Nidek RS3000 Comparative Study

Glaucoma Clinical Trial

Official title:

Comparative Study of the Nidek Optical Coherence Tomography RS-3000 and the RTVue OCT Predicate Device for the Measurements of Retinal and RNFL Thickness, Optic Disc Analysis, Pachymetry, Anterior Chamber Imaging and SLO Imaging.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01384487
• Other study ID #: Nidek RS3000-1
• Status: Completed
• Phase: N/A
• First received: June 27, 2011
• Last updated: February 17, 2012
• Start date: June 2011
• Est. completion date: November 2011

Study information

• Verified date: February 2012
• Source: Nidek Co. LTD.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 89
• Est. completion date: November 2011
• Est. primary completion date: November 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Corneal Disease
• Corneal Diseases
• Glaucoma
• Retinal Disease
• Retinal Diseases

Locations

Country	Name	City	State
United States	Hamilton Glaucoma Center	La Jolla	California

Sponsors (1)

Lead Sponsor	Collaborator
Nidek Co. LTD.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Total Retinal Thickness		One Visit	No
Primary	Inner Retinal Thickness		One Visit	No
Primary	Outer Retinal Thickness		One Visit	No
Primary	RNFL Thickness		One Visit	No
Primary	Optic Disc Analysis		One Visit	No
Primary	G Chart		One Visit	No
Primary	Anterior Chamber Angle Image		One Visit	No
Primary	SLO Image		One Visit	No
Primary	Pachymetry		One Visit	No
Secondary	Any adverse events		One Visit	Yes