GlaucomaNCT01384487
Nidek RS3000 Comparative Study
An observational study of Glaucoma and Retinal Disease, run by Nidek Co. LTD. at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Glaucoma, Retinal Disease, Corneal Disease
- How many people
- 89 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2011to Nov 2011
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Primary care clinic
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Hamilton Glaucoma Center
La Jolla, California, 92093-0946
About this 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.
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.
- Conditions
- Glaucoma, Retinal Disease, Corneal Disease
- Keywords
- Viewing and axial cross sectional imaging of ocular, structures, including the anterior chamber
- Medical subject headings
- Glaucoma, Retinal Diseases, Corneal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Normal Eyes | Eyes without disease | |
| Eyes with Glaucoma | Not described | |
| Eyes with Retinal Disease | Not described | |
| Eyes with Corneal Disease | Including post keratorefractive surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total Retinal Thickness
Measured: One Visit
Inner Retinal Thickness
Measured: One Visit
Outer Retinal Thickness
Measured: One Visit
RNFL Thickness
Measured: One Visit
Optic Disc Analysis
Measured: One Visit
G Chart
Measured: One Visit
Anterior Chamber Angle Image
Measured: One Visit
SLO Image
Measured: One Visit
Pachymetry
Measured: One Visit
Secondary outcomes (1)
Any adverse events
Measured: One Visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jun 2011 (estimated)
- Study startJun 2011
- Primary completionNov 2011
- Study completionNov 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GlaucomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 89 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nidek Co. LTD.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Robert Weinreb, M.D., Principal investigator, UCSD, Hamilton Glaucoma Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01384487
- Sponsor's protocol ID
- Nidek RS3000-1
- Status last verified
- Feb 2012
- First submitted
- 27 Jun 2011
- Last updated
- 20 Feb 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT01384487
- Acronym / sponsor ID
- Nidek RS3000-1
- Conditions
- Glaucoma, Retinal Disease, Corneal Disease
- Keywords
- Viewing and axial cross sectional imaging of ocular, structures, including the anterior chamber
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 89 participants (actual)
- Lead sponsor
- Nidek Co. LTD.Industry (pharma, biotech, devices)
- Study start
- Jun 2011
- Primary completion
- Nov 2011 (actual)
- Study completion
- Nov 2011 (actual)
- First posted
- 29 Jun 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Normal Eyes | – | –Eyes without disease |
| Eyes with Glaucoma | – | – |
| Eyes with Retinal Disease | – | – |
| Eyes with Corneal Disease | – | –Including post keratorefractive surgery |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Primary care clinic
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Total Retinal Thickness
Time frame: One Visit
Inner Retinal Thickness
Time frame: One Visit
Outer Retinal Thickness
Time frame: One Visit
RNFL Thickness
Time frame: One Visit
Optic Disc Analysis
Time frame: One Visit
G Chart
Time frame: One Visit
Anterior Chamber Angle Image
Time frame: One Visit
SLO Image
Time frame: One Visit
Pachymetry
Time frame: One Visit
1 secondary outcome
Any adverse events
Time frame: One Visit
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Feb 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Robert Weinreb, M.D. principal investigator
UCSD, Hamilton Glaucoma Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Glaucoma and Retinal Disease, run by Nidek Co. LTD. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Feb 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total Retinal Thickness (time frame: One Visit). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Feb 2012.