Key facts

Study ID

NCT01384487

Run by

Nidek Co. LTD.

People needed

89

Starts

2011-06-01

Expected to finish

2011-11-01

Last updated by the study team

2012-02-20

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

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

You may not qualify if…

• Diabetes mellitus (DM) and/or diabetic retinopathy
• Hypertension (HT)
• Cerebral infarction, cerebral hemorrhage, cranial nerve neoplasm and other central nervous system diseases affecting vision
• Cardiac, hepatic, renal and hematologic diseases
• Current systemic administration of steroid
• History of anticancer agent etc.
• Optically-stimulated epileptic seizure
• Dementia
• Subjects who have other life threatening and debilitating systemic diseases
• NOTE: Additional detailed inclusion/exclusion ophthalmic criteria dependent upon study population also exist

Where it is running

• Hamilton Glaucoma Center — La Jolla, California, United States

Full record on ClinicalTrials.gov

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