Expired Study
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La Jolla, California 92093


Purpose:

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.


Criteria:

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 is Available At:


Original ID:

Nidek RS3000-1


NCT ID:

NCT01384487


Secondary ID:


Study Acronym:


Brief Title:

Nidek RS3000 Comparative Study


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.


Overall Status:

Completed


Study Phase:

N/A


Genders:

Both


Minimum Age:

18 Years


Maximum Age:

N/A


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

Nidek Co. LTD.


Oversight Authority:

United States: Institutional Review Board


Reasons Why Stopped:


Study Type:

Observational


Study Design:

Observational Model: Case Control, Time Perspecti


Number of Arms:

0


Number of Groups:

4


Total Enrollment:

89


Enrollment Type:

Actual


Overall Contact Information

Official Name:Robert Weinreb, M.D.
Principal Investigator
UCSD, Hamilton Glaucoma Center

Study Dates

Start Date:June 2011
Completion Date:November 2011
Completion Type:Actual
Primary Completion Date:November 2011
Primary Completion Type:Actual
Verification Date:February 2012
Last Changed Date:February 17, 2012
First Received Date:June 27, 2011

Study Outcomes

Outcome Type:Primary Outcome
Measure:Total Retinal Thickness
Time Frame:One Visit
Safety Issues:False
Outcome Type:Primary Outcome
Measure:Inner Retinal Thickness
Time Frame:One Visit
Safety Issues:False
Outcome Type:Primary Outcome
Measure:Outer Retinal Thickness
Time Frame:One Visit
Safety Issues:False
Outcome Type:Primary Outcome
Measure:RNFL Thickness
Time Frame:One Visit
Safety Issues:False
Outcome Type:Primary Outcome
Measure:Optic Disc Analysis
Time Frame:One Visit
Safety Issues:False
Outcome Type:Primary Outcome
Measure:G Chart
Time Frame:One Visit
Safety Issues:False
Outcome Type:Primary Outcome
Measure:Anterior Chamber Angle Image
Time Frame:One Visit
Safety Issues:False
Outcome Type:Primary Outcome
Measure:SLO Image
Time Frame:One Visit
Safety Issues:False
Outcome Type:Primary Outcome
Measure:Pachymetry
Time Frame:One Visit
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:Any adverse events
Time Frame:One Visit
Safety Issues:True

Study Interventions

There are no available Study Interventions

Study Arms

Study Arm Type:Other
Arm Name:Normal Eyes
Description:Eyes without disease
Study Arm Type:Other
Arm Name:Eyes with Glaucoma
Study Arm Type:Other
Arm Name:Eyes with Retinal Disease
Study Arm Type:Other
Arm Name:Eyes with Corneal Disease
Description:Including post keratorefractive surgery

Study Agencies

Agency Class:Industry
Agency Type:Lead Sponsor
Agency Name:Nidek Co. LTD.

Samples and Retentions

Study Population: Primary care clinic
Sample Method:Non-Probability Sample

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: October 09, 2019

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